The following data is part of a premarket notification filed by Orthoplus, Inc. with the FDA for Adjustable Bite Corrector.
| Device ID | K942492 |
| 510k Number | K942492 |
| Device Name: | ADJUSTABLE BITE CORRECTOR |
| Classification | Spring, Orthodontic |
| Applicant | ORTHOPLUS, INC. 1275 FOURTH ST., SUITE 381 Santa Rosa, CA 95404 |
| Contact | David Lee |
| Correspondent | David Lee ORTHOPLUS, INC. 1275 FOURTH ST., SUITE 381 Santa Rosa, CA 95404 |
| Product Code | ECO |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-25 |
| Decision Date | 1994-07-13 |