Consulting Wallah › Device Explorer › Dental › Manual non-rotary dental instrument handle
Device Explorer · FDA GUDID · GMDN 64304

Manual non-rotary dental instrument handle

A hand-held, manual device designed to hold and facilitate manipulation of a non-powered, non-rotary dental instrument (e.g., endodontic file/rasp, implant extractor). It is designed to accept the patient-contact endpiece (not included) for ease of handling. T

US‑registered devices728in commercial distribution
Companies36labelers on GUDID
Single‑use9%of device records
Sterile0%labelled sterile
Prescription82%Rx‑only share
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Share of device records

Hager & Meisinger Gesellschaft Mit Beschränkter Haftung40756%
Dentium Co., Ltd.7911%
Osstem Implant Co., Ltd.476%
American Eagle Instruments, Inc.203%
Nordent Manufacturing Inc182%
Biohorizons Implant Systems, Inc162%
Medentika Gmbh152%
Premium Plus International Limited152%

Top labelers

CompanyDevicesShare
Hager & Meisinger Gesellschaft Mit Beschränkter Haftung40756%
Dentium Co., Ltd.7911%
Osstem Implant Co., Ltd.476%
American Eagle Instruments, Inc.203%
Nordent Manufacturing Inc182%
Biohorizons Implant Systems, Inc162%
Medentika Gmbh152%
Premium Plus International Limited152%
Nusmile, Ltd.101%
American Medicals101%
B& L Biotech, Inc.81%
Bioclear Matrix Systems71%

Company = labeler of record on GUDID. 36 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DS ImplantsProfinMulti Unit HolderMulti Angled Abutment Carrier,MiniMulti Angled Abutment Carrier,RegularNAMedentikaMEDENTiKAKONTACTn/aOKTAGON®Bone ManagementInstrument SetBioclear InstrumentGentle Hand-Bur SystemsOHIO FORGE MIRROR HANDLE - OCTAGONAL WITH RULER

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

FDA product codes

CodeNameDevices
EJLBUR, DENTAL182
NDPAccessories, implant, dental, endosseous157
NDPAccessories, Implant, Dental, Endosseous139
GFFBUR, SURGICAL, GENERAL & PLASTIC SURGERY58
DZNINSTRUMENTS, DENTAL HAND47
EJBHandle, Instrument, Dental33

GMDN & GCC registration

  • GMDN code 64304 · non‑implantable
  • Single‑use 9% · sterile 0% · Rx‑only 82% · OTC 2%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Millimeter) · 75Length (Inch) · 18Height (Millimeter) · 8Outer Diameter (Millimeter) · 3Balloon Diameter (Millimeter) · 1

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

How many manual non-rotary dental instrument handle products are registered in the US?

728 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Manual non-rotary dental instrument handle", from 36 companies. The largest labeler is Hager & Meisinger Gesellschaft Mit Beschränkter Haftung with 56% of records.

Which FDA product codes apply?

EJL (BUR, DENTAL), NDP (Accessories, implant, dental, endosseous), NDP (Accessories, Implant, Dental, Endosseous), GFF (BUR, SURGICAL, GENERAL & PLASTIC SURGERY)

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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