FDA.reportPublic FDA data

Tatum Surgical / Healing Cuff for 3.7mm Integrity Implant

Primary DI
00083208370779
Brand
Tatum Surgical / Healing Cuff for 3.7mm Integrity Implant
Company
Suncoast Dental, Inc
Model
Healing Cuff for 3.7mm Integrity Implant
Catalog number
Healing Cuff for 3.7mm Integrity Implant
Device description
Healing Cuff for 3.7mm Integrity Implant - Packaged with Implant
Published
2021-05-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00083208370779PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00083208370779000832083707790832083707790083208370779

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter3.7Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(727)536-4880tatumcompliance@gmail.com

Regulatory Flags#

DUNS number
078352849
Device count
1
DM 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 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815967026143RodinPac-Dent, Inc.NDP2026-07-13
00815967029403RodinPac-Dent, Inc.NDP2026-07-13
06942799000004SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000035SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000042SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000073SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000080SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000110SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
D990EK2A0Essentials Kit, 2 ArchSMART DENTURE CONVERSIONS, LLCNDP2026-07-13
D990EK2A0Essentials Kit, 2 ArchSMART DENTURE CONVERSIONS, LLCNHA2026-07-13
07290109748054Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748061Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748078Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748085Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748092Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748108Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748115Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290114710411Healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
07290114712156Abutments-AnalogCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
07290114712613Titanium-basesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
07290116660882Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-07-12
07290116660899Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-07-12
07290116660981Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-07-12
08800313235715SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235722SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235739SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235746SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235753SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235760SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235777SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09