510(k) K071555
K071555 is an FDA 510(k) premarket notification submitted by Organogenesis, Inc. for the device "FORTAGEN ORAL MEMBRANE". The FDA issued a decision of Substantially Equivalent on Aug 30, 2007. The device falls under product code NPL (Barrier, Animal Source, Intraoral), a Class II device regulated under 21 CFR 872.3930. Organogenesis, Inc. has 11 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 30, 2007
- Date Received
- Jun 7, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Barrier, Animal Source, Intraoral
- Device Class
- Class II
- Regulation Number
- 872.3930
- Review Panel
- DE
- Submission Type
- 510(k)
An animal source dental barrier is an animal-derived material device, such as collagen, intended to aid in guided tissue/bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials when placed around implants.