Tatum Surgical-Osteotome

Osteotome, Offset, Bone Scalpel blade 5.0mm Blue

Registry build 21.09.26
4manufacturers in China registered for this device type
108catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (1), Shandong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code EMM
Manufacturer City Province Registered as Device types
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Pengbo (Shenzhen) Medical Technology Co., Ltd. Shenzhen Guangdong Manufacturer 6

Record

Regulatory record for Tatum Surgical-Osteotome
Listed by Suncoast Dental, Inc., United States
FDA product code EMM
Device type Chisel, Osteotome, Surgical
Device class Class 1
Regulation 21 CFR 872.4565
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2020-04-03

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Tatum Surgical-Osteotome
Catalogue number Size Status
Osteotome Tapered 4.0 x 15 Offset Diameter of head 4.0mm In distribution
OsteotomeZ RB 3.5 Diameter of Head 3.5mm In distribution
Osteotome Tapered 4.0 x 18 Straight Diameter of head 4.0mm In distribution
Osteotome Tapered 3.0 x 21 Offset Diameter of head 3.0mm In distribution
Osteotome Tapered 4.5 x 15 Offset Diameter of head 4.5mm In distribution
OsteotomeZ D3 7.5 Width of Blade 7.5mm In distribution
OsteotomeZ RP 4.0 Diameter of Head 4.0mm In distribution
OsteotomeZ RT 5.0 Diameter of Head 5.0mm In distribution
OsteotomeZ RP 3.5 Diameter of Head 3.5mm In distribution
OsteoZ Offset RP 4.0 Diameter of head 4.0mm In distribution
Osteotome Tapered 4.0 x 12 Offset Diameter of head 4.0mm In distribution
OsteotomeZ BB 4.0 Width of Blade 4.0mm In distribution
Osteotome Tapered 7.0 x 18 Offset Diameter of head 7.0mm In distribution
Osteotome Tapered 4.0 x 15 Straight Diameter of head 4.0mm In distribution
OsteoZ Offset RT 3.0N Diameter of head 3.0mm In distribution
OsteoZ Offset BS 5.0 Width of blade 5.0mm In distribution
OsteoZ Offset BB 7.5 Width of blade 7.5mm In distribution
Osteotome Tapered 3.0×18 Straight Diameter of head 3.0mm In distribution
OsteotomeZ RB 4.5 Diameter of Head 4.5mm In distribution
Osteotome Tapered 8.0 x 18 Offset Diameter of head 8.0mm In distribution
Osteotome Tapered 6.0 x 12 Offset Diameter of head 6.0mm In distribution
Osteotome Tapered 6.0 x 21 Offset Diameter of head 6.0mm In distribution
OsteoZ Offset RP 5.5 Diameter of head 5.5mm In distribution
Osteotome Tapered 4.0 x 18 Offset Diameter of head 4.0mm In distribution
Osteotome Tapered 3.5 x 18 Straight Diameter of head 3.5mm In distribution
OsteotomeZ RP 3.0 Diameter of Head 3.0mm In distribution
Osteotome Tapered 4.5 x 21 Offset Diameter of head 4.5mm In distribution
Osteotome Tapered 5.0 x 21 Straight Diameter of head 5.0mm In distribution
OsteoZ Offset RB 3.0 Diameter of head 3.0mm In distribution
OsteotomeZ RT 3.0 Diameter of Head 3.0mm In distribution
OsteoZ Offset BB 10.0 Width of blade 10.0mm In distribution
Osteotome Tapered 6.0 x 18 Offset Diameter of head 6.0mm In distribution
OsteotomeZ D1 4.0 Width of Blade 4.0mm In distribution
OsteoZ Offset D4 10.0 Width of blade 10.0mm In distribution
OsteotomeZ BS 6.0 Width of Blade 6.0mm In distribution
OsteoZ Offset RP 3.0 Diameter of head 3.0mm In distribution
Osteotome Tapered 3.5 x 21 Offset Diameter of head 3.5mm In distribution
Osteotome Tapered 3.0 x 18 Offset Diameter of head 3.0mm In distribution
Osteotome Tapered 4.0 x 12 Straight Diameter of head 4.0mm In distribution
Osteotome Tapered 4.5 x 12 Offset Diameter of head 4.5mm In distribution
Osteotome Tapered 3.0 x 15 Offset Diameter of head 3.0mm In distribution
Osteotome Tapered 3.5 x 21 Straight Diameter of head 3.5mm In distribution
Osteotome Tapered 8.0 x 15 Offset Diameter of head 8.0mm In distribution
Osteotome Tapered 5.0 x 15 Straight Diameter of head 5.0mm In distribution
Osteotome Tapered 3.0×21 Straight Diameter of head 3.0mm In distribution
Osteotome Tapered 7.0 x 15 Offset Diameter of head 7.0mm In distribution
OsteoZ Offset RB 5.0 Diameter of head 5.0mm In distribution
OsteoZ Offset RP 5.0 Diameter of head 5.0mm In distribution
Osteotome Tapered 5.0 x 18 Straight Diameter of head 5.0mm In distribution
OsteotomeZ RB 5.0 Diameter of Head 5.0mm In distribution
OsteoZ Offset D1 4.0 Width of blade 4.0mm In distribution
OsteotomeZ BS 5.0 Width of Blade 5.0mm In distribution
OsteoZ Offset BB 4.0 Width of blade 4.0mm In distribution
Osteotome Tapered 6.0 x 18 Straight Diameter of head 6.0mm In distribution
OsteotomeZ RP 6.0 Diameter of Head 6.0mm In distribution
OsteoZ Offset RT 4.0N Diameter of head 4.0mm In distribution
OsteotomeZ BS 4.0 Width of Blade 4.0mm In distribution
OsteotomeZ BB 7.5 Width of Blade 7.5mm In distribution
Osteotome Tapered 7.0 x 12 Offset Diameter of head 7.0mm In distribution
Osteotome Tapered 3.0 x 23 Offset Diameter of head 3.0mm In distribution
Osteotome Tapered 4.5 x 18 Offset Diameter of head 4.5mm In distribution
Osteotome Tapered 3.5 x 15 Straight Diameter of head 3.5mm In distribution
Osteotome Tapered 4.5 x 15 Straight Diameter of head 4.5mm In distribution
OsteotomeZ D4 10.0 Width of Blade 10.0mm In distribution
OsteoZ Offset RB 4.0 Diameter of head 4.0mm In distribution
OsteotomeZ RT 4.0 Diameter of Head 4.0mm In distribution
OsteoZ Offset D2 5.5 Width of blade 5.5mm In distribution
OsteotomeZ RB 6.0 Diameter of Head 6.0mm In distribution
Osteotome Tapered 4.5 x 18 Straight Diameter of head 4.5mm In distribution
OsteoZ Offset RP 4.5 Diameter of head 4.5mm In distribution
Osteotome Tapered 3.5 x 18 Offset Diameter of head 3.5mm In distribution
OsteotomeZ D2 5.5 Width of Blade 5.5mm In distribution
OsteoZ Offset RB 3.5 Diameter of head 3.5mm In distribution
Osteotome Tapered 8.0 x 12 Offset Diameter of head 8.0mm In distribution
Osteotome Tapered 5.0 x 15 Offset Diameter of head 5.0mm In distribution
Osteotome Tapered 6.0 x 21 Straight Diameter of head 6.0mm In distribution
Osteotome Tapered 4.5 x 21 Straight Diameter of head 4.5mm In distribution
OsteoZ Offset RP 3.5 Diameter of head 3.5mm In distribution
Osteotome Tapered 4.0 x 21 Offset Diameter of head 4.0mm In distribution
OsteoZ Offset RB 4.5 Diameter of head 4.5mm In distribution
Osteotome Tapered 5.0 x 12 Straight Diameter of head 5.0mm In distribution
Osteotome Tapered 4.5 x 12 Straight Diameter of head 4.5mm In distribution
Osteotome Tapered 6.0 x 15 Straight Diameter of head 6.0mm In distribution
Osteotome Tapered 5.0 x 21 Offset Diameter of head 5.0mm In distribution
Osteotome Tapered 4.0 x 21 Straight Diameter of head 4.0mm In distribution
OsteotomeZ BB 5.5 Width of Blade 5.5mm In distribution
Osteotome Tapered 3.0×15 Straight Diameter of head 3.0mm In distribution
OsteotomeZ RB 4.0 Diameter of Head 4.0mm In distribution
OsteoZ Offset BB 5.5 Width of blade 5.5mm In distribution
Osteotome Tapered 3.5 x 15 Offset Diameter of head 3.5mm In distribution
OsteoZ Offset BS 4.0 Width of blade 4.0mm In distribution
OsteotomeZ BB 10.0 Width of Blade 10.0mm In distribution
OsteotomeZ RB 3.0 Diameter of Head 3.0mm In distribution
OsteotomeZ RT 2.0 Diameter of Head 2.0mm In distribution
Osteotome Tapered 5.0 x 18 Offset Diameter of head 5.0mm In distribution
OsteoZ Offset RT 2.0N Diameter of head 2.0mm In distribution
OsteoZ Offset D3 7.5 Width of blade 7.5mm In distribution
OsteoZ Offset RB 6.0 Diameter of head 6.0mm In distribution
Osteotome Tapered 6.0 x 12 Straight Diameter of head 6.0mm In distribution
Osteotome Tapered 3.5 x 12 Offset Diameter of head 3.5mm In distribution
OsteotomeZ RP 5.0 Diameter of Head 5.0mm In distribution
OsteoZ Offset BS 6.0 Width of blade 6.0mm In distribution
Osteotome Tapered 3.0×23 Straight Diameter of head 3.0mm In distribution
Osteotome Tapered 6.0 x 15 Offset Diameter of head 6.0mm In distribution
OsteotomeZ RP 4.5 Diameter of Head 4.5mm In distribution
OsteoZ Offset RT 5.0N Diameter of head 5.0mm In distribution
Osteotome Tapered 3.5 x 12 Straight Diameter of head 3.5mm In distribution
Osteotome Tapered 5.0 x 12 Offset Diameter of head 5.0mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Sklar® Sklar Corporation 482
gSource Gsource, LLC. 296
Helmut Zepf Helmut Zepf Medizintechnik Gmbh 101
Kohdent Kohler Medizintechnik GmbH 86
MSI Precision Specialty Instruments MED Saver, Inc. 78
ACE Ace Surgical Supply Co., Inc. 73
Osteotome KLS-Martin L.P. 70
Aesculap Aesculap AG 69
Salvin Dental Specialties Salvin Dental Specialties, LLC 64
Millennium Avalign Technologies, Inc. 63
devemed Devemed Gmbh 63
Schwert A. Schweickhardt Gmbh & Co. KG 54

Showing 12 of 283. All products under Chisel, Osteotome, Surgical

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

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