The following data is part of a premarket notification filed by 3m Deutschland Gmbh with the FDA for Adh19.
| Device ID | K192961 |
| 510k Number | K192961 |
| Device Name: | ADH19 |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | 3M Deutschland GmbH ESPE Platz Seefeld, DE 82229 |
| Contact | Ruediger Franke |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-10-22 |
| Decision Date | 2019-10-31 |
| Summary: | summary |