Identity
- Trade Name
- TriStar Screws - 8mm (Pack of 5) FDA UDI
- Generic Name
- Craniofacial bone screw, non-bioabsorbable FDA UDI
- Device Name
- Pack of 5 Ti-Alloy Screws, Length: 8mm total, 5mm threaded, 3mm unthreaded FDA UDI
- Model / Reference
- TRI-08 FDA UDI
- Description
- Pack of 5 Ti-Alloy Screws, Length: 8mm total, 5mm threaded, 3mm unthreaded FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855286006174 FDA UDI
- 510(k) Number
- K141764 FDA UDI
- FDA Product Code
- DZL FDA UDI
- GMDN Term
- Craniofacial bone screw, non-bioabsorbable 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
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Category: Craniofacial bone screw, non-bioabsorbable
TriStar Screws - 8mm (Pack of 5) by Impladent — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Craniofacial bone screw, non-bioabsorbable.
- LEVEL ONE CMF — KLS-Martin L.P. · Class II
- OsteoMed — Osteomed Corp. · Class II
- MCI - Medical Concept Innovation, Inc. — MCI MEDICAL CONCEPT INNOVATION INC. · Class II
- LEVEL ONE CMF — KLS-Martin L.P. · Class II
- MatrixMANDIBLE — Synthes · Class II
- OsteoMed — Osteomed Corp. · Class II
- LEVEL ONE NEURO, STERILE — KLS-Martin L.P. · Class II
- Leforte System Bone Screw / GBR System Bone Screw — Jeil Medical Corporation · Class II
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
- Bone Expander Screw Kit — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Impladent
Sources (1)
- FDA UDI 839a9929-6dbe-4f39-ac2e-44fadf7150e5 34 fields · synced Jun 8, 2026