The following data is part of a premarket notification filed by Juvora, Ltd. with the FDA for Juvora Oyster White Dental Disc, Ceramill Peek By Juvora, Oyster White.
| Device ID | K181331 |
| 510k Number | K181331 |
| Device Name: | JUVORA Oyster White Dental Disc, CERAMILL PEEK By JUVORA, Oyster White |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | Juvora, Ltd. Technology Centre, Hillhouse International Thornton-clevelys, GB Fy5 4qd |
| Contact | Tim Leyva |
| Correspondent | Tim Leyva Juvora, Ltd. Technology Centre, Hillhouse International Thornton-clevelys, 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 | 2018-05-21 |
| Decision Date | 2018-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055948229681 | K181331 | 000 |
| 05055948229292 | K181331 | 000 |
| 05055948229308 | K181331 | 000 |
| 05055948229315 | K181331 | 000 |
| 05055948229612 | K181331 | 000 |
| 05055948229629 | K181331 | 000 |
| 05055948229636 | K181331 | 000 |
| 05055948229643 | K181331 | 000 |
| 05055948229650 | K181331 | 000 |
| 05055948229667 | K181331 | 000 |
| 05055948229674 | K181331 | 000 |
| 05055948229254 | K181331 | 000 |