Consulting Wallah › Device Explorer › Dental › Preformed complete denture
Device Explorer · FDA GUDID · GMDN 11172

Preformed complete denture

A prefabricated plastic plate designed to fit over an edentulous maxillary or mandibular alveolar ridge; an entire complement of artificial teeth from one arch is added to create a full denture. It is available in several standard sizes that can be contoured t

US‑registered devices4,392in commercial distribution
Companies5labelers on GUDID
Single‑use4%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Merz Dental Gmbh4,20896%
Good Fit Technologies, Llc1684%
Stoneglass Dental Laboratory Pty Ltd140%
Shenzhen Jiahong Dental Technology Co.,Ltd.10%
Sonrisa, Llc10%

Top labelers

CompanyDevicesShare
Merz Dental Gmbh4,20896%
Good Fit Technologies, Llc1684%
Stoneglass Dental Laboratory Pty Ltd140%
Shenzhen Jiahong Dental Technology Co.,Ltd.10%
Sonrisa, Llc10%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Jiahong dental labEasy DentureGood Fit Instant Denture SetupsGood Fit Instant OverdenturesBaltic Denture System BDLoad XPBaltic Denture System BDLoadBaltic Denture System BD LoadBaltic Denture System BDKEY PMMABaltic Denture System BDCreatorBaltic Denture System BD Key ConnectBaltic Denture System BD Key LockBaltic Denture System BD Key Plane / BD Key FinBaltic Denture System BD KeyBDS DemonstrationskofferBaltic Denture System BD CreatorBaltic Denture System BDStarterSet

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

FDA product codes

CodeNameDevices
EKODenture Preformed (Partially Prefabricated Denture)4,378
NSLDentures, Full14

GMDN & GCC registration

  • GMDN code 11172 · non‑implantable
  • Single‑use 4% · sterile 0% · Rx‑only 0% · 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 preformed complete denture products are registered in the US?

4,392 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Preformed complete denture", from 5 companies. The largest labeler is Merz Dental Gmbh with 96% of records.

Which FDA product codes apply?

EKO (Denture Preformed (Partially Prefabricated Denture)), NSL (Dentures, Full)

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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