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Device Explorer · FDA GUDID · GMDN 44887

Dental osteotome

A hand-held, dental, surgical instrument used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. It is hand-held by the dentist who will use a surgical mallet or hammer to manually impart an

US‑registered devices1,917in commercial distribution
Companies54labelers on GUDID
Single‑use1%of device records
Sterile2%labelled sterile
Prescription69%Rx‑only share
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Share of device records

W.H. Holden, Inc.35519%
Bmt Medizintechnik Gmbh1669%
Suncoast Dental, Inc1166%
Avalign Technologies, Inc.1005%
Devemed Gmbh945%
Kls-Martin L.P.895%
Salvin Dental Specialties, Llc694%
Schobell Industrial Ltda653%

Top labelers

CompanyDevicesShare
W.H. Holden, Inc.35519%
Bmt Medizintechnik Gmbh1669%
Suncoast Dental, Inc1166%
Avalign Technologies, Inc.1005%
Devemed Gmbh945%
Kls-Martin L.P.895%
Salvin Dental Specialties, Llc694%
Schobell Industrial Ltda653%
A. Titan Instruments, Inc.613%
Ace Surgical Supply Co., Inc.593%
Storz Am Mark Gmbh573%
Altatec Gmbh523%

Company = labeler of record on GUDID. 54 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

FRIOS®XiVE®ANKYLOS®PaltopOsteotomOsteotome HandleOsteotome Insert 3.65mmDOsteotome Insert 3.25mmDOsteotome Insert 2.8mmDOsteotome Insert 2.0mmDNABISSBMT Medizintechnik GmbHKOHDENTSCREW-LINE OsteotomeSCREW-LINE Osteotomy set

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

FDA product codes

CodeNameDevices
EMMCHISEL, OSTEOTOME, SURGICAL630
GFIOSTEOTOME, MANUAL385
EMMChisel, Osteotome, Surgical339
NDPAccessories, Implant, Dental, Endosseous97
DZNInstruments, Dental Hand76
DZNINSTRUMENTS, DENTAL HAND75

GMDN & GCC registration

  • GMDN code 44887 · non‑implantable
  • Single‑use 1% · sterile 2% · Rx‑only 69% · 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

Outer Diameter (Millimeter) · 44Length (Inch) · 28

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

How many dental osteotome products are registered in the US?

1,917 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental osteotome", from 54 companies. The largest labeler is W.H. Holden, Inc. with 19% of records.

Which FDA product codes apply?

EMM (CHISEL, OSTEOTOME, SURGICAL), GFI (OSTEOTOME, MANUAL), EMM (Chisel, Osteotome, Surgical), NDP (Accessories, Implant, Dental, Endosseous)

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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