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Device Explorer · FDA GUDID · GMDN 62817

Dental appliance fabrication material, combination-material

A dental material made of a combination of metal, ceramic, and/or synthetic polymer [e.g., polyethylene (PE)] intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used t

US‑registered devices856in commercial distribution
Companies16labelers on GUDID
Single‑use87%of device records
Sterile0%labelled sterile
Prescription77%Rx‑only share
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Share of device records

Liaoning Rachcera Material Technology Co.,Ltd.30836%
Chengdu Besmile Medical Technology Co., Ltd.19222%
Vericom Co., Ltd.12414%
Ivoclar Vivadent Aktiengesellschaft465%
Deltamed Gmbh415%
Edelweiss Dentistry Products Gmbh354%
Changsha Honchon Technology Co., Ltd223%
Kettenbach Gmbh & Co. Kg182%

Top labelers

CompanyDevicesShare
Liaoning Rachcera Material Technology Co.,Ltd.30836%
Chengdu Besmile Medical Technology Co., Ltd.19222%
Vericom Co., Ltd.12414%
Ivoclar Vivadent Aktiengesellschaft465%
Deltamed Gmbh415%
Edelweiss Dentistry Products Gmbh354%
Changsha Honchon Technology Co., Ltd223%
Kettenbach Gmbh & Co. Kg182%
Bredent Gmbh & Co. Kg172%
Zhejiang Zahndent Biotechnology Co.,Ltd121%
Zirdent New Material Co.,Ltd121%
Hunan Vsmile Biotechnology Co.,Ltd121%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Dental Lithium Disilicate Glass CeramicDental Zirconia Blank & Dental Zirconia Pre-ShadDental Zirconia BlankDental Glass Ceramics BlocksZirdent Dental Zirconia Blank & Dental Zirconia Vsmilehappyzir Dental Zirconia Blank &Dental ZirDental Glass CeramicsRS VIVO C&B UltimatePRO Resins Arch XPRO Resins Crown X3Delta UNlimited3Delta CrownbreCAM.HIPCSHOFU BLOCK HCVisalys BioCeramic BlockTetric

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

FDA product codes

CodeNameDevices
EIHPowder, Porcelain569
EBFMaterial, Tooth Shade, Resin218
EBFMaterial, tooth shade, resin49
EBFMATERIAL, TOOTH SHADE, RESIN31
ELMDenture, plastic, teeth14
EBIResin, Denture, Relining, Repairing, Rebasing13

GMDN & GCC registration

  • GMDN code 62817 · non‑implantable
  • Single‑use 87% · sterile 0% · Rx‑only 77% · 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

Height (Millimeter) · 17Outer Diameter (Millimeter) · 17

Use these as the dimensions to specify in a tender line.

How many dental appliance fabrication material, combination-material products are registered in the US?

856 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental appliance fabrication material, combination-material", from 16 companies. The largest labeler is Liaoning Rachcera Material Technology Co.,Ltd. with 36% of records.

Which FDA product codes apply?

EIH (Powder, Porcelain), EBF (Material, Tooth Shade, Resin), EBF (Material, tooth shade, resin), EBF (MATERIAL, TOOTH SHADE, 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.

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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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