FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESILIENCE ORTHODONTIC BRACKET ADHES W/BOND RESINS
K Number: K925359
·
Decision Jul 8, 1993
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
191
Applicant Total
31
Review Days
259
Basic Information
- Device Name
- RESILIENCE ORTHODONTIC BRACKET ADHES W/BOND RESINS
- K Number
- K925359
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3750
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- CONFI-DENTAL PRODUCTS CO.
- Date Received
- October 22, 1992
- Decision Date
- July 8, 1993
- 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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