FDA.reportPublic FDA data

Tatum One Piece Implant Kit

Primary DI
00083208111112
Brand
Tatum One Piece Implant Kit
Company
Suncoast Dental, Inc
Model
Standard One Piece Implant Kit 3.0-3.5
Catalog number
ASY One-Piece Kit Base
Device description
Tatum One Piece Implant kit: A kit designed for simplicity and ease of use in placing Tatum One Piece Implants: Kit Includes:DR1.5 Pilot drill, DR2.0 Pilot drill, DR3.0x14, DR3.5x14. HT.02, 12, 13, 14, 15, 20, 21, 31 & 32. Tatum Ratchet.Autoclaveable Cassette/Container for all pieces.
Published
2020-07-31
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
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00083208111112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00083208111112000832081111120832081111120083208111112

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

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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06942799000080SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000110SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
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07290109748054Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
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07290116660882Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-07-12
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