FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HYPERELASTIC WIRE
K Number: K112640
·
Decision Nov 16, 2011
Classifications
1
FEI Numbers
181
Registration Numbers
181
Same Product Code
29
Applicant Total
40
Review Days
65
Basic Information
- Device Name
- HYPERELASTIC WIRE
- K Number
- K112640
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.5410
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ORMCO CORP.
- Date Received
- September 12, 2011
- Decision Date
- November 16, 2011
- Product Code
- DZC
- 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 |
|---|---|---|---|
| DZC | Wire, Orthodontic | FDA class 1 | Dental |
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