FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Blue Sky Bio Computerized Orthodontic Bracket System
K Number: K182338
·
Decision Nov 9, 2018
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
41
Applicant Total
5
Review Days
73
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Basic Information
- Device Name
- Blue Sky Bio Computerized Orthodontic Bracket System
- K Number
- K182338
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Blue Sky Bio
- Date Received
- August 28, 2018
- Decision Date
- November 9, 2018
- Product Code
- DYW
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DYW | Bracket, Plastic, Orthodontic | FDA class 2 | Dental |
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CompleClear Plastic Orthodontic Bracket and Wire Appliance
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Other Clearances by Blue Sky Bio
| K Number | Device Name | ||
|---|---|---|---|
| K163251 | Life Essence Universal Porcelain System | Aug 4, 2017 | Substantially Equivalent |
| K021833 | MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM | Jun 10, 2002 | Substantially Equivalent |
| K010882 | BLUE SKY BIO DENTAL IMPLANT SYSTEM | Sep 28, 2001 | Substantially Equivalent |
| K000633 | SYNTHETIC GLASS BONE GRAFT MATERIAL | May 25, 2000 | Substantially Equivalent |