The following data is part of a premarket notification filed by Blue Sky Bio with the FDA for Blue Sky Bio Dental Implant System.
| Device ID | K010882 |
| 510k Number | K010882 |
| Device Name: | BLUE SKY BIO DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BLUE SKY BIO 5455 N. SHERIDAN RD. #3608 Chicago, IL 60640 |
| Contact | Albert Zickmann |
| Correspondent | Albert Zickmann BLUE SKY BIO 5455 N. SHERIDAN RD. #3608 Chicago, IL 60640 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-23 |
| Decision Date | 2001-09-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815131026405 | K010882 | 000 |
| 00815131024630 | K010882 | 000 |
| 00815131024623 | K010882 | 000 |
| 00815131024616 | K010882 | 000 |
| 00815131024609 | K010882 | 000 |
| 00815131022377 | K010882 | 000 |
| 00815131022360 | K010882 | 000 |
| 00815131022339 | K010882 | 000 |
| 00815131022322 | K010882 | 000 |
| 00815131024647 | K010882 | 000 |
| 00815131026115 | K010882 | 000 |
| 00815131026122 | K010882 | 000 |
| 00815131026399 | K010882 | 000 |
| 00815131026368 | K010882 | 000 |
| 00815131026351 | K010882 | 000 |
| 00815131026344 | K010882 | 000 |
| 00815131026337 | K010882 | 000 |
| 00815131026245 | K010882 | 000 |
| 00815131026153 | K010882 | 000 |
| 00815131026146 | K010882 | 000 |
| 00815131022315 | K010882 | 000 |