The following data is part of a premarket notification filed by Rhondium, Ltd. with the FDA for Rhondium One-visit-crown(ovc).
| Device ID | K143694 |
| 510k Number | K143694 |
| Device Name: | Rhondium One-Visit-Crown(OVC) |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Rhondium, Ltd. 4 Sheffield Street Katikati, NZ 3129 |
| Contact | Greer Fricker |
| Correspondent | Kevin A Thomas PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-24 |
| Decision Date | 2015-05-15 |
| Summary: | summary |