The following data is part of a premarket notification filed by Perfect Fit Crowns, Llc with the FDA for C-30 Crown Kit.
| Device ID | K211345 |
| 510k Number | K211345 |
| Device Name: | C-30 Crown Kit |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Perfect Fit Crowns, LLC 1128 Royal Palm Beach Blvd, #166 Royal Palm Beach, FL 33411 |
| Contact | Steve Ziskind |
| Correspondent | Tim Torbenson evo820, LLC 1 Baya Street Rancho Mission Viejo, CA 92694 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-03 |
| Decision Date | 2021-11-24 |