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Tatum Surgical-Integrity Platform Switching Abutment 6.0-8.0, 15°
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Tatum Surgical-Integrity Platform Switching Abutment 6.0-8.0, 15° FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- Integrity Platform Switching Abutment for 6.0-8.0 implants, 15°, 1.5mm larger platform diameter FDA UDI
- Model / Reference
- PITI-6.0-8.0 (15°) PS+1.5 FDA UDI
- Description
- Integrity Platform Switching Abutment for 6.0-8.0 implants, 15°, 1.5mm larger platform diameter FDA UDI
Identifiers
- Catalog Number
- PITI-6.0-8.0 (15°) PS+1.5 FDA UDI
- Primary DI / UDI-DI
- 00083208678615 FDA UDI
- 510(k) Number
- K811923 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- Not 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
- Angle — 15 degree FDA UDIHeight — 7.0 Millimeter FDA UDI
Tatum Surgical-Integrity Platform Switching Abutment 6.0-8.0, 15° by Suncoast Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID
Cleared under the same submission
K811923 also covers:
- O-Ring small Black — SUNCOAST DENTAL, INC.
- Tatum Surgical Integrity — SUNCOAST DENTAL, INC.
- Tatum Surgical Integrity — SUNCOAST DENTAL, INC.
- Tatum Surgical-Analog — SUNCOAST DENTAL, INC.
- Tatum Surgical-Analog — SUNCOAST DENTAL, INC.
- Tatum Surgical-Analog — SUNCOAST DENTAL, INC.
- Tatum Surgical-Analog — SUNCOAST DENTAL, INC.
- Tatum Surgical-Analog — SUNCOAST DENTAL, INC.
- Tatum Surgical-Analog — SUNCOAST DENTAL, INC.
- Tatum Surgical/Abutment (Post) — SUNCOAST DENTAL, INC.
- Tatum Surgical/Abutment (Post) — SUNCOAST DENTAL, INC.
- Tatum Surgical/Abutment (Post) — SUNCOAST DENTAL, INC.
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 c4fd3767-f7fb-44ca-91a6-5f6d11666599 38 fields · synced May 30, 2026