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 |