The following data is part of a premarket notification filed by Merz Dental Gmbh with the FDA for M-pm-disc.
| Device ID | K134015 |
| 510k Number | K134015 |
| Device Name: | M-PM-DISC |
| Classification | Mouthguard, Prescription |
| Applicant | MERZ DENTAL GMBH 5616 MARIOLA PL NE Albuquerque, NM 87111 |
| Contact | Richard G Hunter |
| Correspondent | Richard G Hunter MERZ DENTAL GMBH 5616 MARIOLA PL NE Albuquerque, NM 87111 |
| 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 | 2013-12-27 |
| Decision Date | 2014-04-11 |
| Summary: | summary |