The following data is part of a premarket notification filed by Teknimed Sa with the FDA for Odoncer.
| Device ID | K062102 |
| 510k Number | K062102 |
| Device Name: | ODONCER |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | TEKNIMED SA 1001 OAKWOOD BLVD Roundrock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb TEKNIMED SA 1001 OAKWOOD BLVD Roundrock, TX 78681 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-24 |
| Decision Date | 2007-04-16 |
| Summary: | summary |