FDA.reportPublic FDA data

Tatum Surgical-Integrity Platform Switching Abutment 3.7-4.5

Primary DI
00083208134609
Brand
Tatum Surgical-Integrity Platform Switching Abutment 3.7-4.5
Company
Suncoast Dental, Inc
Model
PITI-3.7-4.5 (0°) PS+1.5
Catalog number
PITI-3.7-4.5 (0°) PS+1.5
Device description
Integrity Platform Switching Abutment for 3.7-4.5 implants, 1.5mm larger platform diameter
Published
2021-06-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K811923000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K811923000R & S SERIES IMPLANTSSuncoast Dental Corp.1981-07-24DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00083208134609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00083208134609000832081346090832081346090083208134609

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle0degree
Height7Millimeter

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
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

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