The following data is part of a premarket notification filed by Keystone Industries with the FDA for Keyprint Keysplint Soft.
| Device ID | K183598 |
| 510k Number | K183598 |
| Device Name: | KeyPrint KeySplint Soft |
| Classification | Mouthguard, Prescription |
| Applicant | Keystone Industries 480 S. Democrat Rd Gibbstown, NJ 08027 |
| Contact | Negar Movahed |
| Correspondent | Negar Movahed Keystone Industries 480 S. Democrat Rd Gibbstown, NJ 08027 |
| Product Code | MQC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-26 |
| Decision Date | 2019-11-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H66842201551 | K183598 | 000 |
| H66842200051 | K183598 | 000 |
| H66842001551 | K183598 | 000 |
| H66842000051 | K183598 | 000 |
| D040711861 | K183598 | 000 |
| 00810002220173 | K183598 | 000 |