The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Eactech Optecure Dental And Optecure Dental + Ccc.
| Device ID | K103699 |
| 510k Number | K103699 |
| Device Name: | EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC |
| Classification | Bone Grafting Material, Human Source |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Shing Jen Tai, Phd |
| Correspondent | Shing Jen Tai, Phd EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | NUN |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-20 |
| Decision Date | 2011-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841336100275 | K103699 | 000 |
| 00841336100268 | K103699 | 000 |
| 00841336100251 | K103699 | 000 |
| 00841336100244 | K103699 | 000 |
| 00841336100237 | K103699 | 000 |
| 00841336100220 | K103699 | 000 |