Carrigen
510(k) K100883
Carrigen is a Class II device made by Etex Corp., cleared under FDA 510(k) K100883 on 21 Dec 2010, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK100883 | Date21 Dec 2010 | StatusActive |
Official records
- FDA 510(k) database K100883
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LYC
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3930
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code LYC (Bone Grafting Material, Synthetic).
- REPLAM HYDROXYAPATITE by Replam Corp.
- SOCKET GRAFT by Steiner Laboratories
- Cytoplast™ PTFE Suture CS072816SS by OSTEOGENICS BIOMEDICAL, INC.
- InRoad® Dental Synthetic Bone Graft by OSTEOGENE TECH CORP
- UNIGRAFT by UNICARE BIOMEDICAL, INC.
- Cytoplast™ Non-Resorbable PTFE Barrier Membranes, Titanium-Reinforced Ti150ATC-1 by OSTEOGENICS BIOMEDICAL, INC.
- OSSEOGUARD® TR150PR-2 by ZimVie US Corp LLC
- NANOGEN by Orthogen, LLC
- ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE by Atrix Laboratories, Inc.
- BOND APATITE by Augma Biomaterials, Ltd.