Consulting Wallah › Device Explorer › Dental › Dental porcelain/ceramic restoration kit
Device Explorer · FDA GUDID · GMDN 44727

Dental porcelain/ceramic restoration kit

A collection of containers with different shades of porcelain (ceramic based material in powder form) intended to be used in prefabricated and custom-made dental restorations, e.g., artificial teeth on copings, crowns, or bridges. This kit is typically used in

US‑registered devices3,222in commercial distribution
Companies17labelers on GUDID
Single‑use74%of device records
Sterile0%labelled sterile
Prescription68%Rx‑only share
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Share of device records

Argen Corporation, The1,30541%
Nissin Metec China Co.,Ltd.50416%
Shofu Dental Corporation50416%
De Corematrix Co., Ltd.1886%
Aurident Inc1775%
Vita - Zahnfabrik H. Rauter Gesellschaft Mit Beschränkter Haftung & Co Kommanditgesellschaft1324%
Liaoning Upcera Co.,Ltd.1164%
Jensen Industries Inc.732%

Top labelers

CompanyDevicesShare
Argen Corporation, The1,30541%
Nissin Metec China Co.,Ltd.50416%
Shofu Dental Corporation50416%
De Corematrix Co., Ltd.1886%
Aurident Inc1775%
Vita - Zahnfabrik H. Rauter Gesellschaft Mit Beschränkter Haftung & Co Kommanditgesellschaft1324%
Liaoning Upcera Co.,Ltd.1164%
Jensen Industries Inc.732%
Pearson Dental Supplies, Inc.712%
Kerr Corporation672%
Upcera Dental America Inc.401%
Shenzhen Xiangtong Co., Ltd251%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DE corematrixXTCERANissin Dental Zirconia Blank & Dental Zirconia PGlaze pastePorcelain PowdersVINTAGE Art UniversalVINTAGE ART UNIV LIQUID 20MLVINTAGE PRO COLOR IND OPAQ DENTINVINTAGE PRO COLOR IND ENAMEL EFFECTVINTAGE PRO COLOR IND ENAMELVINTAGE PRO COLOR IND EFF/GUM/CERVViNTAGE PRO COLOR IND BODYVINTAGE PRO MARGIN SETVINTAGE PRO COLOR EFFECTS SETVINTAGE PRO ENAMAL EFFECTS SETVINTAGE PRO A3 PASTE OPAQUE SE

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

FDA product codes

CodeNameDevices
EIHPOWDER, PORCELAIN1,951
EIHPowder, Porcelain1,279
EBFMATERIAL, TOOTH SHADE, RESIN68
EBDCoating, Filling Material, Resin7
ELLTEETH, PORCELAIN6
EBGCROWN AND BRIDGE, TEMPORARY, RESIN1

GMDN & GCC registration

  • GMDN code 44727 · non‑implantable
  • Single‑use 74% · sterile 0% · Rx‑only 68% · 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

Weight (Gram) · 43Total Volume (Milliliter) · 18

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

How many dental porcelain/ceramic restoration kit products are registered in the US?

3,222 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental porcelain/ceramic restoration kit", from 17 companies. The largest labeler is Argen Corporation, The with 41% of records.

Which FDA product codes apply?

EIH (POWDER, PORCELAIN), EIH (Powder, Porcelain), EBF (MATERIAL, TOOTH SHADE, RESIN), EBD (Coating, Filling Material, 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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