FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELATION MB METAL REINFORCED PLASTIC BRACKET
K Number: K092030
·
Decision Jul 24, 2009
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
41
Applicant Total
13
Review Days
18
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Basic Information
- Device Name
- ELATION MB METAL REINFORCED PLASTIC BRACKET
- K Number
- K092030
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentsply Interntional
- Date Received
- July 6, 2009
- Decision Date
- July 24, 2009
- 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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