Identity
- Trade Name
- Tatum Surgical IP Press Fit Angled Abutment FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- 4.5 x 15° (Degree) Non-Shouldered Angled Abutment for 4.5-5.0mm Diameter "P" Implants 6.5mm Height, (3.0mm Well) FDA UDI
- Model / Reference
- IP-PN-4.5 x 15° Abutment FDA UDI
- Description
- 4.5 x 15° (Degree) Non-Shouldered Angled Abutment for 4.5-5.0mm Diameter "P" Implants 6.5mm Height, (3.0mm Well) FDA UDI
Identifiers
- Catalog Number
- IP-PN-4.5 x 15° Abutment FDA UDI
- Primary DI / UDI-DI
- 00083208457210 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
- Outer Diameter — 4.5 Millimeter FDA UDIHeight — 6.5 Millimeter FDA UDIAngle — 15 degree FDA UDI
Tatum Surgical IP Press Fit Angled Abutment by Suncoast Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 53c16d7a-274a-4d41-9cfd-4d1554ec3e57 38 fields · synced May 30, 2026