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Device Explorer · FDA GUDID · GMDN 63349

Dental implant suprastructure, permanent, custom-made

A custom-made device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar,

US‑registered devices570in commercial distribution
Companies11labelers on GUDID
Single‑use98%of device records
Sterile0%labelled sterile
Prescription74%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Creo Dent Hudson Valley, Inc.37666%
Truabutment Inc.11620%
Dentis Co. ,Ltd244%
Titan Implant Inc132%
Izenimplant Co., Ltd.81%
Argen Corporation, The71%
Louisiana Dental Implant Lab Llc61%
Implant Solutions Pty Ltd61%

Top labelers

CompanyDevicesShare
Creo Dent Hudson Valley, Inc.37666%
Truabutment Inc.11620%
Dentis Co. ,Ltd244%
Titan Implant Inc132%
Izenimplant Co., Ltd.81%
Argen Corporation, The71%
Louisiana Dental Implant Lab Llc61%
Implant Solutions Pty Ltd61%
American Dental Implant Corporation51%
Implant Logistics, Inc.51%
Cagenix, Inc.41%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

VortexAmerican Dental ImplantArgenISTITAN IMPLANTS INCTITAN IMPLANTS INC.TITAN IMPLANTS, INC.Implant-OneSolidexInosysSOLIDEXsolidexOsteon MedicalCagenix AccuFrame OverdentureCagenix AccuFrame 360Cagenix AccuFrame ICCagenix AccuFrame

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

FDA product codes

CodeNameDevices
NHAAbutment, Implant, Dental, Endosseous561
DZEImplant, Endosseous, Root-Form6
KHAMask, Scavenging2
NSKDentures, Partial1
NSLDentures, Full1
NSMRestoration, Resin1

GMDN & GCC registration

  • GMDN code 63349 · implantable
  • Single‑use 98% · sterile 0% · Rx‑only 74% · OTC 21%
  • 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 implant suprastructure, permanent, custom-made products are registered in the US?

570 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental implant suprastructure, permanent, custom-made", from 11 companies. The largest labeler is Creo Dent Hudson Valley, Inc. with 66% of records.

Which FDA product codes apply?

NHA (Abutment, Implant, Dental, Endosseous), DZE (Implant, Endosseous, Root-Form), KHA (Mask, Scavenging), NSK (Dentures, Partial)

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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