Consulting Wallah › Device Explorer › Dental › Resin dental inlay
Device Explorer · FDA GUDID · GMDN 38649

Resin dental inlay

A custom-made dental restoration made of resin-based material that is bonded within the center of a tooth (intracoronal) typically to serve as a well-fitting, long-lasting alternative to dental fillings for tooth decay or similar damage. It is fabricated indir

US‑registered devices285in commercial distribution
Companies6labelers on GUDID
Single‑use78%of device records
Sterile0%labelled sterile
Prescription99%Rx‑only share
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Share of device records

3M Company11139%
Dent4You Ag9032%
Coltène/Whaledent Ag5820%
3M Deutschland Gmbh248%
Beijing Yingguan Dental Technology Co., Ltd.10%
Patterson Dental Supply, Inc.10%

Top labelers

CompanyDevicesShare
3M Company11139%
Dent4You Ag9032%
Coltène/Whaledent Ag5820%
3M Deutschland Gmbh248%
Beijing Yingguan Dental Technology Co., Ltd.10%
Patterson Dental Supply, Inc.10%

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

Brand names on the register (sample)

Resin InlayPatterson®Lava™Paradigm™Brilliant CriosBRILLIANT CriosTetric CAD

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

FDA product codes

CodeNameDevices
EBFMATERIAL, TOOTH SHADE, RESIN190
EBFMaterial, Tooth Shade, Resin148
KLEAgent, Tooth Bonding, Resin2
NSMRestoration, Resin1

GMDN & GCC registration

  • GMDN code 38649 · non‑implantable
  • Single‑use 78% · sterile 0% · Rx‑only 99% · 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 resin dental inlay products are registered in the US?

285 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Resin dental inlay", from 6 companies. The largest labeler is 3M Company with 39% of records.

Which FDA product codes apply?

EBF (MATERIAL, TOOTH SHADE, RESIN), EBF (Material, Tooth Shade, Resin), KLE (Agent, Tooth Bonding, Resin), NSM (Restoration, Resin)

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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