FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802
K Number: K071055
·
Decision May 3, 2007
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
41
Applicant Total
103
Review Days
17
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Basic Information
- Device Name
- OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802
- K Number
- K071055
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ultradent Products, Inc.
- Date Received
- April 16, 2007
- Decision Date
- May 3, 2007
- Product Code
- DYW
- 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 |
|---|---|---|---|
| DYW | Bracket, Plastic, Orthodontic | FDA class 2 | Dental |
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