FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇹 Austria
Composite Orthodontic Brackets and Buttons
K Number: K251196
·
Decision Apr 21, 2025
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
41
Applicant Total
1
Review Days
4
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Basic Information
- Device Name
- Composite Orthodontic Brackets and Buttons
- K Number
- K251196
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ec Certification Service GmbH
- Date Received
- April 17, 2025
- Decision Date
- April 21, 2025
- 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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