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Device Explorer · FDA GUDID · GMDN 16480

Dental elevator, tooth/root

A hand-held, manual, dental surgical instrument intended to be used as a lever during the extraction of a tooth or retained roots. It is typically a one-piece instrument with a strong but slender blade at the distal working end, or it may be double-ended with

US‑registered devices4,591in commercial distribution
Companies62labelers on GUDID
Single‑use1%of device records
Sterile1%labelled sterile
Prescription41%Rx‑only share
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Share of device records

W.H. Holden, Inc.45410%
Melpex Beauty Instruments4369%
Power Dental U.S.A. Inc.3728%
Zoll-Dental3688%
Hu-Friedy Mfg. Co., Llc2676%
Devemed Gmbh2445%
Helmut Zepf Medizintechnik Gmbh2395%
Kohler Medizintechnik Gmbh1894%

Top labelers

CompanyDevicesShare
W.H. Holden, Inc.45410%
Melpex Beauty Instruments4369%
Power Dental U.S.A. Inc.3728%
Zoll-Dental3688%
Hu-Friedy Mfg. Co., Llc2676%
Devemed Gmbh2445%
Helmut Zepf Medizintechnik Gmbh2395%
Kohler Medizintechnik Gmbh1894%
Salvin Dental Specialties, Llc1804%
Bmt Medizintechnik Gmbh1543%
Kls-Martin L.P.1473%
Surgical Direct, Inc.1092%

Company = labeler of record on GUDID. 62 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

FRIOS®CORONAflex 2005LMDentalInstrapacNABMT Medizintechnik GmbHKOHDENTSCHWERTReicodentdevemedERGOPLANTMediconAESCULAPPRODONT-HOLLIGERDarby Dental Supply, LLCBOSS Instruments

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

FDA product codes

CodeNameDevices
EMJELEVATOR, SURGICAL, DENTAL2,425
EMJElevator, Surgical, Dental1,437
GEGELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY429
DZNINSTRUMENTS, DENTAL HAND90
EMGForceps, Tooth Extractor, Surgical70
EIXPROBE, PERIODONTIC67

GMDN & GCC registration

  • GMDN code 16480 · non‑implantable
  • Single‑use 1% · sterile 1% · Rx‑only 41% · 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

Length (Inch) · 500Length (Millimeter) · 404Length (Centimeter) · 61Width (Millimeter) · 4

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

How many dental elevator, tooth/root products are registered in the US?

4,591 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental elevator, tooth/root", from 62 companies. The largest labeler is W.H. Holden, Inc. with 10% of records.

Which FDA product codes apply?

EMJ (ELEVATOR, SURGICAL, DENTAL), EMJ (Elevator, Surgical, Dental), GEG (ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY), 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.

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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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