The following data is part of a premarket notification filed by 3m Espe Dental Products with the FDA for 3m Relyx Pediatric Resin Modified Glass Ionomer Cement.
| Device ID | K191122 |
| 510k Number | K191122 |
| Device Name: | 3M RelyX Pediatric Resin Modified Glass Ionomer Cement |
| Classification | Cement, Dental |
| Applicant | 3M ESPE Dental Products 2510 Conway Ave. St. Paul, MN 55144 |
| Contact | Lin Ma |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-04-29 |
| Decision Date | 2019-05-29 |