The following data is part of a premarket notification filed by Ceramisys Ltd with the FDA for Reprobone Dental Grafting Material.
| Device ID | K103820 |
| 510k Number | K103820 |
| Device Name: | REPROBONE DENTAL GRAFTING MATERIAL |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | CERAMISYS LTD 344 ANNABELLE POINT ROAD Centerville, MA 02632 -2402 |
| Contact | Hillard W Welch |
| Correspondent | Hillard W Welch CERAMISYS LTD 344 ANNABELLE POINT ROAD Centerville, MA 02632 -2402 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-30 |
| Decision Date | 2011-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060171623458 | K103820 | 000 |
| 05060171623298 | K103820 | 000 |
| 05060171623304 | K103820 | 000 |
| 05060171623311 | K103820 | 000 |
| 05060171623328 | K103820 | 000 |
| 05060171623335 | K103820 | 000 |
| 05060171623342 | K103820 | 000 |
| 05060171623359 | K103820 | 000 |
| 05060171623366 | K103820 | 000 |
| 05060171623373 | K103820 | 000 |
| 05060171623380 | K103820 | 000 |
| 05060171623397 | K103820 | 000 |
| 05060171623403 | K103820 | 000 |
| 05060171623410 | K103820 | 000 |
| 05060171623427 | K103820 | 000 |
| 05060171623434 | K103820 | 000 |
| 05060171623441 | K103820 | 000 |
| 05060171623281 | K103820 | 000 |