Identity
- Trade Name
- Tatum Surgical Bone Fixation Screw FDA UDI
- Generic Name
- Craniofacial bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- Bone Fixation Self-Drilling Screw for securing bone blocks FDA UDI
- Model / Reference
- Bone Fix Scw 1.75x12mm FDA UDI
- Description
- Bone Fixation Self-Drilling Screw for securing bone blocks FDA UDI
Identifiers
- Catalog Number
- Bone Fix Scw 1.75x12mm FDA UDI
- Primary DI / UDI-DI
- 00083208006197 FDA UDI
- 510(k) Number
- K141764 FDA UDI
- FDA Product Code
- DZL FDA UDI
- GMDN Term
- Craniofacial bone screw, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4880 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
- Length — 12.0 Millimeter FDA UDIOuter Diameter — 1.75 Millimeter FDA UDI
Category: Craniofacial bone screw, non-bioabsorbable, non-sterile
Tatum Surgical Bone Fixation Screw by Suncoast Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K141764 also covers:
- TriStar Screws - 10mm (Pack of 5) — Impladent
- TriStar Screws - 12mm (Pack of 5) — Impladent
- TriStar Screws - 14mm (Pack of 5) — Impladent
- TriStar Screws - 15mm (Pack of 5) — Impladent
- TriStar Screws - 18mm (Pack of 5) — Impladent
- TriStar Screws - 21mm (Pack of 5) — Impladent
- TriStar Screws - 24mm (Pack of 5) — Impladent
- TriStar Screws - 3mm (Pack of 5) — Impladent
- TriStar Screws - 4mm (Pack of 5) — Impladent
- TriStar Screws - 5mm (Pack of 5) — Impladent
- TriStar Screws - 6mm (Pack of 5) — Impladent
- TriStar Screws - 8mm (Pack of 5) — Impladent
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 ede6789f-e440-420a-be87-b9b85d381602 37 fields · synced May 30, 2026