The following data is part of a premarket notification filed by Ormco Corp. with the FDA for Spirit Mb.
| Device ID | K955333 |
| 510k Number | K955333 |
| Device Name: | SPIRIT MB |
| Classification | Bracket, Plastic, Orthodontic |
| Applicant | ORMCO CORP. 1332 SOUTH LONE HILL AVE. Glendora, CA 91740 |
| Contact | Larry Wills |
| Correspondent | Larry Wills ORMCO CORP. 1332 SOUTH LONE HILL AVE. Glendora, CA 91740 |
| Product Code | DYW |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-21 |
| Decision Date | 1996-01-04 |