510(k) K134015
K134015 is an FDA 510(k) premarket notification submitted by Merz Dental GmbH for the device "M-PM-DISC". The FDA issued a decision of Substantially Equivalent on April 11, 2014. The device falls under product code MQC (Mouthguard, Prescription), a Class U device. Merz Dental GmbH has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 11, 2014
- Date Received
- December 27, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mouthguard, Prescription
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type