FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARIES INDICATOR
K Number: K030807
·
Decision Jun 9, 2003
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
16
Applicant Total
31
Review Days
88
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Basic Information
- Device Name
- CARIES INDICATOR
- K Number
- K030807
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1740
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Confi-Dental Products Co.
- Date Received
- March 13, 2003
- Decision Date
- June 9, 2003
- Product Code
- LFC
- 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 |
|---|---|---|---|
| LFC | Device, Caries Detection | FDA class 2 | Dental |
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|---|---|---|---|
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| K946307 | CYRSTALLINE L3 MULTI-USE HYBRID COMPOSITE | Jan 26, 1995 | Substantially Equivalent |
| K940546 | GRANITEC IONOMER RESIN CEMENT | Apr 29, 1994 | Substantially Equivalent |
| K936070 | TREND SET 2 PLUS | Feb 4, 1994 | Substantially Equivalent |
| K935714 | CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITE | Jan 21, 1994 | Substantially Equivalent |
| K933199 | CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL | Jan 6, 1994 | Substantially Equivalent |