Identity
- Trade Name
- TatumSurgical/D Implant FDA UDI
- Generic Name
- Blade endosteal dental implant, two-piece FDA UDI
- Device Name
- D1S Fin Implant 4.0mm neck diameter, 4.0mm fin width and 16mm in length FDA UDI
- Model / Reference
- D1S - Fin/4.0x4.0x16 FDA UDI
- Description
- D1S Fin Implant 4.0mm neck diameter, 4.0mm fin width and 16mm in length FDA UDI
Identifiers
- Catalog Number
- ID1S 4.0x4.0x16 FDA UDI
- Primary DI / UDI-DI
- 00083208640162 FDA UDI
- 510(k) Number
- K811923 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Blade 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
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Length — 16 Millimeter FDA UDIWidth — 4 Millimeter FDA UDIOuter Diameter — 4 Millimeter FDA UDI
TatumSurgical/D 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 f506c7c5-0d8f-4112-abe9-39b203b0c1ca 38 fields · synced May 29, 2026