Identity
- Trade Name
- Tatum Surgical Integrity Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Integrity Implant Abutment 3.7 - 4.5mm x 15° angled -7mm Height. To fit Integrity Implants diameter sizes 3.7 to 4.5 mm. FDA UDI
- Model / Reference
- Abutment 3.7 - 4.5mm x 15° (Straight) Integrity Post FDA UDI
- Description
- Integrity Implant Abutment 3.7 - 4.5mm x 15° angled -7mm Height. To fit Integrity Implants diameter sizes 3.7 to 4.5 mm. FDA UDI
Identifiers
- Catalog Number
- PITI-3.7 - 4.5 (15°) FDA UDI
- Primary DI / UDI-DI
- 00083208915345 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Height — 7 Millimeter FDA UDIOuter Diameter — 3.2 Millimeter FDA UDI
Category: Dental implant suprastructure, permanent, preformed
Tatum Surgical Integrity Abutment by Suncoast Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Suncoast Dental, Inc.
Sources (1)
- FDA UDI 8937bf24-b88a-4f39-b953-4011f1feb20b 36 fields · synced Jun 1, 2026