FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
ENDOCYN ROOT CANAL IRRIGATION SOLUTION
K Number: K141352
·
Decision Aug 18, 2014
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
40
Applicant Total
9
Review Days
87
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Basic Information
- Device Name
- ENDOCYN ROOT CANAL IRRIGATION SOLUTION
- K Number
- K141352
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oculus Innovative Sciences
- Date Received
- May 23, 2014
- Decision Date
- August 18, 2014
- 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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|---|---|---|---|
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| K152945 | Alevicyn SG Antipruritic Gel | Dec 15, 2015 | Substantially Equivalent |
| K152055 | Ceramax Skin Barrier Cream | Nov 23, 2015 | Substantially Equivalent |
| K143590 | Alevicyn SG Antipruritic Gel | Jun 4, 2015 | Substantially Equivalent |
| K141012 | HYDROCLEANSE WOUND CARE SOLUTION | Aug 8, 2014 | Substantially Equivalent |
| K131672 | MICROCYN SCAR MANAGEMENT HYDROGEL | Nov 15, 2013 | Substantially Equivalent |