FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DMRC Light Cure Orthodontic Adhesive System
K Number: K142880
·
Decision Feb 4, 2015
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
192
Applicant Total
1
Review Days
125
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Basic Information
- Device Name
- DMRC Light Cure Orthodontic Adhesive System
- K Number
- K142880
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3750
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Daville Materials, LLC
- Date Received
- October 2, 2014
- Decision Date
- February 4, 2015
- 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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