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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D709760533 | K134015 | 000 |
| D7091019080 | K134015 | 000 |
| D7091019081 | K134015 | 000 |
| D7091019082 | K134015 | 000 |
| D7091019083 | K134015 | 000 |
| D7091019184 | K134015 | 000 |
| D7091019205 | K134015 | 000 |
| D7091019206 | K134015 | 000 |
| D7091019276 | K134015 | 000 |
| D70952500598220 | K134015 | 000 |
| D709760312 | K134015 | 000 |
| D709760319 | K134015 | 000 |
| D709760532 | K134015 | 000 |
| D7091017910 | K134015 | 000 |