510(k) K192612
K192612 is an FDA 510(k) premarket notification submitted by Kerecis Limited for the device "Kerecis Gingiva Graft". The FDA issued a decision of Substantially Equivalent on November 13, 2020. The device falls under product code NPL (Barrier, Animal Source, Intraoral), a Class II device regulated under 21 CFR 872.3930. Kerecis Limited has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 13, 2020
- Date Received
- September 20, 2019
- 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
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.