FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INSIGNIA DIGICAST
K Number: K123118
·
Decision Mar 26, 2013
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
41
Applicant Total
40
Review Days
174
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Basic Information
- Device Name
- INSIGNIA DIGICAST
- K Number
- K123118
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ormco Corp.
- Date Received
- October 3, 2012
- Decision Date
- March 26, 2013
- 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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