FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System
K Number: K180404
·
Decision Mar 16, 2018
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
59
Applicant Total
21
Review Days
30
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Basic Information
- Device Name
- 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System
- K Number
- K180404
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3M Healthcare
- Date Received
- February 14, 2018
- Decision Date
- March 16, 2018
- Product Code
- NJM
- 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 |
|---|---|---|---|
| NJM | Bracket, Ceramic, Orthodontic | FDA class 2 | Dental |
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