Identity
- Trade Name
- TSI OFFSET ABUTMENT FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- 3.25mm OFFSET SHIELD ABUTMENT LONG (SPLINE) FDA UDI
- Model / Reference
- 3.25mm OFFSET SHIELD ABUTMENT LONG SPLINE FDA UDI
- Description
- 3.25mm OFFSET SHIELD ABUTMENT LONG (SPLINE) FDA UDI
Identifiers
- Catalog Number
- 3250 TSI L (SPLINE) FDA UDI
- Primary DI / UDI-DI
- D7853250TSILSP0 FDA UDI
- 510(k) Number
- K090174 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed 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
No
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
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
No
Manufacturing Date
Yes
Category: Dental implant suprastructure, permanent, preformed
For dentists and healthcare professionals, the TSI OFFSET ABUTMENT is a prefabricated device designed to provide a permanent intermediate fixture level between a dental implant and the final prosthesis or restoration. It includes one or more structural components such as abutments, ball, bars, copings, rings, and screws, made of various materials like titanium, plastic, or gold alloy.
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
K090174 also covers:
- 3.25 Abutment — Oco Biomedical
- 3.25mm O-Ball Abutment — Oco Biomedical
- 3.25mm Offset Shielded 15 Degree Abutment — Oco Biomedical
- 4.0/5.0mm O-Ball Abutment — Oco Biomedical
- 4mm & 5mm Straight Pedestal Abutment — Oco Biomedical
- 5mm Offset Shielded 15 Degree Abutment — Oco Biomedical
- BONE LEVEL TIBASE — Oco Biomedical
- Bone Level Abutment — Oco Biomedical
- Bone Level Abutment — Oco Biomedical
- Bone Level Healing Abutment — Oco Biomedical
- Bone Level Healing Screw — Oco Biomedical
- Bone Level Implant Abutment — Oco Biomedical
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Oco Biomedical
Sources (1)
- FDA UDI e0ada77d-e068-4d09-af21-3e7fb32d0bac 35 fields · synced Jul 24, 2026