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Device Explorer · FDA GUDID · GMDN 38643

Resin artificial teeth

Prefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.

US‑registered devices79,842in commercial distribution
Companies45labelers on GUDID
Single‑use54%of device records
Sterile0%labelled sterile
Prescription71%Rx‑only share
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Share of device records

Ivoclar Vivadent Aktiengesellschaft11,45514%
Vita - Zahnfabrik H. Rauter Gesellschaft Mit Beschränkter Haftung & Co Kommanditgesellschaft7,92910%
Merz Dental Gmbh7,81510%
The Myerson Company Limited7,5829%
Candulor Ag6,4278%
Davis Schottlander & Davis Limited5,9107%
Dentsply International Inc.5,4927%
Yamahachi Dental Mfg.,Co.4,6756%

Top labelers

CompanyDevicesShare
Ivoclar Vivadent Aktiengesellschaft11,45514%
Vita - Zahnfabrik H. Rauter Gesellschaft Mit Beschränkter Haftung & Co Kommanditgesellschaft7,92910%
Merz Dental Gmbh7,81510%
The Myerson Company Limited7,5829%
Candulor Ag6,4278%
Davis Schottlander & Davis Limited5,9107%
Dentsply International Inc.5,4927%
Yamahachi Dental Mfg.,Co.4,6756%
Wright Health Group Limited4,2245%
Kulzer Gmbh3,9935%
Polident D.O.O.3,6745%
Union Dental Sa3,1954%

Company = labeler of record on GUDID. 45 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Resin Teeth / DCL / PEResin Teeth S PE / S DCLSR Phonares IIISOTEK, MDC DentalNewtek, MDC DentalDenture TeethSHINING 3D®UltraPrint Denture Teeth UVSynthetic Polymer TeethDentoluxx VMonarchDentavitDentorium4natur Posterior Denture Teeth BL3:P1U4natur Posterior Denture Teeth BL3:P1L4natur Posterior Denture Teeth BL3:P6U

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

FDA product codes

CodeNameDevices
ELMDenture, plastic, teeth55,690
ELMDenture, Plastic, Teeth38,338
EBGCrown And Bridge, Temporary, Resin397
PZYAdditively Manufactured, Preformed, Resin Denture Tooth209
EBIResin, Denture, Relining, Repairing, Rebasing159
PZYAdditively manufactured, preformed, resin denture tooth67

GMDN & GCC registration

  • GMDN code 38643 · non‑implantable
  • Single‑use 54% · sterile 0% · Rx‑only 71% · OTC 10%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Weight (Kilogram) · 5,925Total Volume (Liter) · 7

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

No closely related category with 50+ devices.

How many resin artificial teeth products are registered in the US?

79,842 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Resin artificial teeth", from 45 companies. The largest labeler is Ivoclar Vivadent Aktiengesellschaft with 14% of records.

Which FDA product codes apply?

ELM (Denture, plastic, teeth), ELM (Denture, Plastic, Teeth), EBG (Crown And Bridge, Temporary, Resin), PZY (Additively Manufactured, Preformed, Resin Denture Tooth)

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.

How do I get quotes?

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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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