FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RADII
K Number: K030568
·
Decision Apr 24, 2003
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
213
Applicant Total
21
Review Days
59
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Basic Information
- Device Name
- RADII
- K Number
- K030568
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Southern Dental Industries, Inc.
- Date Received
- February 24, 2003
- Decision Date
- April 24, 2003
- Product Code
- EBZ
- 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 |
|---|---|---|---|
| EBZ | Activator, Ultraviolet, For Polymerization | FDA class 2 | Dental |
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|---|---|---|---|
| K062065 | RIVA LUTING PLUS | Nov 15, 2006 | Substantially Equivalent |
| K062064 | RIVA BOND LC | Nov 9, 2006 | Substantially Equivalent |
| K050871 | RIVA PROTECT | Jun 10, 2005 | Substantially Equivalent |
| K050870 | RIVA LIGHT CURE | Jun 3, 2005 | Substantially Equivalent |
| K050331 | ADHESIVE 1 | Mar 24, 2005 | Substantially Equivalent |
| K042452 | RIVA SILVER | Dec 7, 2004 | Substantially Equivalent |
| K040393 | RIVA LUTING | Apr 30, 2004 | Substantially Equivalent |
| K032152 | BENCO ADMIX | Aug 6, 2003 | Substantially Equivalent |
| K031658 | BENCO SPHERICAL | Jul 29, 2003 | Substantially Equivalent |
| K030516 | RIVA-SELF CURE | Apr 17, 2003 | Substantially Equivalent |