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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Medline Industries, Inc. - 10195327529932

PROVIDENCE CA MINOR PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ35372K
In Commercial Distribution

  • 40195327529933 ()
  • 10195327529932 ()
DYNJ35372K

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327529628

PROVIDENCE CA LAP CHOLE
MEDLINE INDUSTRIES, INC.
DYNJ35090J
In Commercial Distribution

  • 40195327529629 ()
  • 10195327529628 ()
DYNJ35090J

  • General surgical procedure kit, non-medicated, single-use

iCE Surgical Light - 00684706006506

Series1 700DT Dual CA 1300,1150 CA DY 9P SL-30M, Barco MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706006506 ()
C17D545K

  • Operating room light

iCE Surgical Light - 00684706006490

Series1 700DT Dual CA 1300,1150 CA DY 3P SL-30M, Barco MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706006490 ()
C17D543K

  • Operating room light

iCE Surgical Light - 00684706001228

S3 300DT 2xSgl CA 1x Dual CA 2x1150,1000,850 RS,2x30M 1xMH1
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001228 ()
C33SDS4324R331

  • Operating room light

GIBSON HEALTHCARE - 00366975013149

Gibson Healthcare MTA Unidose Pouch Sample
BENCO DENTAL SUPPLY CO.
5265-750
In Commercial Distribution

  • 00366975013149 ()


  • Endodontic filling/sealing material

GIBSON HEALTHCARE - 00366975013132

Gibson Healthcare MTA White
BENCO DENTAL SUPPLY CO.
5253-754
In Commercial Distribution

  • 00366975013132 ()


  • Endodontic filling/sealing material

GIBSON HEALTHCARE - 00366975012210

Gibson Healthcare MTA BioCeramic Root Canal Sealer 9G Syringe
BENCO DENTAL SUPPLY CO.
5245-601
In Commercial Distribution

  • 00366975012210 ()


  • Endodontic filling/sealing material

DIA-ROOT BIO MTA - 08806383565783

DIA-ROOT BIO MTA is used for pulp capping (direct pulp capping or partial pulpotomy) and repair of root perforation. Other indications for use include : repair of root resorption, root end filling, apexification, and pediatric pulpotomy.
DiaDent Group International
DIA-ROOT BIO MTA 0.5g
In Commercial Distribution

  • 08806383565783 ()
1003-601

  • Endodontic filling/sealing material

Diapex Plus - 08806383564694

Diapex Plus is a calcium hydroxide paste with iodoform, used as a temporary root canal filling material.
DiaDent Group International
Type B
In Commercial Distribution

  • 08806383564694 ()
A1001-502

  • Endodontic filling/sealing material

DIAPASTE - 08806383564670

Diapaste is a calcium hydroxide paste with barium sulfate, used as a temporary root canal filling material.
DiaDent Group International
Intro Kit
In Commercial Distribution

  • 08806383564670 ()
A1001-405

  • Endodontic filling/sealing material

DIA-PROSEAL - 08806383551038

DIA-PROSEAL Root Canal Sealer is two-component systems that react via an epoxide/amine chemical reaction to case setting.
DiaDent Group International
4g
In Commercial Distribution

  • 08806383551038 ()
1003-202

  • Endodontic filling/sealing material

DIA-PROSEAL - 08806383551021

DIA-PROSEAL Root Canal Sealer is two-component systems that react via an epoxide/amine chemical reaction to case setting.
DiaDent Group International
16g
In Commercial Distribution

  • 08806383551021 ()
1003-201

  • Endodontic filling/sealing material

Dentalis - 04560128312608

Endodontic sealing material, 10mL Liquid
NEO DENTAL CHEMICAL PRODUCTS CO.,LTD.
Liquid
In Commercial Distribution

  • 04560128312608 ()


  • Endodontic filling/sealing material

Dentalis - 04560128312592

Endodontic sealing material, 15g Powder
NEO DENTAL CHEMICAL PRODUCTS CO.,LTD.
Powder
In Commercial Distribution

  • 04560128312592 ()


  • Endodontic filling/sealing material

Dentalis - 04560128312585

Endodontic sealing material, 15g Powder, 10mL Liquid
NEO DENTAL CHEMICAL PRODUCTS CO.,LTD.
Set
In Commercial Distribution

  • 04560128312585 ()


  • Endodontic filling/sealing material

AH PLUS JET - D010606201181

AH Plus Jet Refill Kit is a 2 component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Jet is received in a syringe (D010606201180) delivery for homogeneous mixing of both pastes.
Dentsply De Trey GmbH
60620118
In Commercial Distribution

  • D010606201181 ()
  • D010606201180 ()

  • Weight: 15 Gram
  • Paste
60620118

  • Endodontic filling/sealing material

AH PLUS JET - D010606201151

AH Plus Jet Starter Kit is a 2 component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Jet is received in a syringe (D010K3001600) delivery for homogeneous mixing of both pastes. With its supporting accessories (Mixing/Intraoral Tips, Mixing Pad and Organizer Tray) it can be classified as a convenience kit.
Dentsply De Trey GmbH
60620115
In Commercial Distribution

  • D010606201151 ()

  • Weight: 15 Gram
  • Paste
60620115

  • Endodontic filling/sealing material

AH PLUS ROOTCANAL - D010606201101

AH Plus Refill Kit is a two-component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Root Canal Sealer in tubes for manual mixing of Paste A + B (D010K3018020 and D010K3018030). With its supporting accessory (Mixing Pad) it can be classified as a convenience kit.
Dentsply De Trey GmbH
60620110
In Commercial Distribution

  • D010606201101 ()

  • Paste
  • Total Volume: 4 Milliliter
60620110

  • Endodontic filling/sealing material

AH 26 - D010606200021

AH 26 SILVERFREE RESIN Refill is a refill item of the 2 component powder/resin root canal filling material containing a resin tube (D010K3019120).
Dentsply De Trey GmbH
60620002
In Commercial Distribution

  • D010606200021 ()

  • Paste
  • Weight: 10 Gram
60620002

  • Endodontic filling/sealing material

AH PLUS JET - D0106670071

AH Plus Jet Refill Kit is a 2 component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Jet is received in a syringe delivery for homogeneous mixing of both pastes.
Dentsply De Trey GmbH
667007
In Commercial Distribution

  • D0106670071 ()
  • D0106670070 ()

  • Paste
  • Weight: 15 Gram
667007

  • Endodontic filling/sealing material

AH PLUS JET - D0106670051

AH Plus Jet Starter Kit is a 2 component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Jet is received in a syringe delivery for homogeneous mixing of both pastes. With its supporting accessories (Mixing/Intraoral Tips, Mixing Pad and Organizer Tray) it can be classified as a convenience kit.
Dentsply De Trey GmbH
667005
In Commercial Distribution

  • D0106670051 ()

  • Weight: 15 Gram
  • Paste
667005

  • Endodontic filling/sealing material

AH PLUS ROOTCANAL - D0106670031

AH Plus Kit is a two-component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Root Canal Sealer in tubes for manual mixing of Paste A + B. With its supporting accessory (Mixing Pad) it can be classified as a convenience kit.
Dentsply De Trey GmbH
667003
In Commercial Distribution

  • D0106670031 ()

  • Paste
  • Total Volume: 4 Milliliter
667003

  • Endodontic filling/sealing material

AH 26 - D010606201011

AH 26 Refill is a 2 component powder/resin root canal filling material consisting of a powder jar (D010K3019010) and a resin tube (D010K3019120)
Dentsply De Trey GmbH
60620101
In Commercial Distribution

  • D010606201011 ()
  • D010606201010 ()

  • Weight: 8 Gram
  • Paste
  • Powder
  • Weight: 10 Gram
60620101

  • Endodontic filling/sealing material

Well-Root ST - 08809254458146

Root Canal Sealing Material; Type F
VERICOM CO., LTD.
WR105-S00F
In Commercial Distribution

  • 08809254458146 ()


  • Endodontic filling/sealing material

Well-Paste - 08809254452328

Calcium Hydroxide with Barium Sulfate ; Well-Paste 2g x 1 syringe
VERICOM CO., LTD.
WS102-K000
In Commercial Distribution

  • 08809254452328 ()


  • Endodontic filling/sealing material

Well-Pex - 08809254452304

Calcium Hydroxide with Iodoform ; Well-Pex 2g x 1 syringe
VERICOM CO., LTD.
WP102-K000
In Commercial Distribution

  • 08809254452304 ()


  • Endodontic filling/sealing material

Well-Pex - 08809254454216

Calcium Hydroxide with Iodoform; Well-Pex 0.5 X 1syringe
VERICOM CO., LTD.
WP105-S000
In Commercial Distribution

  • 08809254454216 ()


  • Endodontic filling/sealing material

Well-Paste - 08809254454209

Calcium Hydroxide with Barium Sulfate; Well-Paste 0.5g X 1syringe
VERICOM CO., LTD.
WS105-S000
In Commercial Distribution

  • 08809254454209 ()


  • Endodontic filling/sealing material

Well-Root ST - 08809254458139

Root Canal Sealing Material; Type E
VERICOM CO., LTD.
WR102-K00E
In Commercial Distribution

  • 08809254458139 ()


  • Endodontic filling/sealing material

Well-Root ST - 08809254458115

Root Canal Sealing Material; Type C
VERICOM CO., LTD.
WR102-K00C
In Commercial Distribution

  • 08809254458115 ()


  • Endodontic filling/sealing material

Diapaste - 08806383500166

No Description
DiaDent Group International
Intro Kit
In Commercial Distribution

  • 08806383500166 ()


  • Endodontic filling/sealing material

Diapaste - 08806383500159

No Description
DiaDent Group International
Refill Kit
In Commercial Distribution

  • 08806383500159 ()


  • Endodontic filling/sealing material

Diapaste - 08806383500142

No Description
DiaDent Group International
Type C
In Commercial Distribution

  • 08806383500142 ()


  • Endodontic filling/sealing material

Diapaste - 08806383500135

No Description
DiaDent Group International
Type B
In Commercial Distribution

  • 08806383500135 ()


  • Endodontic filling/sealing material

Diapaste - 08806383500128

No Description
DiaDent Group International
Type A
In Commercial Distribution

  • 08806383500128 ()


  • Endodontic filling/sealing material

Diapex - 08806383500111

No Description
DiaDent Group International
Type B
In Commercial Distribution

  • 08806383500111 ()


  • Endodontic filling/sealing material

Diapex - 08806383500067

No Description
DiaDent Group International
Refill Kit
In Commercial Distribution

  • 08806383500067 ()
1001-302

  • Endodontic filling/sealing material

Diapex - 08806383500050

No Description
DiaDent Group International
Type A
Not in Commercial Distribution

  • 08806383500050 ()
1001-301

  • Endodontic filling/sealing material

CeraSeal 0.5-BOX - 08806387894841

CeraSeal is used for root canal filling after the removal of infected pulp tissue in the root canal. CeraSeal is in the form of a flowable paste and can be immediately applied inside the root canal using a disposable tip. material, and a thickening agent. This product characteristically cures slowly by absorbing the ambient water inside the root canal. It is white and aesthetic.
Meta Biomed Co., Ltd.
9484
In Commercial Distribution

  • 08806387894841 ()


  • Endodontic filling/sealing material

KometSeal - 08806387894834

KometsSeal root canal sealer is a two component paste:paste device based upon epoxy-amine resin chemistry. This sealer is easy to mix and adapts closely to the walls of the prepared root canal and provides outstanding long-term dimensional stability with minimal shrinkage upon setting.
Meta Biomed Co., Ltd.
9483
In Commercial Distribution

  • 08806387894834 ()


  • Endodontic filling/sealing material

CeraSeal 0.5-Pouch - 08806387894810

CeraSeal is used for root canal filling after the removal of infected pulp tissue in the root canal. CeraSeal is in the form of a flowable paste and can be immediately applied inside the root canal using a disposable tip. material, and a thickening agent. This product characteristically cures slowly by absorbing the ambient water inside the root canal. It is white and aesthetic.
Meta Biomed Co., Ltd.
9481
In Commercial Distribution

  • 08806387894810 ()


  • Endodontic filling/sealing material

CeraSeal - 08806387894124

CeraSeal is used for root canal filling after the removal of infected pulp tissue in the root canal. CeraSeal is in the form of a flowable paste and can be immediately applied inside the root canal using a disposable tip. material, and a thickening agent. This product characteristically cures slowly by absorbing the ambient water inside the root canal. It is white and aesthetic.
Meta Biomed Co., Ltd.
9412
In Commercial Distribution

  • 08806387894124 ()


  • Endodontic filling/sealing material

CeraSeal Disposable Tips(10ea) - 08806387860037

CeraSeal is used for root canal filling after the removal of infected pulp tissue in the root canal. CeraSeal is in the form of a flowable paste and can be immediately applied inside the root canal using a disposable tip. material, and a thickening agent. This product characteristically cures slowly by absorbing the ambient water inside the root canal. It is white and aesthetic.
Meta Biomed Co., Ltd.
6003
In Commercial Distribution

  • 08806387860037 ()


  • Endodontic filling/sealing material

DIA-ROOT BIO Sealer - 08806383565790

DIA-ROOT BIO Sealer is a MTA (mineral trioxide aggregate) based root canal sealer that provides complete and permanent sealing of root canals. It can be used with or without root canal obturation materials.
DiaDent Group International
DIA-ROOT BIO Sealer 2.0g
In Commercial Distribution

  • 08806383565790 ()
1003-701

  • Endodontic filling/sealing material

Diapex Plus - 08806383564724

DIAPEX PLUS is a calcium hydroxide paste with iodoform, used as a temporary root canal filling material.
DiaDent Group International
INTRO KIT
In Commercial Distribution

  • 08806383564724 ()
A1001-505

  • Endodontic filling/sealing material

Diapex Plus - 08806383564717

DIAPEX PLUS is a calcium hydroxide paste with iodoform, used as a temporary root canal filling material.
DiaDent Group International
REFILL KIT
In Commercial Distribution

  • 08806383564717 ()
A1001-504

  • Endodontic filling/sealing material

Diapex Plus - 08806383564700

DIAPEX PLUS is a calcium hydroxide paste with iodoform, used as a temporary root canal filling material.
DiaDent Group International
Type C
In Commercial Distribution

  • 08806383564700 ()
A1001-503

  • Endodontic filling/sealing material

Diapex Plus - 08806383564687

Diapex Plus is a calcium hydroxide paste with iodoform, used as a temporary root canal filling material.
DiaDent Group International
Type A
In Commercial Distribution

  • 08806383564687 ()
A1001-501

  • Endodontic filling/sealing material

DIAPASTE - 08806383564663

Diapaste is a calcium hydroxide paste with barium sulfate, used as a temporary root canal filling material.
DiaDent Group International
Refill Kit
In Commercial Distribution

  • 08806383564663 ()
A1001-404

  • Endodontic filling/sealing material
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