FDA 510(k)
FDA class 1
Substantially Equivalent
🇩🇪 Germany
MASTERmatic LUX
K Number: K143465
·
Decision Apr 9, 2015
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
24
Applicant Total
9
Review Days
126
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MASTERmatic LUX
- K Number
- K143465
- 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
- December 4, 2014
- Decision Date
- April 9, 2015
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EFA), ordered by most recent decision date.
Dental Handpiece
FDA 510(k)
FDA Class 1
·Dental
SMARTmatic
FDA 510(k)
FDA Class 1
·Dental
RDT3 HANDPIECE HEAD MODEL RDT3
FDA 510(k)
FDA Class 1
·Dental
ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE
FDA 510(k)
FDA Class 1
·Dental
INTRA LUX HEAD 3 LDSY
FDA 510(k)
FDA Class 1
·Dental
LOW & HIGH SPEED KIT
FDA 510(k)
FDA Class 1
·Dental
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 |
| K163239 | SMARTmatic | Mar 17, 2017 | Substantially Equivalent |
| K161488 | ESTETICA Dental Treatment Unit and Accessories | Dec 8, 2016 | 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 |