The following data is part of a premarket notification filed by Blue Sky Bio, Llc. with the FDA for Blue Sky Bio Tad.
| Device ID | K201919 |
| 510k Number | K201919 |
| Device Name: | Blue Sky Bio TAD |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | Blue Sky Bio, LLC. 800 Liberty Drive Libertyville, IL 60048 |
| Contact | Sharon Nichols |
| Correspondent | Juan Tezak Compliance 4 Devices 118 W Prive Cr. Delray Beach, FL 33445 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-10 |
| Decision Date | 2020-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810060224977 | K201919 | 000 |
| 00810060224960 | K201919 | 000 |
| 00810060224953 | K201919 | 000 |
| 00810060224946 | K201919 | 000 |