The following data is part of a premarket notification filed by Blue Sky Bio with the FDA for Modification To Blue Sky Dental Implant System.
| Device ID | K021833 |
| 510k Number | K021833 |
| Device Name: | MODIFICATION TO BLUE SKY 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-04 |
| Decision Date | 2002-06-10 |
| Summary: | summary |