The following data is part of a premarket notification filed by Curasan Ag with the FDA for Osbone Dental.
| Device ID | K102872 |
| 510k Number | K102872 |
| Device Name: | OSBONE DENTAL |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | CURASAN AG 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Cynthia J Nolte |
| Correspondent | Cynthia J Nolte CURASAN AG 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-30 |
| Decision Date | 2011-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 42604764313268 | K102872 | 000 |
| 04260476431203 | K102872 | 000 |
| ECURH20V0250 | K102872 | 000 |
| ECURH20M1000 | K102872 | 000 |
| ECURH10V1000 | K102872 | 000 |
| ECURH10V0250 | K102872 | 000 |
| ECURH10M1000 | K102872 | 000 |
| ECURH10M0250 | K102872 | 000 |
| ECURH05V1000 | K102872 | 000 |
| ECURH05V0250 | K102872 | 000 |
| ECURH05M1000 | K102872 | 000 |
| 04260476431210 | K102872 | 000 |
| 04260476431227 | K102872 | 000 |
| 42604764313190 | K102872 | 000 |
| 42604764313022 | K102872 | 000 |
| 42604764312346 | K102872 | 000 |
| 42604764312278 | K102872 | 000 |
| 42604764312100 | K102872 | 000 |
| 42604764312032 | K102872 | 000 |
| 04260476431326 | K102872 | 000 |
| 04260476431319 | K102872 | 000 |
| 04260476431302 | K102872 | 000 |
| 04260476431234 | K102872 | 000 |
| ECURH05M0250 | K102872 | 000 |