Consulting Wallah › Device Explorer › Dental › Overdenture
Device Explorer · FDA GUDID · GMDN 38590

Overdenture

A custom-made, removable, artificial replacement for some or all teeth in the lower or upper jaw (mandible or maxilla) that is retained in the mouth with precision dental attachments. The attachments can be placed in retained tooth roots or dental implants.

US‑registered devices85in commercial distribution
Companies2labelers on GUDID
Single‑use100%of device records
Sterile0%labelled sterile
Prescription1%Rx‑only share
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Share of device records

Soadco, S.L.8499%
Preat Corporation11%

Top labelers

CompanyDevicesShare
Soadco, S.L.8499%
Preat Corporation11%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Preci-ClixKLOCKNER

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, endosseous84
EGGATTACHMENT, PRECISION, ALL1

GMDN & GCC registration

  • GMDN code 38590 · non‑implantable
  • Single‑use 100% · sterile 0% · Rx‑only 1% · 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 overdenture products are registered in the US?

85 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Overdenture", from 2 companies. The largest labeler is Soadco, S.L. with 99% of records.

Which FDA product codes apply?

NHA (Abutment, implant, dental, endosseous), EGG (ATTACHMENT, PRECISION, ALL)

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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