The following data is part of a premarket notification filed by Merz Dental Gmbh with the FDA for M-pm-disc (pink).
| Device ID | K140758 |
| 510k Number | K140758 |
| Device Name: | M-PM-DISC (PINK) |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| 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 | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-26 |
| Decision Date | 2014-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7091019851 | K140758 | 000 |
| D7091019850 | K140758 | 000 |
| D7091019209 | K140758 | 000 |
| D7091019246 | K140758 | 000 |
| D7091019208 | K140758 | 000 |
| D7091019207 | K140758 | 000 |
| D7091019279 | K140758 | 000 |
| D7091019278 | K140758 | 000 |
| D7091019277 | K140758 | 000 |