The following data is part of a premarket notification filed by Oracrew with the FDA for Compleclear Plastic Orthodontic Bracket And Wire Appliance.
| Device ID | K150830 |
| 510k Number | K150830 |
| Device Name: | CompleClear Plastic Orthodontic Bracket And Wire Appliance |
| Classification | Bracket, Plastic, Orthodontic |
| Applicant | ORACREW 210 E Flamingo Rd. #217 Las Vegas, NV 89169 |
| Contact | Pawan Gautam |
| Correspondent | Angela Blackwell BLACKWELL DEVICE CONSULTING P.O. BOX 5845 Statesville, NC 28687 |
| Product Code | DYW |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-30 |
| Decision Date | 2016-08-26 |
| Summary: | summary |