FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
EDS COMBO-RINSE
K Number: K140846
·
Decision Jul 25, 2014
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
40
Applicant Total
17
Review Days
113
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Basic Information
- Device Name
- EDS COMBO-RINSE
- K Number
- K140846
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Essential Dental Systems, Inc.
- Date Received
- April 3, 2014
- Decision Date
- July 25, 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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| K111541 | ENDO-EXPRESS (R) HANDPIECE | Mar 16, 2012 | Substantially Equivalent |
| K101504 | TI-CORE FLOW | Oct 29, 2010 | Substantially Equivalent |
| K072555 | EDTA PLUS | Dec 13, 2007 | Substantially Equivalent |
| K070401 | ENDO-CHX | Jul 11, 2007 | Substantially Equivalent |
| K063856 | EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM | Feb 6, 2007 | Substantially Equivalent |
| K943475 | ULTRA HYDROPHILIC ALGINAE | Aug 12, 1994 | Substantially Equivalent |
| K922250 | FLEXI-FLOW CEMENT WITH TITANIUM | Jan 26, 1994 | Substantially Equivalent |