510(k) K200125
K200125 is an FDA 510(k) premarket notification submitted by Erkodent Erich Kopp GmbH for the device "Thermoforming Sheet Materials". The FDA issued a decision of Substantially Equivalent on Oct 28, 2020. The device falls under product code MQC (Mouthguard, Prescription), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 28, 2020
- Date Received
- Jan 21, 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)