510(k) K150079
K150079 is an FDA 510(k) premarket notification submitted by Nibec Co., Ltd. for the device "Regenomer® Syringe, Regenomer® Plug, Regenomer® Block". The FDA issued a decision of Substantially Equivalent on Dec 10, 2015. The device falls under product code NPM (Bone Grafting Material, Animal Source), a Class II device regulated under 21 CFR 872.3930. Nibec Co., Ltd. has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 10, 2015
- Date Received
- Jan 15, 2015
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Bone Grafting Material, Animal Source
- Device Class
- Class II
- Regulation Number
- 872.3930
- Review Panel
- DE
- Submission Type
- 510(k)
A animal-source bone grafting material is a naturally-derived device, such as collagen, intended to fill, augment, or reconstruct periodontal defects and or bony defects of the upper or lower jaw.