FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS
K Number: K112875
·
Decision Jan 27, 2012
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
16
Review Days
119
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS
- K Number
- K112875
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Blue Sky Bio, LLC
- Date Received
- September 30, 2011
- Decision Date
- January 27, 2012
- Product Code
- DZE
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DZE), ordered by most recent decision date.
MegaGen Zygoma Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
INOSS System
FDA 510(k)
FDA Class 2
·Dental
Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant
FDA 510(k)
FDA Class 2
·Dental
Adin Long Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
ZENEX Implant System_Short (R-System)
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Blue Sky Bio, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K232653 | Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX | Apr 3, 2024 | Substantially Equivalent |
| K221845 | Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G | Feb 24, 2023 | Substantially Equivalent |
| K212785 | Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments | Jun 30, 2022 | Substantially Equivalent |
| K202026 | Blue Sky Bio CAD-CAM Abutments | Dec 18, 2020 | Substantially Equivalent |
| K201919 | Blue Sky Bio TAD | Dec 17, 2020 | Substantially Equivalent |
| K190491 | Blue Sky Bio Zygomatic Implant System | Aug 12, 2019 | Substantially Equivalent |
| K180107 | Blue Sky Bio Aligner | Feb 9, 2018 | Substantially Equivalent |
| K153064 | Blue Sky Bio Zygomatic Implant System | Apr 29, 2016 | Substantially Equivalent |
| K110198 | BLUE SKY BIO TCP | Dec 22, 2011 | Substantially Equivalent |
| K102034 | BLUE SKY BIO DENTAL IMPLANT SYSTEM | Apr 19, 2011 | Substantially Equivalent |