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Device Explorer · FDA GUDID · GMDN 61648

Dental prosthesis bite verification device

A device intended to aid in the fabrication of a dental prosthesis (e.g., crown, bridge) by connecting the try-in prosthesis to the laboratory working model and to the patient for the purpose of verifying the fit and appearance of the final prosthesis before p

US‑registered devices244in commercial distribution
Companies6labelers on GUDID
Single‑use98%of device records
Sterile0%labelled sterile
Prescription27%Rx‑only share
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Share of device records

Prismatik Dentalcraft, Inc17270%
Henry Schein, Inc.5121%
Vertex-Dental B.V.94%
Coltene/Whaledent Inc62%
Preat Corporation42%
Ivoclar Vivadent, Inc.21%

Top labelers

CompanyDevicesShare
Prismatik Dentalcraft, Inc17270%
Henry Schein, Inc.5121%
Vertex-Dental B.V.94%
Coltene/Whaledent Inc62%
Preat Corporation42%
Ivoclar Vivadent, Inc.21%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PreatNobel3i CertainCAMLOGInclusive®Inclusivesmile designAccu TracZirluxVertex-Dental BVCeramill

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

FDA product codes

CodeNameDevices
NDPAccessories, implant, dental, endosseous170
NDPACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS53
EEAPLATE, BASE, SHELLAC9
NDPAccessories, Implant, Dental, Endosseous8
EILGAUGE, DEPTH, INSTRUMENT, DENTAL4
EGGATTACHMENT, PRECISION, ALL2

GMDN & GCC registration

  • GMDN code 61648 · non‑implantable
  • Single‑use 98% · sterile 0% · Rx‑only 27% · 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

No structured size data on the register.

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

How many dental prosthesis bite verification device products are registered in the US?

244 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental prosthesis bite verification device", from 6 companies. The largest labeler is Prismatik Dentalcraft, Inc with 70% of records.

Which FDA product codes apply?

NDP (Accessories, implant, dental, endosseous), NDP (ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS), EEA (PLATE, BASE, SHELLAC), NDP (Accessories, Implant, Dental, Endosseous)

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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