FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLUE SKY BIO DENTAL IMPLANT SYSTEM
K Number: K010882
·
Decision Sep 28, 2001
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
5
Review Days
189
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Basic Information
- Device Name
- BLUE SKY BIO DENTAL IMPLANT SYSTEM
- K Number
- K010882
- 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
- Date Received
- March 23, 2001
- Decision Date
- September 28, 2001
- 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 |
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Other Clearances by Blue Sky Bio
| K Number | Device Name | ||
|---|---|---|---|
| K182338 | Blue Sky Bio Computerized Orthodontic Bracket System | Nov 9, 2018 | Substantially Equivalent |
| K163251 | Life Essence Universal Porcelain System | Aug 4, 2017 | Substantially Equivalent |
| K021833 | MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM | Jun 10, 2002 | Substantially Equivalent |
| K000633 | SYNTHETIC GLASS BONE GRAFT MATERIAL | May 25, 2000 | Substantially Equivalent |