FDA.reportPublic FDA data

Tatum Surgical-Osteotome

Primary DI
00083208040153
Brand
Tatum Surgical-Osteotome
Company
Suncoast Dental, Inc
Model
Osteotome Tapered 4.0 x 15 Straight
Catalog number
Osteotome Tapered 4.0 x 15 Straight
Device description
Osteotome, Tapered 4.0 x 15, Straight (Red)
Published
2020-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EMMChisel, Osteotome, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMMChisel, Osteotome, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00083208040153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00083208040153000832080401530832080401530083208040153

GMDN Terms#

Term, Definition table
TermDefinition
Dental osteotomeA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
727-536-4880tatumcompliance@gmail.com

Regulatory Flags#

DUNS number
078352849
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00083208003332Universal Screw Removal KitUniversal Screw Removal KitUniversal Screw Removal Kit2025-09-29
00083208163333Tatum EZ-Flex Periotome KitTatum EZ-Flex Periotome KitTatum EZ-Flex Periotome Kit2025-09-29
00083208191121Tatum Sinus Instrument Kit Tatum Sinus KitTatum Sinus Kit2024-09-25
00083208162220Tatum EZ Out Periotome E KitTatum EZ Out Periotome E KitTatum EZ Out Periotome E Kit2024-07-30
00083208135002DDP Dental MirrorDental MirrorDental Mirror2024-01-30
00083208136702DDP Extraction ForcepsForceps (67-A)Forceps (67-A)2024-01-30
00083208452215Tatum Surgical IP Press Fit AbutmentIP-PN-4.5 x 2 (CB) AbutmentIP-PN-4.5 x 2 (CB)2021-06-04
00083208453212Tatum Surgical IP Press Fit AbutmentIP-PN-4.5 x 3 (CB) AbutmentIP-PN-4.5 x 3 (CB)2021-06-04
00083208454219Tatum Surgical IP Press Fit AbutmentIP-PN-4.5 x 4 (CB) AbutmentIP-PN-4.5 x 4 (CB)2021-06-04
00083208455216Tatum Surgical IP Press Fit AbutmentIP-PN-4.5 x 5 (CB) AbutmentIP-PN-4.5 x 5 (CB)2021-06-04
00083208456213Tatum Surgical IP Press Fit AbutmentIP-PN-4.5 x 6 (CB) AbutmentIP-PN-4.5 x 6 (CB)2021-06-04
00083208502217Tatum Surgical IP Press Fit AbutmentIP-PN-5.0 x 2 (CB) AbutmentIP-PN-5.0 x 2 (CB)2021-06-04
00083208503214Tatum Surgical IP Press Fit AbutmentIP-PN-5.0 x 3 (CB) AbutmentIP-PN-5.0 x 3 (CB)2021-06-04
00083208504211Tatum Surgical IP Press Fit AbutmentIP-PN-5.0 x 4 (CB) AbutmentIP-PN-5.0 x 4 (CB)2021-06-04
00083208505218Tatum Surgical IP Press Fit AbutmentIP-PN-5.0 x 5 (CB) AbutmentIP-PN-5.0 x 5 (CB)2021-06-04
00083208506215Tatum Surgical IP Press Fit AbutmentIP-PN-5.0 x 6 (CB) AbutmentIP-PN-5.0 x 6 (CB)2021-06-04
00083208130526DDP Depth GaugeDepth GaugeDepth Gauge2022-10-19
00083208130427Zoll Scalpel Handle RoundScalpel Handle Round Z-4206 XLScalpel Handle Round2022-08-08
00083208131004DDP Extraction Forceps Forceps (1-A)Forceps (1-A)2022-06-30
00083208131509DDP Extraction Forceps Forceps (150-A)Forceps (150-A)2022-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251436931086KOHLERKohler Medizintechnik GmbHEMM2026-03-12
00841013120572Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMM2026-01-06
00841013120589Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMM2026-01-06
00841013120596Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMM2026-01-06
D9282001491H0OSTEOTOME, 7", 4mm SLIGHT CURVE MARKINGS 12-9-6-3mm, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
D9282001492H0OSTEOTOME, 7", 4mm, STRONG CURVE, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
D9282001493H0OSTEOTOME, 7", 4mm, OFFSET, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
D928200149H0OSTEOTOME, 7", 4mm STRAIGHT, MARKINGS 12-9-6-3mm, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
D9282001501H0OSTEOTOME, 7", 6mm, SLIGHT CURVE, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
D9282001502H0OSTEOTOME, 7", 6mm, STRONG CURVE, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
D9282001503H0OSTEOTOME, 7", 6mm, OFFSET, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
D928200150H0OSTEOTOME, 7", 6mm, STRAIGHT, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
00841336106260Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMM2025-11-11
00190776401306MillenniumAvalign Technologies, Inc.EMM2025-06-10
D92820029090BURTON PTERYGOID OSTEOTOME 9MMW.H. Holden, Inc.EMM2025-05-21
00190776394646MillenniumAvalign Technologies, Inc.EMM2025-05-07
G586NS38796080NOVOSURGICALNOVO SURGICAL, INC.EMM2025-05-02
00194613108656MSI Precision Specialty InstrumentsMed Saver, Inc.EMM2025-03-21
D928105382010BONE CHISEL 2.5MM, 6" S/EW.H. Holden, Inc.EMM2025-03-19
D928105382020BONE CHISEL 4MM, 6" S/EW.H. Holden, Inc.EMM2025-03-19
EZPF2474485HZU0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMM2025-03-07
EZPF4774831HZU0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMM2025-03-07
EZPF4774841HZU0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMM2025-03-07
D9281675060MINI-LEXER, OSTEOTOME 6mm, STRAIGHTW.H. Holden, Inc.EMM2024-12-18
D9281675080MINI-LEXER, OSTEOTOME 8mm, STRAIGHTW.H. Holden, Inc.EMM2024-12-18
D9281675100MINI-LEXER, OSTEOTOME 10mm STRAIGHTW.H. Holden, Inc.EMM2024-12-18
D9281676060MINI-LEXER, GOUGE 6mmW.H. Holden, Inc.EMM2024-12-18
D9281676080MINI-LEXER, GOUGE 8mmW.H. Holden, Inc.EMM2024-12-18
D9281676100MINI-LEXER, GOUGE 10mmW.H. Holden, Inc.EMM2024-12-18
D9281790900IDR KIT ACCORDING TO DR. ROSAW.H. Holden, Inc.EMM2024-12-18