FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CERAMIC BRACKETS
K Number: K110335
·
Decision May 19, 2011
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
59
Applicant Total
8
Review Days
104
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Basic Information
- Device Name
- CERAMIC BRACKETS
- K Number
- K110335
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho Organizers, Inc.
- Date Received
- February 4, 2011
- Decision Date
- May 19, 2011
- 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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