The following data is part of a premarket notification filed by Euroteknika with the FDA for Universal, Aesthetica, Natea, Natura.
| Device ID | K083670 |
| 510k Number | K083670 |
| Device Name: | UNIVERSAL, AESTHETICA, NATEA, NATURA |
| Classification | Implant, Endosseous, Root-form |
| Applicant | EUROTEKNIKA 1100 RENE-LEVESQUE-BLVD WEST -25TH FLOOR Montreal, Quebec, CA H3b 5c9 |
| Contact | Emmanuel Montini |
| Correspondent | Emmanuel Montini EUROTEKNIKA 1100 RENE-LEVESQUE-BLVD WEST -25TH FLOOR Montreal, Quebec, CA H3b 5c9 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-11 |
| Decision Date | 2009-07-23 |
| Summary: | summary |