FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SMEARCLEAR
K Number: K024198
·
Decision Mar 5, 2003
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
40
Applicant Total
106
Review Days
75
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Basic Information
- Device Name
- SMEARCLEAR
- K Number
- K024198
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sybron Dental Specialties, Inc.
- Date Received
- December 20, 2002
- Decision Date
- March 5, 2003
- Product Code
- KJJ
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| KJJ | Cleanser, Root Canal | FDA unclassified | Unknown |
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| K060469 | OPTIBOND ALL-IN-ONE | Mar 28, 2006 | Substantially Equivalent |
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