The following data is part of a premarket notification filed by Emergo Global Consulting, Llc with the FDA for Sureclear Aligners.
| Device ID | K171860 |
| 510k Number | K171860 |
| Device Name: | Sureclear Aligners |
| Classification | Aligner, Sequential |
| Applicant | Emergo Global Consulting, LLC 2500 Bee Cave Road, Bldg. 1, Suite 300 Austin, TX 78746 |
| Contact | Stuart R. Goldman |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-06-22 |
| Decision Date | 2018-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856379007030 | K171860 | 000 |
| 00856379007023 | K171860 | 000 |
| 00856379007016 | K171860 | 000 |
| 00856379007009 | K171860 | 000 |
| 00856379007047 | K171860 | 000 |