FDA.reportPublic FDA data

TatumSurgical/3.7-4.5x5.0mm Integrity Platform Switch Healing Cuff

Primary DI
00083208345562
Brand
TatumSurgical/3.7-4.5x5.0mm Integrity Platform Switch Healing Cuff
Company
Suncoast Dental, Inc
Model
3.7-4.5x5.0mm Integrity PS-HC
Catalog number
HCS-ITI-PS 3.7-4.5x5.0mm
Device description
3.7-4.5 x 5.0mm Integrity Platform Switch Healing Cuff
Published
2018-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
00083208345562PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00083208345562000832083455620832083455620083208345562

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure kitA collection of prefabricated dental devices and components used to create a suprastructure on a dental implant to mimic preparations of natural teeth. It is used during dental implant restorative and laboratory procedures and will typically consist of a direct dental abutment (the device that is screwed into the surgically implanted fixture that creates the anchorage for the prosthetic tooth in the mandible or maxilla), a carrier, an impression pick-up, a replica, a healing cap and a burnout cylinder. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Height5Millimeter
Outer Diameter3.7Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
078352849
Device count
1
DM exempt
true
Premarket exempt
false
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
false

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
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08800020802828ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802835ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
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