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Device Explorer · FDA GUDID · GMDN 62110

Dental prosthesis dye

A colouring intended to be used to stain a dental prosthesis (e.g., crown, bridge) before insertion in the patient to achieve a colour to match existing dentition. It is a mixture of inorganic chemicals typically used during the prosthesis manufacturing proces

US‑registered devices762in commercial distribution
Companies9labelers on GUDID
Single‑use88%of device records
Sterile0%labelled sterile
Prescription29%Rx‑only share
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Share of device records

Aidite (Qinhuangdao) Technology Co., Ltd.38551%
Dental Direkt Gmbh13718%
Shenzhen Xiangtong Co., Ltd537%
Talladium, Inc.496%
Vatech Mcis Co., Ltd436%
Liaoning Upcera Co.,Ltd.375%
Henry Schein, Inc.375%
Dongguan Xiangtong Co.,Ltd192%

Top labelers

CompanyDevicesShare
Aidite (Qinhuangdao) Technology Co., Ltd.38551%
Dental Direkt Gmbh13718%
Shenzhen Xiangtong Co., Ltd537%
Talladium, Inc.496%
Vatech Mcis Co., Ltd436%
Liaoning Upcera Co.,Ltd.375%
Henry Schein, Inc.375%
Dongguan Xiangtong Co.,Ltd192%
Roydent Dental Products Inc20%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AiditeXTCERAXT stain/glazeColoring LiquidUPCERA COLORING LIQUID (I AND II )Coloring Liquid T0DD Pro Shade ZDD Pro Shade CDD Basic ShadeDD Art ElementsDD Art ElementsRoydentColor LiquidOFA Coloring LiquidLuminesse HF Trial KitLuminesse Universal Glaze Powder

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

FDA product codes

CodeNameDevices
EIHPowder, Porcelain786
EIHPOWDER, PORCELAIN37
LFCDEVICE, CARIES DETECTION2

GMDN & GCC registration

  • GMDN code 62110 · non‑implantable
  • Single‑use 88% · sterile 0% · Rx‑only 29% · 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

Total Volume (Milliliter) · 224

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

How many dental prosthesis dye products are registered in the US?

762 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental prosthesis dye", from 9 companies. The largest labeler is Aidite (Qinhuangdao) Technology Co., Ltd. with 51% of records.

Which FDA product codes apply?

EIH (Powder, Porcelain), EIH (POWDER, PORCELAIN), LFC (DEVICE, CARIES DETECTION)

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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