FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RADIANCE
K Number: K080749
·
Decision Aug 4, 2008
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
59
Applicant Total
45
Review Days
140
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Basic Information
- Device Name
- RADIANCE
- K Number
- K080749
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- American Orthodontics
- Date Received
- March 17, 2008
- Decision Date
- August 4, 2008
- Product Code
- NJM
- 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 |
|---|---|---|---|
| NJM | Bracket, Ceramic, Orthodontic | FDA class 2 | Dental |
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