Identity
- Trade Name
- TatumSurgical/Screw Implant FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- Screw Dental Implant 8.0mm in diameter and 20mm in length FDA UDI
- Model / Reference
- Screw/8.0 x 20 FDA UDI
- Description
- Screw Dental Implant 8.0mm in diameter and 20mm in length FDA UDI
Identifiers
- Catalog Number
- IS8.0x20 FDA UDI
- Primary DI / UDI-DI
- 00083208580208 FDA UDI
- 510(k) Number
- K811923 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 8 Millimeter FDA UDILength — 20 Millimeter FDA UDI
TatumSurgical/Screw Implant 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 d5bf2393-ac70-45d2-8c05-37b44c640ccd 38 fields · synced May 30, 2026