FDA.report

TatumSurgical/5.0x3.0mm Integrity Platform Switch Healing Cuff

Primary DI
00083208500367
Brand
TatumSurgical/5.0x3.0mm Integrity Platform Switch Healing Cuff
Company
Suncoast Dental, Inc
Model
5.0x3.0mm Integrity PS-HC
Catalog number
HCS-ITI-PS 5.0x3.0mm
Device description
5.0 x 3mm 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

Related Records

Contact Domains

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous
NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00083208500367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00083208500367000832085003670832085003670083208500367

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0
Height3Millimeter
Outer Diameter5Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(727)536-4880tatumimplants@verivon.net
+1(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

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00083208505218Tatum Surgical IP Press Fit AbutmentIP-PN-5.0 x 5 (CB) AbutmentIP-PN-5.0 x 5 (CB)2021-06-04
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00083208131004DDP Extraction Forceps Forceps (1-A)Forceps (1-A)2022-06-30
00083208131509DDP Extraction Forceps Forceps (150-A)Forceps (150-A)2022-06-30

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