The following data is part of a premarket notification filed by Ormco Corp. with the FDA for Ormco Transmandibular Implant.
| Device ID | K852894 |
| 510k Number | K852894 |
| Device Name: | ORMCO TRANSMANDIBULAR IMPLANT |
| Classification | Implant, Transmandibular |
| Applicant | ORMCO CORP. 1332 SOUTH LONE HILL AVE. Glendora, CA 91740 |
| Contact | Wendell Lee |
| Correspondent | Wendell Lee ORMCO CORP. 1332 SOUTH LONE HILL AVE. Glendora, CA 91740 |
| Product Code | MDL |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Se - Postmarket Surveillance Required (SESP) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-09 |
| Decision Date | 1985-08-29 |