Cytoflex Resorb 20x25mm
Cytoflex Resorb 20x25mm (C03-0201) is a Class II device made by Unicare Biomedical, Inc., cleared under FDA 510(k) K090083 on 23 Mar 2009 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI D767C0302010), active as of 23 Oct 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 | NumberD767C0302010 | Date24 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK090083 | Date23 Mar 2009 | StatusActive |
Official records
- FDA 510(k) database K090083
Across registries
- FDA 510(k) K090083 decided 23 Mar 2009 Active
- FDA GUDID UDI-DI D767C0302010 listed 24 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K090083
- Listed FDA GUDID D767C0302010
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cytoflex Resorb
- Generic name
- Pliable-polymer dental regeneration membrane, bioabsorbable, ligated
- Model / Ref / Catalog
- 20x25mm, C03-0201
- Primary DI / UDI-DI
- D767C0302010
- 510(k) Number
- FDA product code
- NPK
- GMDN term
- Pliable-polymer dental regeneration membrane, bioabsorbable, ligated
- Device class
- Class II
- Regulation number
- 872.3930
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code NPK (Barrier, Synthetic, Intraoral).
- GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE by W. L. Gore & Associates, Inc.
- IMTEC/BIOBARRIER MEMBRANE by Imtec Corp.
- GUIDOR(TM) by Procordia Oratech AB
- Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm by SALVIN DENTAL SPECIALTIES, LLC
- InnoGenic Non-resorbable Membrane by Cowellmedi Co., Ltd
- TEFGEN GUIDED TISSUE MEMBRANE by American Custom Medical, Inc.
- INION GTR BIODEGRADABLE MEMBRANE SYSTEM by Inion, Ltd.
- Cytoplast Titanium-Reinforced PTFE Membranes by OSTEOGENICS BIOMEDICAL, INC.
- MEDPOR CONTAIN IMPLANT by Porex Surgical, Inc.
- GORE-TEX REGENERATIVE MATERIAL by W. L. Gore & Associates, Inc.