The following data is part of a premarket notification filed by 3m Health Care with the FDA for 3m Clarity Ultra Self-ligating Brackets And Adhesive Coated Appliance System.
| Device ID | K180404 |
| 510k Number | K180404 |
| Device Name: | 3M Clarity Ultra Self-Ligating Brackets And Adhesive Coated Appliance System |
| Classification | Bracket, Ceramic, Orthodontic |
| Applicant | 3M Health Care 2510 Conway Avenue St. Paul, MN 55144 -1000 |
| Contact | Lam Duong |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | NJM |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-02-14 |
| Decision Date | 2018-03-16 |
| Summary: | summary |