510(k) K222549
K222549 is an FDA 510(k) premarket notification submitted by Purgo Biologics, Inc. for the device "OpenTex". The FDA issued a decision of Substantially Equivalent on May 11, 2023. The device falls under product code NPK (Barrier, Synthetic, Intraoral), a Class II device regulated under 21 CFR 872.3930. Purgo Biologics, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 11, 2023
- Date Received
- August 23, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Barrier, Synthetic, Intraoral
- Device Class
- Class II
- Regulation Number
- 872.3930
- Review Panel
- DE
- Submission Type
A synthetic dental barrier is a synthetic material device, such as ptfe, intended to aid in guided tissue and/or bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials.