The following data is part of a premarket notification filed by Ormco Corporation with the FDA for Inspire Ice Aka Inspire Ice Clear Brackets.
| Device ID | K171844 |
| 510k Number | K171844 |
| Device Name: | Inspire ICE Aka Inspire ICE Clear Brackets |
| Classification | Bracket, Ceramic, Orthodontic |
| Applicant | Ormco Corporation 1717 W. Collins Avenue Orange, CA 92867 |
| Contact | Tara Bonny |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | NJM |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-06-20 |
| Decision Date | 2017-07-18 |
| Summary: | summary |