Consulting Wallah › Device Explorer › Orthopaedic implants › Facial mandibular prosthesis
Device Explorer · FDA GUDID · GMDN 16047

Facial mandibular prosthesis

A sterile implantable device intended to be used in the functional reconstruction of non-joint mandibular (lower jaw) deficits. It is made of metal and/or polymeric materials.

US‑registered devices72in commercial distribution
Companies1labelers on GUDID
Single‑use100%of device records
Sterile47%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Implantech Associates, Inc.72100%

Top labelers

CompanyDevicesShare
Implantech Associates, Inc.72100%

Company = labeler of record on GUDID. 1 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Widening Mandibular Angle™ SizersWidening Mandibular Angle™Vertical Mandibular Angle™ SizersVertical Mandibular Angle™Lateral Mandibular Angle™ SizersPosterior Mandibular Angle™Lateral Mandibular Angle™Lateral Mandibular Angle™Conform Mandibular Angle™ SizersConform Mandibular Angle™

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, Internal83
LZKImplant, Malar1

GMDN & GCC registration

  • GMDN code 16047 · implantable
  • Single‑use 100% · sterile 47% · 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

No structured size data on the register.

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

How many facial mandibular prosthesis products are registered in the US?

72 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Facial mandibular prosthesis", from 1 companies. The largest labeler is Implantech Associates, Inc. with 100% of records.

Which FDA product codes apply?

FWP (Prosthesis, Chin, Internal), LZK (Implant, Malar)

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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