Consulting Wallah › Device Explorer › Dental › Dental composite resin kit
Device Explorer · FDA GUDID · GMDN 62477

Dental composite resin kit

A collection of non-sterile substances intended for professional use during dental restoration and prosthesis installation/repair which includes composite resin material and additional materials to support restoration (e.g., etching solution, bonding agent, pr

US‑registered devices214in commercial distribution
Companies11labelers on GUDID
Single‑use48%of device records
Sterile0%labelled sterile
Prescription85%Rx‑only share
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Share of device records

Axiodent Inc.8640%
Kuraray Noritake Dental Inc.5425%
Hexa Dental2110%
Prevest Denpro Limited178%
3M Deutschland Gmbh147%
Selenbio Dental, Inc.94%
Bisco Inc.73%
Chameleon Dental Products, Inc31%

Top labelers

CompanyDevicesShare
Axiodent Inc.8640%
Kuraray Noritake Dental Inc.5425%
Hexa Dental2110%
Prevest Denpro Limited178%
3M Deutschland Gmbh147%
Selenbio Dental, Inc.94%
Bisco Inc.73%
Chameleon Dental Products, Inc31%
Kettenbach Gmbh & Co. Kg10%
D.S.I Dental Solutions Ltd10%
Henry Schein, Inc.10%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PANAVIA™ Veneer LCPANAVIA™ V5CLEARFIL™ SE BOND Restorative KitPANAVIA™ 21PANAVIA™ F 2.0 Complete KitPANAVIA™ F 2.0CoJet™ SandCoJet™ PrepRocatec™ SoftRocatec™ PlusRocatec™Visalys CemCoreFusion I SealFusion Core DC Flo and Fusion Bond DCMagma NTFusion Core DC Flo

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, Resin113
EMACement, Dental53
EBFMaterial, tooth shade, resin21
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL20
KLEAGENT, TOOTH BONDING, RESIN19
KXRAPPLICATOR, RESIN19

GMDN & GCC registration

  • GMDN code 62477 · non‑implantable
  • Single‑use 48% · sterile 0% · Rx‑only 85% · 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 dental composite resin kit products are registered in the US?

214 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental composite resin kit", from 11 companies. The largest labeler is Axiodent Inc. with 40% of records.

Which FDA product codes apply?

EBF (Material, Tooth Shade, Resin), EMA (Cement, Dental), EBF (Material, tooth shade, resin), EID (SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL)

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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