The following data is part of a premarket notification filed by Blue Sky Bio, Llc with the FDA for Blue Sky Bio Cad-cam Abutments.
| Device ID | K202026 |
| 510k Number | K202026 |
| Device Name: | Blue Sky Bio CAD-CAM Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Blue Sky Bio, LLC 800 Liberty Drive Libertyville, IL 60048 |
| Contact | Michele Kupcso |
| Correspondent | Kevin A. Thomas PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-22 |
| Decision Date | 2020-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810060221372 | K202026 | 000 |
| 00810060225486 | K202026 | 000 |
| 00810060224991 | K202026 | 000 |
| 00810060224724 | K202026 | 000 |
| 00810060224694 | K202026 | 000 |
| 00810060224700 | K202026 | 000 |
| 00810060222492 | K202026 | 000 |
| 00810060222508 | K202026 | 000 |
| 00810060222515 | K202026 | 000 |
| 00810060221297 | K202026 | 000 |
| 00810060221303 | K202026 | 000 |
| 00810060221310 | K202026 | 000 |
| 00810060221327 | K202026 | 000 |
| 00810060221334 | K202026 | 000 |
| 00810060221341 | K202026 | 000 |
| 00810060221358 | K202026 | 000 |
| 00810060221365 | K202026 | 000 |
| 00810060225479 | K202026 | 000 |