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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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ROEKO RoekoSeal Automix - E1653491020

No Description
Coltène/Whaledent GmbH + Co. KG
Refill pack Dual-barrel syringe
In Commercial Distribution

  • E1653491020 ()
349102

  • Endodontic filling/sealing material

ROEKO RoekoSeal Automix - E1653491000

No Description
Coltène/Whaledent GmbH + Co. KG
Set
In Commercial Distribution

  • E1653491000 ()
349100

  • Endodontic filling/sealing material

ROEKO GuttaFlow®2 - E165600137020

The ROEKO GuttaFlow®2 Introkit contains 1 x Capsules GuttaFlow®2 (20 pcs), 1 x Canal Tips + Stops (20 pcs), 1 x Adapters for RotoMix™ (3 pcs), 1 x Dispenser, 1 x ROEKO Guttapercha points Top Color ISO 15-40 (100 pcs) and 1 x ROEKO Guttapercha points Greater Taper 0.04 20-45 (60 pcs).
Coltène/Whaledent GmbH + Co. KG
INTROKIT
In Commercial Distribution

  • E165600137020 ()
60013702

  • Endodontic filling/sealing material

ROEKO RoekoSeal Single Dose - E16555430

No Description
Coltène/Whaledent GmbH + Co. KG
SAMPLE
In Commercial Distribution

  • E16555430 ()
5543

  • Endodontic filling/sealing material

MTA-Flow Fast Set - 17540208000421

Endodontic repair cement - 0.25 g capsules
Zendo Direct AG
ZEN-MTA-FLOFST
In Commercial Distribution

  • 27540208000428 ()
  • 17540208000421 ()
  • 07540208000424 ()
ZEN-MTA-FLOFST

  • Endodontic filling/sealing material

MTA Firm-Fast Set - 17540208000414

Endodontic repair cement - 0.25 g capsules
Zendo Direct AG
ZEN-MTA-FRMFSTSET
In Commercial Distribution

  • 27540208000411 ()
  • 17540208000414 ()
  • 07540208000417 ()
ZEN-MTA-FRMFSTSET

  • Endodontic filling/sealing material

MTA Firm- Normal Set - 17540208000407

Endodontic repair cement - 0.25 g capsules
Zendo Direct AG
ZEN-MTA-FRMNSET
In Commercial Distribution

  • 27540208000404 ()
  • 17540208000407 ()
  • 07540208000400 ()
ZEN-MTA-FRMNSET

  • Endodontic filling/sealing material

MTA Capsules - 17540208000391

Endodontic repair cement - Universal; 0.3 g capsules
Zendo Direct AG
ZEN-MTA-UNI
In Commercial Distribution

  • 27540208000398 ()
  • 17540208000391 ()
  • 07540208000394 ()
ZEN-MTA-UNI

  • Endodontic filling/sealing material

SimpliSeal - 00889989077698

ROOT CANAL SEALER
ORMCO CORPORATION
972-0082
In Commercial Distribution

  • 00889989077698 ()


  • Endodontic filling/sealing material

Tubli-Seal EWT Xpress - 00889989074239

Root Canal Sealer-Zinc Oxide Eugenol - Dual Syringe Delivery System (2 - 5mL Syringes)
ORMCO CORPORATION
33641
In Commercial Distribution

  • 00889989074239 ()

  • Weight: 21.4 Gram


  • Endodontic filling/sealing material

Tubli-Seal Xpress - 00889989074222

Root Canal Sealer-Zinc Oxide Eugenol - Dual Syringe Delivery System (2 - 5mL Syringes)
ORMCO CORPORATION
33640
In Commercial Distribution

  • 00889989074222 ()
  • 10889989073031 ()

  • Weight: 21.6 Gram


  • Endodontic filling/sealing material

Sealapex Xpress - 00889989074215

Root Canal Sealer - Dual Syringe Delivery System (2 - 10.5g syringes and mixing tips)
ORMCO CORPORATION
33639
In Commercial Distribution

  • 00889989074215 ()
  • 10889989073062 ()

  • Weight: 21 Gram


  • Endodontic filling/sealing material

Tubli-Seal EWT - 00889989074192

Root Canal Sealer 1 Tube each - Catalyst (5g) and Base (15g)
ORMCO CORPORATION
25903
In Commercial Distribution

  • 00889989074192 ()

  • Weight: 20 Gram


  • Endodontic filling/sealing material

Pulp Canal Sealer - 00889989074178

Root Canal Sealer (1 - Jar (10.5g), 1 - Bottle (4mL)
ORMCO CORPORATION
24875
In Commercial Distribution

  • 00889989074178 ()

  • NET WT: 10.5g - NET VOL: 4mL


  • Endodontic filling/sealing material

Pulp Canal Sealer - 00889989074161

Powder Refill - Root Canal Sealer (Jar, 10.5g each)
ORMCO CORPORATION
24874
In Commercial Distribution

  • 00889989074161 ()
  • 10889989073123 ()

  • Weight: 42 Gram


  • Endodontic filling/sealing material

Pulp Canal Sealer - 00889989074154

Liquid Refill - Root Canal Sealer (Bottle, 4mL each)
ORMCO CORPORATION
24873
In Commercial Distribution

  • 00889989074154 ()
  • 10889989073116 ()

  • Total Volume: 16 Milliliter


  • Endodontic filling/sealing material

Pulp Canal Sealer EWT - 00889989074147

Root Canal Sealer - Extended Work Time (1 - Jar (10.5g), 1 - Bottle (4mL))
ORMCO CORPORATION
24746
In Commercial Distribution

  • 00889989074147 ()

  • NET WT: 10.5g - NET VOL: 4mL


  • Endodontic filling/sealing material

Pulp Canal Sealer EWT - 00889989074130

Powder Refill - Root Canal Sealer - Extended Work Time (Jar, 10.5g each)
ORMCO CORPORATION
24745
In Commercial Distribution

  • 00889989074130 ()
  • 10889989073093 ()

  • Weight: 42 Gram


  • Endodontic filling/sealing material

Sealapex - 00889989074116

Root Canal Sealer (1 Tube each - Catalyst (18g) and Base (12g))
ORMCO CORPORATION
18432
In Commercial Distribution

  • 00889989074116 ()

  • Weight: 30 Gram


  • Endodontic filling/sealing material

Tubli-Seal - 00889989073157

Root Canal Sealer - BULK PK24 ( Catalyst (5g) and Base (15g) each)
ORMCO CORPORATION
01081
In Commercial Distribution

  • 00889989073157 ()
  • 10889989073017 ()

  • Weight: 480 Gram


  • Endodontic filling/sealing material

Tubli-Seal - 00889989073140

Root Canal Sealer 1 Tube each - Catalyst (5g) and Base (15g)
ORMCO CORPORATION
00340
In Commercial Distribution

  • 00889989073140 ()

  • Weight: 20 Gram


  • Endodontic filling/sealing material

ProRoot ES - D716PROROOTES1

ProRoot: ES MTA ProRoot Sealer
TULSA DENTAL PRODUCTS LLC
PROROOTES
In Commercial Distribution

  • D716PROROOTES1 ()
  • D716PROROOTES0 ()

  • Weight: 0.25 Gram
PROROOTES

  • Endodontic filling/sealing material

MULTI-CAL SAMPLE - D701SMULTI2

0.6 mL syringe + mixing tips
PULPDENT CORPORATION
SMULTI
In Commercial Distribution

  • D701SMULTI2 ()

  • Total Volume: 0.6 Milliliter


  • Endodontic filling/sealing material

ROOT CANAL SEALER - D701RSP42

Powder, 4 oz (114 gm)
PULPDENT CORPORATION
RSP4
In Commercial Distribution

  • D701RSP42 ()

  • Weight: 114 Gram


  • Endodontic filling/sealing material

ROOT CANAL SEALER - D701RSP2

Powder, 15 gm
PULPDENT CORPORATION
RSP
In Commercial Distribution

  • D701RSP2 ()

  • Weight: 15 Gram


  • Endodontic filling/sealing material

ROOT CANAL SEALER - D701RSL22

Liquid, 60 mL
PULPDENT CORPORATION
RSL2
In Commercial Distribution

  • D701RSL22 ()

  • Total Volume: 60 Milliliter


  • Endodontic filling/sealing material

Pulpdent Root Canal Sealer Kit - D701RK2

No Description
PULPDENT CORPORATION
RK
In Commercial Distribution

  • D701RK2 ()


  • Endodontic filling/sealing material

FORENDO PASTE - D701FORE2

CALCIUM HYDROXIDE WITH IODOFORM IN SILICON OIL BASE 2.2 gm syringe + 20 applicator tips
PULPDENT CORPORATION
FORE
In Commercial Distribution

  • D701FORE2 ()


  • Endodontic filling/sealing material

ROOT CANAL SEALER - D701RSL2

Liquid, 7.5 mL
PULPDENT CORPORATION
RSL
In Commercial Distribution

  • D701RSL2 ()

  • Total Volume: 7.5 Milliliter


  • Endodontic filling/sealing material

Pressure Syringe® Combo Kit - D701PSK2

Syringe, handle, 30 assorted needles, Pulpdent Root Canal Sealer Kit, 8 oz Wonder Orange
PULPDENT CORPORATION
PSK
In Commercial Distribution

  • D701PSK2 ()


  • Endodontic filling/sealing material

EndoREZ - 00883205107930

EndoREZ Accelerator 20 vial kit
ULTRADENT PRODUCTS, INC.
399
In Commercial Distribution

  • 00883205107930 ()
399

  • Endodontic filling/sealing material

EndoREZ - 00883205107831

EndoREZ Obturation Kit, 0.04 Taper
ULTRADENT PRODUCTS, INC.
5902
In Commercial Distribution

  • 00883205107831 ()
5902

  • Endodontic filling/sealing material

EndoREZ - 00883205107824

EndoREZ Obturation Kit 0.02 Taper
ULTRADENT PRODUCTS, INC.
5901
In Commercial Distribution

  • 00883205107824 ()
5901

  • Endodontic filling/sealing material

EndoREZ - 00883205107817

EndoREZ Mini Obturation Kit
ULTRADENT PRODUCTS, INC.
5904
In Commercial Distribution

  • 00883205107817 ()
5904

  • Endodontic filling/sealing material

Vivid RootFill DC Syringe Kit 5ml - D724S2703241

No Description
PEARSON DENTAL SUPPLIES, INC.
S270324
In Commercial Distribution

  • D724S2703241 ()


  • Endodontic filling/sealing material

Alpha-Cal® - D73541400000020

Alpha-Cal® is a calcium hydroxide paste with Barium Sulfate used as a root canal sealer for the temporary filling of root canals after conventional endodontic treatments. Alpha-Cal® is an aqueous, radiopaque, high pH (>12.0) paste packaged in a syringe ready to be dispensed through disposable tips into the root canal. Kit Contains: 4 x 1g Syringe, 8 Syringe Tips
DENTAL TECHNOLOGIES, INC.
414.0000.002
In Commercial Distribution

  • D73541400000020 ()
  • D73541402020020 ()
414.0000.002

  • Endodontic filling/sealing material

GIBSON - D7443129437

Benco EDTA 8oz
BENCO DENTAL SUPPLY CO.
3129-437
In Commercial Distribution

  • D7443129437 ()

  • Total Volume: 8 Fluid Ounce


  • Endodontic filling/sealing material

EndoREZ - 00883205107848

EndoREZ Obturation Kit, 0.06 Taper
ULTRADENT PRODUCTS, INC.
5903
In Commercial Distribution

  • 00883205107848 ()
5903

  • Endodontic filling/sealing material

EndoREZ - 00883205106803

EndoREZ Refill Kit
ULTRADENT PRODUCTS, INC.
5900
In Commercial Distribution

  • 00883205106803 ()
5900

  • Endodontic filling/sealing material

EndoREZ - 00883205102768

Sample EndoREZ Obturation System
ULTRADENT PRODUCTS, INC.
S2740
In Commercial Distribution

  • 00883205102768 ()
S2740

  • Endodontic filling/sealing material

Endo-Eze - 00883205101594

Endo-Eze MTA FLOW Repair Cement Kit
ULTRADENT PRODUCTS, INC.
3980
In Commercial Distribution

  • 00883205101594 ()
3980

  • Endodontic filling/sealing material

GIBSON - D7443129446

Benco EDTA 2oz
BENCO DENTAL SUPPLY CO.
3149-446
In Commercial Distribution

  • D7443129446 ()

  • Total Volume: 2 Fluid Ounce


  • Endodontic filling/sealing material

Mixint Tip / Intraoral Tip - D01060620111

Mixing Tip/ Intraoral Tip is the mixing and application device to be applied with AH Plus Jet and is available seperately
Dentsply De Trey GmbH
60620116
In Commercial Distribution

  • D01060620110 ()
  • D01060620111 ()

  • Length: 5.2 Centimeter
60620116

  • Endodontic filling/sealing material

Sealapex - 00889989074123

Root Canal Sealer - Bulk Package (24 Tubes each - Catalyst (18g) and Base (12g)
ORMCO CORPORATION
18598
In Commercial Distribution

  • 00889989074123 ()
  • 10889989073055 ()

  • Weight: 720 Gram


  • Endodontic filling/sealing material

Unimed - 06945664849821

One piece ECG Monitor Cable/科洛MECG/3-lead/grabber/AHA/2.5M+0.9M/522/Sage Services GROUP
Unimed Medical Supplies, Inc.
T23-03-30M
In Commercial Distribution

  • 06945664849821 ()


  • Electrocardiographic lead set, reusable

320 P37,SY,2L,2LD,TV & LT COM TIED,STKR - 00840828100847

320 P37,SY,2L,2LD,TV & LT COM TIED,STKR
CURBELL MEDICAL PRODUCTS, INC.
3001-991-144
In Commercial Distribution

  • 00840828100847 ()
229

  • Electrical mains power extension cable

Henry Schein - 00304040037089

Calcium Hydroxide Temporary Root Filling Material
HENRY SCHEIN, INC.
9003663
In Commercial Distribution

  • 00304040037089 ()
9003663

  • Calcium hydroxide dental suspension

Centrix Endo Kit - 00817051021218

Centrix Endo Kit root canal pack
CENTRIX, INC.
360053
In Commercial Distribution

  • 00817051021218 ()


  • Calcium hydroxide dental suspension

Calciject - 00817051020822

Calciject prefilled Calcium Hydroxide paste tips, 24
CENTRIX, INC.
320003
In Commercial Distribution

  • 00817051020822 ()


  • Calcium hydroxide dental suspension

Calcium Hydroxide U.S.P. - D6870010301FG1

Calcium Hydroxide USP 2 oz. (57g)
DENTSPLY INTERNATIONAL INC.
0010301FG
Not in Commercial Distribution

  • D6870010301FG1 ()
  • D6870010301FG0 ()

  • 12 bottles (57g each)
  • Weight: 57 Gram
0010301FG

  • Calcium hydroxide dental suspension
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