FDA 510(k)
FDA class 1
Substantially Equivalent
🇩🇪 Germany
SMARTmatic
K Number: K163239
·
Decision Mar 17, 2017
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
24
Applicant Total
9
Review Days
119
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Basic Information
- Device Name
- SMARTmatic
- K Number
- K163239
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kaltenbach & Voigt GmbH
- Date Received
- November 18, 2016
- Decision Date
- March 17, 2017
- Product Code
- EFA
- 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 |
|---|---|---|---|
| EFA | Handpiece, Belt And/Or Gear Driven, Dental | FDA class 1 | Dental |
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Other Clearances by Kaltenbach & Voigt GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K182712 | DEXIS CariVu 3-in-1 by KaVo | Nov 23, 2019 | Substantially Equivalent |
| K181110 | PROPHYflex 4 | Apr 10, 2019 | Substantially Equivalent |
| K161488 | ESTETICA Dental Treatment Unit and Accessories | Dec 8, 2016 | Substantially Equivalent |
| K143465 | MASTERmatic LUX | Apr 9, 2015 | Substantially Equivalent |
| K140308 | MASTERSURG / EXPERTSURG | Aug 15, 2014 | Substantially Equivalent |
| K130560 | MASTERTORQUE LUX 8900 L | Sep 27, 2013 | Substantially Equivalent |
| K123402 | DIAGNOCAM | Sep 24, 2013 | Substantially Equivalent |
| K103027 | ELECTROTORQUE TLC | Aug 19, 2011 | Substantially Equivalent |