The following data is part of a premarket notification filed by Novabone Products, Llc with the FDA for Novabone Dental Morsels - Bioactive Synthetic Bone Graft.
| Device ID | K112428 |
| 510k Number | K112428 |
| Device Name: | NOVABONE DENTAL MORSELS - 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-23 |
| Decision Date | 2011-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813909012285 | K112428 | 000 |
| 00813909012278 | K112428 | 000 |
| 00813909012261 | K112428 | 000 |
| 00813909012254 | K112428 | 000 |