The following data is part of a premarket notification filed by Ormco Corp. with the FDA for Insignia With Itero.
| Device ID | K123416 |
| 510k Number | K123416 |
| Device Name: | INSIGNIA WITH ITERO |
| Classification | Bracket, Plastic, Orthodontic |
| Applicant | ORMCO CORP. 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Contact | Wendy Garman |
| Correspondent | Wendy Garman ORMCO CORP. 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Product Code | DYW |
| Subsequent Product Code | EJF |
| Subsequent Product Code | NJM |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-06 |
| Decision Date | 2013-03-13 |
| Summary: | summary |