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Device Explorer · FDA GUDID · GMDN 44886

Dental osteotome set

A collection of dental surgical osteotomes used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. This device typically contains osteotomes of varying sizes and shapes and a surgical mallet

US‑registered devices62in commercial distribution
Companies10labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription34%Rx‑only share
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Share of device records

W.H. Holden, Inc.3353%
Zimvie Us Corp Llc915%
Power Dental U.S.A. Inc.58%
Suncoast Dental, Inc58%
Dentin Implants Technologies Ltd23%
Paltop Advanced Dental Solutions Ltd23%
Oco Biomedical Inc23%
Institut Straumann Ag23%

Top labelers

CompanyDevicesShare
W.H. Holden, Inc.3353%
Zimvie Us Corp Llc915%
Power Dental U.S.A. Inc.58%
Suncoast Dental, Inc58%
Dentin Implants Technologies Ltd23%
Paltop Advanced Dental Solutions Ltd23%
Oco Biomedical Inc23%
Institut Straumann Ag23%
Sic Invent Ag12%
Bicon, Llc12%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

OSTEOTOMES KITPaltopSIC invent Dental Implant SystemsPower Dental U.S.A., Inc.GRAFT PACKER #3 STERNLIEB, ROUND 3.3mm / 4.0mm CGRAFT PACKER #2 STERNLIEB, ROUND 2.8mm RECTANGLEGRAFT PACKER STERNLIEB, ROUND 1.3 / 2.8mm CH D/ESINUS INSTRUMENT #9 CH S/ESINUS INSTRUMENT #9 HD D/ESINUS INSTRUMENT #9 CH D/EBOSACK BONE CARRIERSINUS INSTRUMENT GRAFT PACKER #8 1.3MM / 2.8MM SINUS INSTRUMENT #8 SM GRAFT 1.3 / 2.8mm HD D/ESINUS INST #8 SM GRAFT 1.3 / 2.8mm CH D/ESINUS INSTRUMENT #7 HD D/ESINUS INSTRUMENT #7 CH D/E

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

FDA product codes

CodeNameDevices
GFIOSTEOTOME, MANUAL35
NDPACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS9
EMMChisel, Osteotome, Surgical6
NDPAccessories, implant, dental, endosseous5
DZNInstruments, Dental Hand4
NDPAccessories, Implant, Dental, Endosseous3

GMDN & GCC registration

  • GMDN code 44886 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 34% · 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 osteotome set products are registered in the US?

62 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental osteotome set", from 10 companies. The largest labeler is W.H. Holden, Inc. with 53% of records.

Which FDA product codes apply?

GFI (OSTEOTOME, MANUAL), NDP (ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS), 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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