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Device Explorer · FDA GUDID · GMDN 34799

Composite dental impression material

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. Thi

US‑registered devices122in commercial distribution
Companies13labelers on GUDID
Single‑use28%of device records
Sterile0%labelled sterile
Prescription66%Rx‑only share
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Share of device records

Patterson Dental Supply, Inc.3730%
Prevest Denpro Limited3025%
Harry J Bosworth Company2016%
Axiodent Inc.1512%
Perflex Ltd43%
D.S.I Dental Solutions Ltd43%
All Dental Prodx32%
Cmp Industries Llc32%

Top labelers

CompanyDevicesShare
Patterson Dental Supply, Inc.3730%
Prevest Denpro Limited3025%
Harry J Bosworth Company2016%
Axiodent Inc.1512%
Perflex Ltd43%
D.S.I Dental Solutions Ltd43%
All Dental Prodx32%
Cmp Industries Llc32%
Dmg America, Llc22%
Etgar - Medical Instruments Ltd11%
Bredent Gmbh & Co. Kg11%
Zest Anchors, Llc11%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Plastic for Closed Tray Transfer for Multi-UnitBD ImpressPerflex ThermofixTray material UV pink band,Accusil Heavy BodyAccusil Bite RegistrationAccusil MonophaseAccusil Light BodyAccusil Combo Kit Putty + Light Body (Soft)Accusil Putty (Soft)UltraSil Putty 1000UltraSil Light Body Wash 50ml x 4UltraSil Heavy Body Wash 50ml x 4UltraSil Putty 800Bite BuddyTEMP TABS NATURAL

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
ELWMaterial, Impression51
ELWMATERIAL, IMPRESSION21
EBFMaterial, tooth shade, resin18
EBFMaterial, Tooth Shade, Resin14
EBHMaterial, Impression Tray, Resin6
EBGCrown And Bridge, Temporary, Resin5

GMDN & GCC registration

  • GMDN code 34799 · non‑implantable
  • Single‑use 28% · sterile 0% · Rx‑only 66% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Weight (Gram) · 10Total Volume (Milliliter) · 4Total Volume (Fluid Ounce) · 2Weight (Pound) · 1Weight (Kilogram) · 1

Use these as the dimensions to specify in a tender line.

How many composite dental impression material products are registered in the US?

122 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Composite dental impression material", from 13 companies. The largest labeler is Patterson Dental Supply, Inc. with 30% of records.

Which FDA product codes apply?

ELW (Material, Impression), ELW (MATERIAL, IMPRESSION), EBF (Material, tooth shade, resin), EBF (Material, Tooth Shade, Resin)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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