The following data is part of a premarket notification filed by Ormco Corp. with the FDA for Bracket, Metal Reinforced Plastic.
| Device ID | K780239 |
| 510k Number | K780239 |
| Device Name: | BRACKET, METAL REINFORCED PLASTIC |
| Classification | Bracket, Plastic, Orthodontic |
| Applicant | ORMCO CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DYW |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-02-13 |
| Decision Date | 1978-03-15 |