The following data is part of a premarket notification filed by Ormco Corp. with the FDA for Band Seater.
| Device ID | K951776 |
| 510k Number | K951776 |
| Device Name: | BAND SEATER |
| Classification | Setter, Band, Orthodontic |
| Applicant | ORMCO CORP. 1332 SOUTH LONE HILL AVE. Glendora, CA 91740 |
| Contact | Jeffrey A Anderson |
| Correspondent | Jeffrey A Anderson ORMCO CORP. 1332 SOUTH LONE HILL AVE. Glendora, CA 91740 |
| Product Code | ECR |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-13 |
| Decision Date | 1995-05-23 |