FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION
K Number: K081291
·
Decision May 22, 2008
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
192
Applicant Total
13
Review Days
15
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Basic Information
- Device Name
- PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION
- K Number
- K081291
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.3750
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentsply Interntional
- Date Received
- May 7, 2008
- Decision Date
- May 22, 2008
- Product Code
- DYH
- 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 |
|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | FDA class 2 | Dental |
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|---|---|---|---|
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