The following data is part of a premarket notification filed by Straight T, Inc. with the FDA for Straight T Clear Dental Aligner.
| Device ID | K201450 |
| 510k Number | K201450 |
| Device Name: | Straight T Clear Dental Aligner |
| Classification | Aligner, Sequential |
| Applicant | Straight T, Inc. 16952 W. Bell Rd #301 Surprise, AZ 85374 |
| Contact | Minh Trinh |
| Correspondent | Robert O. Dean Compliance Systems International, LLC. 1083 Delaware Ave. Buffalo, NY 14209 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-01 |
| Decision Date | 2020-09-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860005619016 | K201450 | 000 |