The following data is part of a premarket notification filed by Blue Sky Bio, Llc with the FDA for Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio Peek Temporary Abutments.
| Device ID | K212785 |
| 510k Number | K212785 |
| Device Name: | Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK Temporary Abutments |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Blue Sky Bio, LLC 800 Liberty Dr. Libertyville, IL 60048 |
| Contact | Albert Zickmann |
| Correspondent | Albert Zickmann Blue Sky Bio, LLC 800 Liberty Dr. Libertyville, IL 60048 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-01 |
| Decision Date | 2022-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810060225462 | K212785 | 000 |
| 00810060225448 | K212785 | 000 |
| 00810060225431 | K212785 | 000 |
| 00810060225424 | K212785 | 000 |
| 00810060225417 | K212785 | 000 |
| 00810060225400 | K212785 | 000 |
| 00810060225394 | K212785 | 000 |
| 00810060225455 | K212785 | 000 |