The following data is part of a premarket notification filed by 3m Deutschland Gmbh with the FDA for Suglue 3.
| Device ID | K192992 |
| 510k Number | K192992 |
| Device Name: | Suglue 3 |
| Classification | Cement, Dental |
| Applicant | 3M Deutschland GMBH ESPE Platz, Seefeld Bavaria, DE 82229 |
| Contact | Desi W. Soegiarto |
| Correspondent | Prithul Bom 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 | 2019-10-25 |
| Decision Date | 2019-11-05 |