510(k) K203000
K203000 is an FDA 510(k) premarket notification submitted by Mycone Dental Supply Co. Inc. (Dba Keystone Industries) for the device "KeyPrint KeySplint Hard". The FDA issued a decision of Substantially Equivalent on Apr 9, 2021. The device falls under product code MQC (Mouthguard, Prescription), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 9, 2021
- Date Received
- Oct 1, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mouthguard, Prescription
- Device Class
- Class U
- Review Panel
- DE
- Submission Type
- 510(k)