FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
I-ENDO DUAL
K Number: K111623
·
Decision Jan 10, 2012
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
60
Applicant Total
11
Review Days
214
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Basic Information
- Device Name
- I-ENDO DUAL
- K Number
- K111623
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Satelec - Acteon Group
- Date Received
- June 10, 2011
- Decision Date
- January 10, 2012
- Product Code
- EBW
- 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 |
|---|---|---|---|
| EBW | Controller, Foot, Handpiece And Cord | FDA class 1 | Dental |
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| K Number | Device Name | ||
|---|---|---|---|
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| K172137 | PIEZOTOME CUBE | May 3, 2018 | Substantially Equivalent |
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| K132322 | NEWTRON P5 XS B.LED | Mar 11, 2014 | Substantially Equivalent |
| K132267 | NEWTRON P5, NEWTRON P5 B.LED | Mar 10, 2014 | Substantially Equivalent |
| K131151 | ENDOCENTER | Jan 16, 2014 | Substantially Equivalent |
| K131997 | NEWTRON BOOSTER | Nov 26, 2013 | Substantially Equivalent |
| K113430 | PROULTRA PIEZO ULTRASONIC | Feb 23, 2012 | Substantially Equivalent |
| K072030 | IMPLANT CENTER | Nov 19, 2007 | Substantially Equivalent |
| K071424 | PMAX NEWTRON XS | Aug 24, 2007 | Substantially Equivalent |