Identity
- Trade Name
- Trilor FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Disk ø 98 mm. H. 16 Pink FDA UDI
- Model / Reference
- FDS16PP FDA UDI
- Description
- Disk ø 98 mm. H. 16 Pink FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056099232015 FDA UDI
- 510(k) Number
- K173643 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
Yes
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Height — 16 Millimeter FDA UDI
Category: Dental implant suprastructure, permanent, preformed
Trilor is a prefabricated dental implant support structure designed for permanent intermediate fixation between a dental implant and the final prosthesis/restoration. It features one or more structural components, such as abutments, ball, bar, or coping, made of various materials like titanium (Ti), plastic, or gold alloy. The device is intended to provide a stable and durable platform for implant placement, with some devices including replacement parts during cleaning cycles.
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
- SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
- HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
- DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
- Diamodent — Diamodent · Class II
- Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
Cleared under the same submission
K173643 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Bioloren Srl
Sources (1)
- FDA UDI 4429a110-1e17-4990-8e4b-3d19b7dd2866 35 fields · synced Jul 23, 2026