FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT
K Number: K093059
·
Decision Feb 4, 2010
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
130
Applicant Total
3
Review Days
127
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Basic Information
- Device Name
- SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT
- K Number
- K093059
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3765
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Classone Orthodontics, Inc.
- Date Received
- September 30, 2009
- Decision Date
- February 4, 2010
- Product Code
- EBC
- 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 |
|---|---|---|---|
| EBC | Sealant, Pit And Fissure, And Conditioner | FDA class 2 | Dental |
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