The following data is part of a premarket notification filed by Mycone Dental Supply Co., T/a Keystone Industries with the FDA for Clearmet.
| Device ID | K152051 |
| 510k Number | K152051 |
| Device Name: | ClearMet |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | Mycone Dental Supply Co., T/a Keystone Industries t/a Keystone Industries, Mizzy & Deepak Products 52 West King Street Myerstown, PA 17067 |
| Contact | Tracey Schwear |
| Correspondent | Tracey Schwear Mycone Dental Supply Co., T/a Keystone Industries t/a Keystone Industries, Mizzy & Deepak Products 52 West King Street Myerstown, PA 17067 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-23 |
| Decision Date | 2016-03-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H66810092291 | K152051 | 000 |
| H6681009227 | K152051 | 000 |
| H6681009225 | K152051 | 000 |