FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KAR-D-TEK
K Number: K913405
·
Decision Oct 28, 1991
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
16
Applicant Total
7
Review Days
90
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Basic Information
- Device Name
- KAR-D-TEK
- K Number
- K913405
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1740
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gresco Products, Inc.
- Date Received
- July 30, 1991
- Decision Date
- October 28, 1991
- 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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SEE-IT CARIES DETECTOR
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CARIES INDICATOR
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Other Clearances by Gresco Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K981524 | PRILANE | Jul 10, 1998 | Substantially Equivalent |
| K910813 | MET-ETCH | May 7, 1991 | Substantially Equivalent |
| K910803 | ENAMEL ETCHING GEL | Mar 15, 1991 | Substantially Equivalent |
| K901973 | CP-3 DENTAL POLISHING MATERIAL | Jun 1, 1990 | Substantially Equivalent |
| K854495 | GRESCO N.P. DENTAL ALLOY | Dec 27, 1985 | Substantially Equivalent |
| K854494 | CERAM-ETCH | Dec 23, 1985 | Substantially Equivalent |