The following data is part of a premarket notification filed by Qserve America, Inc. with the FDA for Clearpath Aligner.
| Device ID | K123514 |
| 510k Number | K123514 |
| Device Name: | CLEARPATH ALIGNER |
| Classification | Aligner, Sequential |
| Applicant | QSERVE AMERICA, INC. 154 MAIN STREET, STE 2 Charlestown, NH 03603 |
| Contact | Patsy Trisler |
| Correspondent | Patsy Trisler QSERVE AMERICA, INC. 154 MAIN STREET, STE 2 Charlestown, NH 03603 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-14 |
| Decision Date | 2013-11-01 |
| Summary: | summary |