The following data is part of a premarket notification filed by Blue Sky Bio with the FDA for Blue Sky Bio Computerized Orthodontic Bracket System.
| Device ID | K182338 |
| 510k Number | K182338 |
| Device Name: | Blue Sky Bio Computerized Orthodontic Bracket System |
| Classification | Bracket, Plastic, Orthodontic |
| Applicant | Blue Sky Bio 888 E Belvedere Rd Suite 212 Grayslake, IL 60030 |
| Contact | Albert Zickmann |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | DYW |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-08-28 |
| Decision Date | 2018-11-09 |
| Summary: | summary |