Consulting Wallah › Device Explorer › Dental › Intramucosal dental implant
Device Explorer · FDA GUDID · GMDN 42350

Intramucosal dental implant

A sterile device made of alloplastic materials intended to be surgically implanted into the soft-tissue lining of the oral cavity (intramucosal insert) to provide support and a means of retention for a dental prosthesis (typically removable dentures).

US‑registered devices129in commercial distribution
Companies3labelers on GUDID
Single‑use100%of device records
Sterile22%labelled sterile
Prescription26%Rx‑only share
ImplantableYesGMDN flag
ShareLinkedIn

Share of device records

Soadco, S.L.9674%
Leone Spa2922%
Dentsply Implants Manufacturing Gmbh43%

Top labelers

CompanyDevicesShare
Soadco, S.L.9674%
Leone Spa2922%
Dentsply Implants Manufacturing Gmbh43%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ASTRA TECH Implant System® EVKLOCKNERLEONE SPA

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, endosseous95
DZEImplant, Endosseous, Root-Form29
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM8
NDPAccessories, implant, dental, endosseous1

GMDN & GCC registration

  • GMDN code 42350 · implantable
  • Single‑use 100% · sterile 22% · Rx‑only 26% · 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 intramucosal dental implant products are registered in the US?

129 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Intramucosal dental implant", from 3 companies. The largest labeler is Soadco, S.L. with 74% of records.

Which FDA product codes apply?

NHA (Abutment, implant, dental, endosseous), DZE (Implant, Endosseous, Root-Form), DZE (IMPLANT, ENDOSSEOUS, ROOT-FORM), NDP (Accessories, implant, dental, endosseous)

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?

Add intramucosal dental implant to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

Request quotes for Intramucosal dental implant

Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.

Buying intramucosal dental implant for a hospital group?Free executive assessment: we benchmark your prices and tender structure against the Network.
Book the free assessment

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.

Get quotes →