The following data is part of a premarket notification filed by Blue Sky Bio, Llc. with the FDA for Blue Sky Bio Zygomatic Implant System.
| Device ID | K190491 |
| 510k Number | K190491 |
| Device Name: | Blue Sky Bio Zygomatic Implant System |
| 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 | 2019-02-28 |
| Decision Date | 2019-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810060220702 | K190491 | 000 |