The following data is part of a premarket notification filed by Signature Orthodontics with the FDA for Signature Orthodontic System.
| Device ID | K181271 |
| 510k Number | K181271 |
| Device Name: | Signature Orthodontic System |
| Classification | Bracket, Ceramic, Orthodontic |
| Applicant | Signature Orthodontics 16 Miner Street Suite 406 Boston, MA 02215 |
| Contact | Alfred Charles Griffin |
| 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 | 2018-05-14 |
| Decision Date | 2018-06-13 |
| Summary: | summary |