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Device Explorer · FDA GUDID · GMDN 64422

Dental prosthesis removal instrument

A non-electric, hand-held dental instrument intended to be used to remove a permanent or temporary cemented dental prosthesis restoration (e.g., crown, denture, bridge) from a tooth or implant abutment; it is not a thermal detacher. It consists of a metallic i

US‑registered devices293in commercial distribution
Companies33labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription56%Rx‑only share
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Share of device records

Devemed Gmbh5619%
Helmut Zepf Medizintechnik Gmbh3412%
Zoll-Dental2910%
Arum Dentistry Co., Ltd.176%
Trate Llc165%
Terlain Enterprises, Inc.145%
Hager Worldwide, Inc.134%
Bmt Medizintechnik Gmbh124%

Top labelers

CompanyDevicesShare
Devemed Gmbh5619%
Helmut Zepf Medizintechnik Gmbh3412%
Zoll-Dental2910%
Arum Dentistry Co., Ltd.176%
Trate Llc165%
Terlain Enterprises, Inc.145%
Hager Worldwide, Inc.134%
Bmt Medizintechnik Gmbh124%
Storz Am Mark Gmbh124%
Karl Schumacher Dental, Llc114%
Salvin Dental Specialties, Llc103%
A. Schweickhardt Gmbh & Co. Kg83%

Company = labeler of record on GUDID. 33 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

CICADANABMT Medizintechnik GmbHMEDENTiKAKOHDENTSCHWERTdevemedReicodentAESCULAPPaul BandittTAUB - Trident - ECS (Expandable Crown Splitter)TAUB - Trident - IMPULSEKarl SchumacherTITAN IMPLANTS INCA. Titan InstrumentsSalvin Dental Specialties

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

FDA product codes

CodeNameDevices
EISREMOVER, CROWN121
EISRemover, Crown102
NDPAccessories, Implant, Dental, Endosseous38
DZNInstruments, Dental Hand12
EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL10
NDPAccessories, implant, dental, endosseous6

GMDN & GCC registration

  • GMDN code 64422 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 56% · 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 prosthesis removal instrument products are registered in the US?

293 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental prosthesis removal instrument", from 33 companies. The largest labeler is Devemed Gmbh with 19% of records.

Which FDA product codes apply?

EIS (REMOVER, CROWN), EIS (Remover, Crown), NDP (Accessories, Implant, Dental, Endosseous), DZN (Instruments, Dental Hand)

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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