510(k) K201187
K201187 is an FDA 510(k) premarket notification submitted by Osteogenics Biomedical, Inc. for the device "Cytoplast Titanium-Reinforced PTFE Membranes". The FDA issued a decision of Substantially Equivalent on January 23, 2021. The device falls under product code NPK (Barrier, Synthetic, Intraoral), a Class II device regulated under 21 CFR 872.3930. Osteogenics Biomedical, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 2021
- Date Received
- May 1, 2020
- 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.