The following data is part of a premarket notification filed by Ortho Caps Gmbh with the FDA for Orthocaps Twinaligner.
| Device ID | K180241 |
| 510k Number | K180241 |
| Device Name: | Orthocaps Twinaligner |
| Classification | Aligner, Sequential |
| Applicant | Ortho Caps GmbH An Der Bewer 8 Hamm 59069, DE |
| Contact | Wajeeh Khan |
| Correspondent | Angelica Ayala RMO, Inc. 650 W. Colfax Ave Denver, CO 80204 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-29 |
| Decision Date | 2018-09-28 |
| Summary: | summary |