BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS— 510(k) K112875
Substantially EquivalentBlue Sky Bio, LLC
FDA 510(k) clearance K112875 for BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS, Substantially Equivalent on 2012-01-27. Applicant: Blue Sky Bio, LLC. Device class: 2.
Clearance details
- Applicant
- Blue Sky Bio, LLC
- Product code
- Code DZE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Grayslake, IL, US
Recent devices under product code DZE
view allMore clearances from Blue Sky Bio, LLC
view all- K232653 — Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX
- K221845 — Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G
- K212785 — Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments
- K202026 — Blue Sky Bio CAD-CAM Abutments
- K201919 — Blue Sky Bio TAD
Adverse events under product code DZE
product code DZE- Death
- 28
- Injury
- 3,367,041
- Malfunction
- 19,958
- Other
- 13
- Total
- 3,387,040
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.