The following data is part of a premarket notification filed by Juvora with the FDA for Juvora Dental Disc, Ceramill Peek By Juvora.
| Device ID | K160918 |
| 510k Number | K160918 |
| Device Name: | JUVORA Dental Disc, Ceramill PEEK By JUVORA |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | JUVORA TECHNOLOGY CENTRE, HILLHOUSE INTERNATIONAL Thornton-cleveleys, GB Fy5 4qd |
| Contact | Selina Salthouse |
| Correspondent | Tim Leyva JUVORA TECHNOLOGY CENTRE, HILLHOUSE INTERNATIONAL Thornton-cleveleys, GB Fy5 4qd |
| Product Code | EBI |
| Subsequent Product Code | EBF |
| Subsequent Product Code | EBG |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-04 |
| Decision Date | 2017-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031739582 | K160918 | 000 |
| 07630031739605 | K160918 | 000 |
| 07630031739612 | K160918 | 000 |
| 07630031739629 | K160918 | 000 |
| 07630031739636 | K160918 | 000 |
| 07630031739643 | K160918 | 000 |
| 07630031739650 | K160918 | 000 |
| 07630031739667 | K160918 | 000 |
| 07630031739674 | K160918 | 000 |
| 07630031739681 | K160918 | 000 |
| 07630031739698 | K160918 | 000 |
| 07630031739704 | K160918 | 000 |
| 07630031739711 | K160918 | 000 |
| 07630031739728 | K160918 | 000 |
| 07630031739735 | K160918 | 000 |
| 07630031739599 | K160918 | 000 |