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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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Renamel® Microhybrid - EDEL6061B30

Renamel® Microhybrid Body B3, Syringe 5g
DeltaMed GmbH
6061B3
In Commercial Distribution

6061B3

  • Dental composite resin

Renamel® Microhybrid - EDEL6061B20

Renamel® Microhybrid Body B2, Syringe 5g
DeltaMed GmbH
6061B2
In Commercial Distribution

6061B2

  • Dental composite resin

Renamel® Microhybrid - EDEL6061A30

Renamel® Microhybrid Body A3, Syringe 5g
DeltaMed GmbH
6061A3
In Commercial Distribution

6061A3

  • Dental composite resin

Renamel® Microhybrid - EDEL6061A20

Renamel® Microhybrid Body A2, Syringe 5g
DeltaMed GmbH
6061A2
In Commercial Distribution

6061A2

  • Dental composite resin

Renamel® Microhybrid - EDEL6061A10

Renamel® Microhybrid Body A1, Syringe 5g
DeltaMed GmbH
6061A1
In Commercial Distribution

6061A1

  • Dental composite resin

Insure® Lite Automix - EDEL605ACL0

Insure® Lite Automix, Syringe 8g
DeltaMed GmbH
605ACL
In Commercial Distribution

605ACL

  • Dental composite resin

Insure® Lite - EDEL6051080

Insure® Lite Simulcure Catalyst, Syringe 3g
DeltaMed GmbH
605108
Not in Commercial Distribution

605108

  • Dental composite resin

Insure® Lite - EDEL6051060

Insure® Lite Yellow Opaque, Syringe 3g
DeltaMed GmbH
605106
Not in Commercial Distribution

605106

  • Dental composite resin

Insure® Lite - EDEL6051040

Insure® Lite Grey Light, Syringe 3g
DeltaMed GmbH
605104
Not in Commercial Distribution

605104

  • Dental composite resin

Onyx HD 500 - 00836462005129

105-8101-500 ONYX HD500 KIT ANEURYS
Micro Therapeutics, Inc.
105-8101-500
In Commercial Distribution

  • 00836462005129 ()


  • Neurovascular embolization plug

Ipana 5% Sodium Fluoride Varnish - Melon - 00060705405333

No Description
MAXILL, INC.
40533
In Commercial Distribution

  • 00060705405333 ()
  • 90060705405336 ()


  • Dental cavity varnish

Ipana 5% Sodium Fluoride Varnish - Bubble Gum - 00060705405326

No Description
MAXILL, INC.
40532
In Commercial Distribution

  • 00060705405326 ()
  • 90060705405329 ()


  • Dental cavity varnish

Ipana 5% Sodium Fluoride Varnish - Wintergreen - 00060705405319

No Description
MAXILL, INC.
40531
In Commercial Distribution

  • 00060705405319 ()
  • 90060705405312 ()


  • Dental cavity varnish

Ipana 5% Sodium Fluoride Varnish - Caramel - 00060705405302

No Description
MAXILL, INC.
40530
In Commercial Distribution

  • 00060705405302 ()
  • 90060705405305 ()


  • Dental cavity varnish

Bandtite Band Cement - 00190746007873

BANDTITE GLASS IONOMER POWDER 100 GMS
AMERICAN ORTHODONTICS CORPORATION
001-972
In Commercial Distribution

  • 00190746007873 ()
001-972

  • Orthodontic bracket adhesive

Bandtite Band Cement - 00190746007866

BANDTITE GLASS IONOMER LIQUID 60 CC
AMERICAN ORTHODONTICS CORPORATION
001-971
In Commercial Distribution

  • 00190746007866 ()
001-971

  • Orthodontic bracket adhesive

Bandtite Band Cement - 00190746007859

BANDTITE GLASS IONOMER CEMENT MINI KIT
AMERICAN ORTHODONTICS CORPORATION
001-970M
Not in Commercial Distribution

  • 00190746007859 ()
001-970M

  • Orthodontic bracket adhesive

Bandtite Band Cement - 00190746007842

BANDTITE GLASS IONOMER CEMENT KIT
AMERICAN ORTHODONTICS CORPORATION
001-970
In Commercial Distribution

  • 00190746007842 ()
001-970

  • Orthodontic bracket adhesive

SEPTODONT N-DURANCE TIP REF 20-0.25G A1 - 00303620001014

No Description
SEPTODONT, INC
01C3011
In Commercial Distribution

  • 00303620001014 ()

  • Weight: 0.25 Gram


  • Dental composite resin

SEPTODONT N'DURANCE CORE B.U. NATRL 2X9G W/T - 00303620000994

No Description
SEPTODONT, INC
01C2601
In Commercial Distribution

  • 00303620000994 ()

  • Weight: 9 Gram


  • Dental composite resin
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