Identity
- Trade Name
- TRI-N FDA UDI
- Generic Name
- Screw endosteal dental implant, one-piece FDA UDI
- Device Name
- DENTAL IMPLANT FDA UDI
- Model / Reference
- TRI-N-13mmSR FDA UDI
- Description
- DENTAL IMPLANT FDA UDI
Identifiers
- Catalog Number
- TRI-N-13SR FDA UDI
- Primary DI / UDI-DI
- 07290110722173 FDA UDI
- 510(k) Number
- K941575 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Screw endosteal dental implant, one-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Screw endosteal dental implant, one-piece
Tri-N by Hi-Tec Implants — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Screw endosteal dental implant, one-piece.
- Infinity External Hex System — ACE SURGICAL SUPPLY CO., INC. · Class II
- KJ Mini Implant System — Kj Meditech · Class II
- VERSALIS S PLUS — S.I.N. - Sistema DE Implante Nacional S.A. · Class II
- Zirlux — HENRY SCHEIN, INC. · Class II
- KLOCKNER — SOADCO, S.L. · Class II
- Tryon — S.I.N. - Sistema DE Implante Nacional S.A. · Class II
- KJ Mini Implant System — Kj Meditech · Class II
- Advanced Intermezzo Fixture — Megagen Implant Co. Ltd · Class II
Cleared under the same submission
K941575 also covers:
- HI-TEC IMPLANTS — Hi-Tec Implants
- HI-TEC IMPLANTS — Hi-Tec Implants
- LOGIC — Hi-Tec Implants
- LOGIC — Hi-Tec Implants
- LOGIC — Hi-Tec Implants
- LOGIC /IMPLEX /EXPERT — Hi-Tec Implants
- LOGIC /IMPLEX /EXPERT — Hi-Tec Implants
- LOGIC /IMPLEX /EXPERT — Hi-Tec Implants
- LOGIC /IMPLEX /EXPERT — Hi-Tec Implants
- LOGIC /IMPLEX /EXPERT — Hi-Tec Implants
- LOGIC /IMPLEX /EXPERT — Hi-Tec Implants
- LOGIC /IMPLEX /EXPERT — Hi-Tec Implants
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
- Hi-Tec Implants
Sources (1)
- FDA UDI f971ce65-5bcb-49c2-b13b-a2f1c6f354ae 35 fields · synced Jun 1, 2026