The following data is part of a premarket notification filed by Blue Sky Bio, Llc with the FDA for Blue Sky Bio Dental Taper Hex Implant Systems.
| Device ID | K112875 |
| 510k Number | K112875 |
| Device Name: | BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BLUE SKY BIO, LLC 888 E BELVIDERE RD. SUITE 212 Grayslake, IL 60030 |
| Contact | Michele Vovolka |
| Correspondent | Michele Vovolka BLUE SKY BIO, LLC 888 E BELVIDERE RD. SUITE 212 Grayslake, IL 60030 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-30 |
| Decision Date | 2012-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815131026214 | K112875 | 000 |
| 00815131023497 | K112875 | 000 |
| 00815131023466 | K112875 | 000 |
| 00815131023190 | K112875 | 000 |
| 00815131023169 | K112875 | 000 |
| 00815131020045 | K112875 | 000 |
| 00815131020038 | K112875 | 000 |
| 00815131020021 | K112875 | 000 |
| 00815131020014 | K112875 | 000 |
| 00815131024906 | K112875 | 000 |
| 00815131024913 | K112875 | 000 |
| 00815131024920 | K112875 | 000 |
| 00815131026085 | K112875 | 000 |
| 00815131026078 | K112875 | 000 |
| 00815131026061 | K112875 | 000 |
| 00815131026054 | K112875 | 000 |
| 00815131026047 | K112875 | 000 |
| 00815131025965 | K112875 | 000 |
| 00815131025040 | K112875 | 000 |
| 00815131025033 | K112875 | 000 |
| 00815131020007 | K112875 | 000 |