The following data is part of a premarket notification filed by Blue Sky Bio, Llc with the FDA for Drill For Blue Sky Bio Dental Implant System.
| Device ID | K063874 |
| 510k Number | K063874 |
| Device Name: | DRILL FOR BLUE SKY BIO DENTAL IMPLANT SYSTEM |
| 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 | 2006-12-29 |
| Decision Date | 2007-03-29 |
| Summary: | summary |