The following data is part of a premarket notification filed by Mycone Dental Supply Co. Inc. (dba Keystone Industries) with the FDA for Keyprint Keysplint Hard.
| Device ID | K203000 |
| 510k Number | K203000 |
| Device Name: | KeyPrint KeySplint Hard |
| Classification | Mouthguard, Prescription |
| Applicant | Mycone Dental Supply Co. Inc. (DBA Keystone Industries) 480 S. Democrat Road Gibbstown, NJ 08027 |
| Contact | Diamond Bynum |
| Correspondent | Diamond Bynum Mycone Dental Supply Co. Inc. (DBA Keystone Industries) 480 S. Democrat Road Gibbstown, NJ 08027 |
| Product Code | MQC |
| Subsequent Product Code | EBI |
| Subsequent Product Code | KMY |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-01 |
| Decision Date | 2021-04-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H66842200042 | K203000 | 000 |
| H66842000042 | K203000 | 000 |
| H66852233012 | K203000 | 000 |
| H66842201142 | K203000 | 000 |
| H66842200112 | K203000 | 000 |
| H66842000112 | K203000 | 000 |