Device Explorer · FDA GUDID · GMDN 35261

Chin prosthesis

A sterile device implanted in the soft tissue of the chin to correct chin deformities or improve facial appearance. It is usually made of a polymer material.

US‑registered devices568in commercial distribution
Companies6labelers on GUDID
Single‑use100%of device records
Sterile57%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Implantech Associates, Inc.25545%
Hanson Medical, Inc.19635%
Spectrum Designs Inc6411%
Surgical Technology Laboratories Inc326%
Stryker Leibinger Gmbh & Co. Kg193%
Osteosymbionics, Llc20%

Top labelers

CompanyDevicesShare
Implantech Associates, Inc.25545%
Hanson Medical, Inc.19635%
Spectrum Designs Inc6411%
Surgical Technology Laboratories Inc326%
Stryker Leibinger Gmbh & Co. Kg193%
Osteosymbionics, Llc20%

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

Brand names on the register (sample)

MEDPORST TemporalisSurgiformSURGIFORMPureformPureFormChin ImplantSpectrum Designs MedicalVertical Lengthening ChinVertical Lengthening Chin SizersTerino Square Chin-Style ITerino Square Chin - Style I SizersTerino Square Chin-Style IITerino Square Chin - Style II SizersTerino Extended Anatomical™Silver Curvilinear Silicone Implant

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

FDA product codes

CodeNameDevices
FWPProsthesis, Chin, Internal555
FWPPROSTHESIS, CHIN, INTERNAL37
LZKImplant, Malar13
MNFImplant, Temporal2

GMDN & GCC registration

  • GMDN code 35261 · implantable
  • Single‑use 100% · sterile 57% · Rx‑only 100% · 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

Height (Millimeter) · 19Length (Millimeter) · 14Width (Millimeter) · 13

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

How many chin prosthesis products are registered in the US?

568 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Chin prosthesis", from 6 companies. The largest labeler is Implantech Associates, Inc. with 45% of records.

Which FDA product codes apply?

FWP (Prosthesis, Chin, Internal), FWP (PROSTHESIS, CHIN, INTERNAL), LZK (Implant, Malar), MNF (Implant, Temporal)

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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