The following data is part of a premarket notification filed by Juvora with the FDA for Juvora Dentqal Disc.
| Device ID | K132725 |
| 510k Number | K132725 |
| Device Name: | JUVORA DENTQAL DISC |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | JUVORA TECHNOLOGY CENTRE HILLHOUSE INTERNATIONAL Thornton-cleveleys, Lancashire, GB Fy5 4qd |
| Contact | Selina Shaw |
| Correspondent | Selina Shaw JUVORA TECHNOLOGY CENTRE HILLHOUSE INTERNATIONAL Thornton-cleveleys, Lancashire, GB Fy5 4qd |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-30 |
| Decision Date | 2014-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055948229766 | K132725 | 000 |
| 05055948225393 | K132725 | 000 |
| 05055948225386 | K132725 | 000 |
| 05055948200444 | K132725 | 000 |
| 05055948200437 | K132725 | 000 |
| 05055948200420 | K132725 | 000 |
| 05055948200413 | K132725 | 000 |
| 05055948200406 | K132725 | 000 |
| 05055948200390 | K132725 | 000 |
| 05055948200383 | K132725 | 000 |
| 05055948200376 | K132725 | 000 |
| 05055948200369 | K132725 | 000 |
| 05055948200352 | K132725 | 000 |
| 05055948200345 | K132725 | 000 |
| 05055948228622 | K132725 | 000 |
| 05055948228639 | K132725 | 000 |
| 05055948229759 | K132725 | 000 |
| 05055948229742 | K132725 | 000 |
| 05055948229735 | K132725 | 000 |
| 05055948229728 | K132725 | 000 |
| 05055948229711 | K132725 | 000 |
| 05055948229704 | K132725 | 000 |
| 05055948229698 | K132725 | 000 |
| 05055948229605 | K132725 | 000 |
| 05055948229599 | K132725 | 000 |
| 05055948229582 | K132725 | 000 |
| 05055948229575 | K132725 | 000 |
| 05055948229568 | K132725 | 000 |
| 05055948229551 | K132725 | 000 |
| 05055948200338 | K132725 | 000 |