The following data is part of a premarket notification filed by Novabone Products, Llc with the FDA for Novabone Dental Putty-bioactive Synthetic Bone Graft.
| Device ID | K100671 |
| 510k Number | K100671 |
| Device Name: | NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | NovaBone Products, LLC 13631 PROGRESS BLVD SUITE 600 Alachua, FL 32615 |
| Contact | David M Gaisser |
| Correspondent | David M Gaisser NovaBone Products, LLC 13631 PROGRESS BLVD SUITE 600 Alachua, FL 32615 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-09 |
| Decision Date | 2010-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813909012032 | K100671 | 000 |
| 00813909010632 | K100671 | 000 |
| 00813909010649 | K100671 | 000 |
| 00813909010656 | K100671 | 000 |
| 00813909010663 | K100671 | 000 |
| 00813909010670 | K100671 | 000 |
| 00813909010687 | K100671 | 000 |
| 00813909010694 | K100671 | 000 |
| 00813909010700 | K100671 | 000 |
| 00813909010717 | K100671 | 000 |
| 00813909010724 | K100671 | 000 |
| 00813909010731 | K100671 | 000 |
| 00813909010748 | K100671 | 000 |
| 00813909010755 | K100671 | 000 |
| 00813909010762 | K100671 | 000 |
| 00813909010779 | K100671 | 000 |
| 00813909010557 | K100671 | 000 |