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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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Bite Buddy - D8161447000

A thermoplastic material designed to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. It is composed of a mixture of natural resins, fillers, and lubricants. This is a single-use device.
ALL DENTAL PRODX
144700
In Commercial Distribution

  • D8161447001 ()
  • D8161447000 ()


  • Composite dental impression material

BONDWELL - D832900MW41

Mixing Wells, 4-Well, White
PLASDENT CORPORATION
900MW-4
In Commercial Distribution

  • D832900MW40 ()
  • D832900MW41 ()
  • D832900MWB41 ()
900MW-4

  • Dental material mixing surface, chairside, single-use

BONDWELL - D832900MW21

Mixing Wells, 2-Well, White
PLASDENT CORPORATION
900MW-2
In Commercial Distribution

  • D832900MWB21 ()
  • D832900MW21 ()
  • D832900MW20 ()
900MW-2

  • Dental material mixing surface, chairside, single-use

PROOF - D832800121

Disposable Caps, 21", Blue
PLASDENT CORPORATION
8001-2
In Commercial Distribution

  • D832800122 ()
  • D832800121 ()
  • D832800120 ()
8001-2

  • Surgical cap, single-use

Steril Peel - D830221442RXEU9

STERIL-PEEL ROLL 12" X 656' EU
GS Medical Packaging Inc
221442RXEU
In Commercial Distribution

  • D830221442RXEU0 ()
  • D830221442RXEU9 ()


  • Sterilization packaging, single-use

Steril Peel - D830221439RX9

STERIL-PEEL TUBING/ROLL 9" X 656'
GS Medical Packaging Inc
221439RX
In Commercial Distribution

  • D830221439RX0 ()
  • D830221439RX9 ()


  • Sterilization packaging, single-use

Steril Peel - D830221434RX9

STERIL-PEEL TUBING/ROLL 4" X 656'
GS Medical Packaging Inc
221434RX
In Commercial Distribution

  • D830221434RX0 ()
  • D830221434RX9 ()


  • Sterilization packaging, single-use

Plasdent - D832CTR021

Cotton Rolls, Non-Sterile, #2
PLASDENT CORPORATION
CTR-02
In Commercial Distribution

  • D832CTR022 ()
  • D832CTR021 ()
  • D832CTR020 ()
CTR-02

  • Dental cotton roll

Plasdent - D832CTA061

6" Cotton Tip Applicators, Non-Sterile
PLASDENT CORPORATION
CTA-06
In Commercial Distribution

  • D832CTA062 ()
  • D832CTA061 ()
  • D832CTA060 ()
CTA-06

  • General-purpose absorbent tip applicator/swab, single-use

Plasdent - D832CTA031

3" Cotton Tip Applicators, Non-Sterile
PLASDENT CORPORATION
CTA-03
In Commercial Distribution

  • D832CTA032 ()
  • D832CTA031 ()
  • D832CTA030 ()
CTA-03

  • General-purpose absorbent tip applicator/swab, single-use
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