FDA.reportPublic FDA data

Tatum Surgical-Osteotome Kit

Primary DI
00083208002229
Brand
Tatum Surgical-Osteotome Kit
Company
Suncoast Dental, Inc
Model
Tatum Universal Offset Osteotome Kit
Catalog number
Osteotomez Offset 24
Device description
"Tatum Universal Offset Osteotome Kit designed for use in bone expansion: Includes 24 instruments and 2 Autoclaveable cassettes:Bone Scalpels (Blue) - BS4.0, 5.0 & 6.0, Bone Blades (Green) - BB5.5, 7.5, & 10.0, ""D"" Shape (Black) - D1-4.0, D2-5.5, D3-7.5, & D4-10.0, Round Tapered (White) - RT2.0, 3.0, 4.0, & 5.0 Round Parallel Pointed (Yellow) - RP3.0, 3.5, 4.0, 4.5, & 5.0, Round Parallel Blunt (Red) - RB3.0, 3.5, 4.0, 4.5, & 5.0"
Published
2020-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00083208002229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00083208002229000832080022290832080022290083208002229

GMDN Terms#

Term, Definition table
TermDefinition
Dental osteotome setA 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 or hammer. These are used for ridge expanding, bone condensing and sinus floor elevation procedures. This is a reusable device.

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
Premarket exempt
true
Kit
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00083208102202Tatum Surgical-AnalogAnalog ITI 5.0 DIMAnalog ITI 5.0 DIM2026-02-12
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
00083208130519Scalpel RemoverScalpel Remover T/CScalpel Remover T/C2021-08-06
00083208191121Tatum Sinus Instrument Kit Tatum Sinus KitTatum Sinus Kit2024-09-25
00083208130274RulerRulerRuler2021-02-03
00083208162220Tatum EZ Out Periotome E KitTatum EZ Out Periotome E KitTatum EZ Out Periotome E Kit2024-07-30
00083208130052Tatum Offset Seating toolSeating ToolSeating tool O/S2020-04-20
00083208130403Tatum Straight Seating toolSeating ToolSeating tool Straight2020-04-20
00083208000003Tatum Surgical Bone Fixation Screw KitE-Z bone Fixation Screw KitEZ-Bone Fixation Screw Kit2020-11-13
00083208006135Tatum Surgical Bone Fixation ScrewBone Fix Scw 1.5x3mmBone Fix Scw 1.5x3mm2019-12-24
00083208006142Tatum Surgical Bone Fixation ScrewBone Fix Scw 1.5x4mmBone Fix Scw 1.5x4mm2019-12-24
00083208006173Tatum Surgical Bone Fixation ScrewBone Fix Scw 1.75x8mmBone Fix Scw 1.75x8mm2019-12-24
00083208006180Tatum Surgical Bone Fixation ScrewBone Fix Scw 1.75x10mmBone Fix Scw 1.75x10mm2019-12-24
00083208006197Tatum Surgical Bone Fixation ScrewBone Fix Scw 1.75x12mmBone Fix Scw 1.75x12mm2019-12-24
00083208006203Tatum Surgical Bone Fixation ScrewBone Fix Scw 1.75x14mmBone Fix Scw 1.75x14mm2019-12-24
00083208006210Tatum Surgical Bone Fixation ScrewBone Fix Scw 1.5x15mmBone Fix Scw 1.5x15mm2019-12-24
00083208006227Tatum Surgical Bone Fixation ScrewBone Fix Scw 1.5x18mmBone Fix Scw 1.5x18mm2019-12-24
00083208006234Tatum Surgical Bone Fixation ScrewBone Fix Scw 1.5x21mmBone Fix Scw 1.5x21mm2019-12-24
00083208006241Tatum Surgical Bone Fixation ScrewBone Fix Scw 1.5x24mmBone Fix Scw 1.5x24mm2019-12-24

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