The following data is part of a premarket notification filed by Great Lakes Orthodontics, Ltd. with the FDA for Exceed Tx.
| Device ID | K150702 |
| 510k Number | K150702 |
| Device Name: | Exceed Tx |
| Classification | Bracket, Plastic, Orthodontic |
| Applicant | GREAT LAKES ORTHODONTICS, LTD. 200 COOPER AVE Tonawanda, NY 14150 |
| Contact | Dave Graver |
| Correspondent | Dave Graver GREAT LAKES ORTHODONTICS, LTD. 200 COOPER AVE Tonawanda, NY 14150 |
| 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 | 2015-03-18 |
| Decision Date | 2016-03-24 |
| Summary: | summary |