The following data is part of a premarket notification filed by 3m Espe Dental Products with the FDA for Relyx Luting Plus Automix.
| Device ID | K111185 |
| 510k Number | K111185 |
| Device Name: | RELYX LUTING PLUS AUTOMIX |
| Classification | Cement, Dental |
| Applicant | 3M ESPE DENTAL PRODUCTS 3M CENTER, BUILDING 260-2A-11 St. Paul, MN 55144 -1000 |
| Contact | Bernardo Medellin, J.d. |
| Correspondent | Bernardo Medellin J.d. INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-04-27 |
| Decision Date | 2011-05-05 |
| Summary: | summary |