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Device Explorer · FDA GUDID · GMDN 57949

Dental guided surgery reference plate

A non-sterile device in the form of a plate designed for the fabrication of custom-made scan and surgical dental implant templates used by a dentist during the first stage of a guided dental implantation procedure (i.e., drilling holes in the jawbone for impla

US‑registered devices272in commercial distribution
Companies18labelers on GUDID
Single‑use95%of device records
Sterile0%labelled sterile
Prescription26%Rx‑only share
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Share of device records

Dio Corporation17263%
Nobel Biocare Ab5119%
Vertex-Dental B.V.114%
Dms Co., Ltd.93%
Voco Gmbh52%
Sirona Dental Systems Gmbh41%
Applied Dental, Inc.31%
Vericom Co., Ltd.31%

Top labelers

CompanyDevicesShare
Dio Corporation17263%
Nobel Biocare Ab5119%
Vertex-Dental B.V.114%
Dms Co., Ltd.93%
Voco Gmbh52%
Sirona Dental Systems Gmbh41%
Applied Dental, Inc.31%
Vericom Co., Ltd.31%
Maquira Industria De Produtos Odontologicos S/A31%
Shandong Huge Dental Material Corporation21%
Osstem Implant Co.,Ltd.21%
Etgar - Medical Instruments Ltd10%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Nobel Biocare®3D Scanning DeviceSurgical Stent ImplantSurgical GuideE-GuideCEREC Guide 3DentaprintV-Print SGV-Print Try-InV-Print TrayV-Print orthoEZ StentM-PRINT Surgical guide HTOneJet SGMAZIC D SGDIOnavi. Guide

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, Endosseous203
NDPAccessories, implant, dental, endosseous65
KMYPositioner, Tooth, Preformed3
EBHMaterial, Impression Tray, Resin3
EEAPlate, Base, Shellac1
DYTMaintainer, Space Preformed, Orthodontic1

GMDN & GCC registration

  • GMDN code 57949 · non‑implantable
  • Single‑use 95% · sterile 0% · Rx‑only 26% · OTC 1%
  • 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 guided surgery reference plate products are registered in the US?

272 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental guided surgery reference plate", from 18 companies. The largest labeler is Dio Corporation with 63% of records.

Which FDA product codes apply?

NDP (Accessories, Implant, Dental, Endosseous), NDP (Accessories, implant, dental, endosseous), KMY (Positioner, Tooth, Preformed), EBH (Material, Impression Tray, 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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