The following data is part of a premarket notification filed by Merz Dental Gmbh with the FDA for Promolux, Promolux Hi, Weropress, Premeco Pcs.
| Device ID | K130076 |
| 510k Number | K130076 |
| Device Name: | PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | 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 | 2013-01-14 |
| Decision Date | 2013-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7091020039 | K130076 | 000 |
| D7091020005 | K130076 | 000 |
| D7091020007 | K130076 | 000 |
| D7091020008 | K130076 | 000 |
| D7091020009 | K130076 | 000 |
| D7091020015 | K130076 | 000 |
| D7091020016 | K130076 | 000 |
| D7091020029 | K130076 | 000 |
| D7091020031 | K130076 | 000 |
| D7091020036 | K130076 | 000 |
| D7091020037 | K130076 | 000 |
| D7091020038 | K130076 | 000 |
| D7091020003 | K130076 | 000 |
| D7091020001 | K130076 | 000 |
| D7091020040 | K130076 | 000 |
| D7091020045 | K130076 | 000 |
| D7091020046 | K130076 | 000 |
| D7091020048 | K130076 | 000 |
| D7091020053 | K130076 | 000 |
| D7091020054 | K130076 | 000 |
| D7091020055 | K130076 | 000 |
| D7091020056 | K130076 | 000 |
| D7091020069 | K130076 | 000 |
| D7091025014 | K130076 | 000 |
| D7091025024 | K130076 | 000 |
| D7091020047 | K130076 | 000 |
| D7091020086 | K130076 | 000 |
| D7091025003 | K130076 | 000 |
| D7091030015 | K130076 | 000 |
| D7091030016 | K130076 | 000 |
| D7091030019 | K130076 | 000 |
| D7091030074 | K130076 | 000 |
| D7091030082 | K130076 | 000 |
| D7091030083 | K130076 | 000 |
| D7091030085 | K130076 | 000 |
| D7091020030 | K130076 | 000 |
| D7091020032 | K130076 | 000 |
| D7091020051 | K130076 | 000 |
| D7091030073 | K130076 | 000 |
| D7091030014 | K130076 | 000 |
| D7091030013 | K130076 | 000 |
| D7091025004 | K130076 | 000 |
| D7091025013 | K130076 | 000 |
| D7091025023 | K130076 | 000 |
| D7091025034 | K130076 | 000 |
| D7091025035 | K130076 | 000 |
| D7091030007 | K130076 | 000 |
| D7091030008 | K130076 | 000 |
| D7091030009 | K130076 | 000 |
| D7091030010 | K130076 | 000 |
| D7091030011 | K130076 | 000 |
| D7091030012 | K130076 | 000 |
| D7091030089 | K130076 | 000 |