Impression Coping
Impression Coping (4035 IC/TA) is a Class II device made by Oco Biomedical, cleared under FDA 510(k) K090174 on 14 Sep 2009 and listed in FDA GUDID since 14 Feb 2024 (UDI-DI D7854035ICTA0), active as of 31 May 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberD7854035ICTA0 | Date14 Feb 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK090174 | Date14 Sep 2009 | StatusActive |
Official records
- FDA 510(k) database K090174
Across registries
- FDA 510(k) K090174 decided 14 Sep 2009 Active
- FDA GUDID UDI-DI D7854035ICTA0 listed 14 Feb 2024 Listed
Timeline
- Cleared FDA 510(k) K090174
- Listed FDA GUDID D7854035ICTA0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Dental implant suprastructure, temporary, preformed, single-use
- Model / Ref / Catalog
- IMPRESSION COPING/TEMPORARY ABUTMENT- CLOSED/OPEN TRAY 3.5MM3.5MM, 4035 IC/TA
- Primary DI / UDI-DI
- D7854035ICTA0
- 510(k) Number
- FDA product code
- NHA
- GMDN term
- Dental implant suprastructure, temporary, preformed, single-use
- Device class
- Class II
- Regulation number
- 872.3630
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Dental implant suprastructure, temporary, preformed, single-use.
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