Identity
- Trade Name
- Bone Level Implant Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- 3.25mm Crown & Bridge Abutment 3.25mm Diameter 1mm Collar For multiple unit restorations only (not for single tooth restoration) FDA UDI
- Model / Reference
- 3.25mm Crown & Bridge Abutment FDA UDI
- Description
- 3.25mm Crown & Bridge Abutment 3.25mm Diameter 1mm Collar For multiple unit restorations only (not for single tooth restoration) FDA UDI
Identifiers
- Catalog Number
- 32530-1CB FDA UDI
- Primary DI / UDI-DI
- D785325301CB0 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
- Not 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
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
Bone Level Implant Abutment by Oco Biomedical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
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
- Oco Biomedical
Sources (1)
- FDA UDI b1d172b4-9357-456c-b32f-2faa51028268 36 fields · synced Jun 6, 2026