FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIGHT BOND
K Number: K880793
·
Decision Jun 13, 1988
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
191
Applicant Total
28
Review Days
108
Basic Information
- Device Name
- LIGHT BOND
- K Number
- K880793
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3750
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- RELIANCE ORTHODONTIC PRODUCTS, INC.
- Date Received
- February 26, 1988
- Decision Date
- June 13, 1988
- 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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|---|---|---|---|
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| K071590 | THERMA-CURE | Jul 31, 2007 | Substantially Equivalent |
| K033551 | EVOLVE | Dec 16, 2003 | Substantially Equivalent |
| K001048 | LIGHT BOND (QUICK CURE) | Apr 27, 2000 | Substantially Equivalent |