Home GUDID D92810517038HFC0 OSTEOTOME NON-TAPERED - 3.8mm - CONCAVE HF MARKINGS 4-6-8-10-13-15
Primary DI D92810517038HFC0
Brand OSTEOTOME NON-TAPERED - 3.8mm - CONCAVE HF MARKINGS 4-6-8-10-13-15
Company W.H. Holden, Inc.
Model 10-5170-38HFC
Published 2023-10-10
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name GFI OSTEOTOME, MANUAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GFI Osteotome, Manual General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D92810517038HFC0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition 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 impacting force to the proximal end of the instrument. The device will have a straight or bayonet-shaped handle leading to a round or concave tip at the distal end, which may be marked with graduations to indicate depth differences. It is used for ridge expanding, bone condensing and sinus floor elevation procedures. This device will be made of high-grade stainless steel. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 183854322 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published D9282000201SUL0 SMITH SAGGITAL SPLITTER-MOD 20-0020-1-SUL 2026-05-27 D928105406HFDLC0 STAHR TUNNEL RETRACTOR HF D/E DLC 10-5406HFDLC 2026-03-18 D928105535DLC0 """OH"" ZYGOMA RETRACTOR DLC" 10-5535DLC 2026-03-18 D9284004001CH0 PERIO FILE SUGARMAN 1S D/E CH HANDLE SPECIAL DR SIN 40-0400-1CH 2026-03-18 D9284004002CH0 PERIO FILE SUGARMAN 2S D/E CH HANDLE SPECIAL DR SIN 40-0400-2CH 2026-03-18 D928400400CH0 PERIO FILE SUGARMAN 1S/2S D/E CH HANDLE 40-0400CH 2026-03-18 D928400400HD0 PERIO FILE SUGARMAN 1S/2S D/E HD HANDLE 40-0400HD 2026-03-18 D928400400HF0 PERIO FILE SUGARMAN 1S/2S D/E HF HANDLE 40-0400HF 2026-03-18 D928400435RD0 PERIO FILE SCHLUGER 9/10 D/E ROUND HANDLE 40-0435RD 2026-03-18 D9281051992HF0 SINUS INSTRUMENT #2 HF D/E 10-5199-2HF 2026-02-19 D928400527H0 POWERTOME S/E HF HANDLE 40-0527H 2026-01-27 D928106122R450 SUCTION TIP #2-REGULAR - 45DEG RIGHT GRIND ANGLE 10-6122-R45 2026-01-15 D9281059552HF570 CURETTE SINUS LARGE PADDLE SHARP, SMALL PADDLE DULL, D/E HANDFORM HANDLE LONG 10-5955-2HF57 2026-01-14 D928400101CH0 PERIO KNIFE GOLDMAN FOX 8 CH HANDLE 40-0101CH 2026-01-14 D928400102CH0 PERIO KNIFE GOLDMAN FOX 11 CH HANDLE 40-0102CH 2026-01-14 D928400102HF0 PERIO KNIFE GOLDMAN FOX 11 HF HANDLE 40-0102HF 2026-01-14 D928400102R0 PERIO KNIFE GOLDMAN FOX 11 ROUND HANDLE 40-0102R 2026-01-14 D9284001040 D9284001040 40-0104 2026-01-14 D928100600962DLC0 EXTRACTION FORCEPS #962 UPPER DLC 10-0600-962DLC 2026-01-06 D9281009301850 RONGEUR DOUBLE ACTION RUSKIN CURVED 18CM, 5MM 10-0930-18-5 2026-01-06
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