MASTERmatic LUX
FDA 510(k) K143465 · Kaltenbach & Voigt GmbH
510(k) numberK143465
Submission
- Device name
- MASTERmatic LUX
- Applicant
- Kaltenbach & Voigt GmbH
Biberach, DE - Received
- December 4, 2014
- Decision date
- April 9, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K192809 | Dental HandpieceEFA · Traditional | Micro-Nx Co., Ltd. | 08/25/2020SE |
| K163239 | SMARTmaticEFA · Traditional | Kaltenbach & Voigt GmbH | 03/17/2017SE |
| K101172 | RDT3 Handpiece Head Model RDT3EFA · Traditional | Redent Nova, Ltd. | 07/27/2010SE |
| K093894 | Anthogyr Impulsion Implantology Contra-AngleEFA · Special | Anthogyr | 03/03/2010SE |
| K092446 | Intra Lux Head 3 LdsyEFA · Traditional | Kaltenbach & Voigt GmbH & Co. | 11/03/2009SE |
| K090055 | Low & High Speed KitEFA · Traditional | Dpm USA Corp. | 10/27/2009SE |
| K092412 | Strong Implant HandpiecesEFA · Traditional | Saeshin Precision Co., Ltd. | 09/03/2009SE |
| K090676 | Montblanc Implantology and Omnipratique Contra-AnglesEFA · Special | Anthogyr | 05/22/2009SE |
| K070084 | Montblanc Implantology Contra Angle ControlEFA · Special | Est. Anthogyr | 03/08/2007SE |
| K061701 | High Speed Air Turbine Handpieces, PAR-4HEX/4HX Series (Twin Power Turbine 4H)EFA · Traditional | J. Morita USA, Inc. | 08/25/2006SE |
More from J. Morita USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K182712 | DEXIS CariVu 3-in-1 by KaVoNTK · Traditional | 11/23/2019SE |
| K181110 | PROPHYflex 4EFB · Traditional | 04/10/2019SE |
| K163239 | SMARTmaticEFA · Traditional | 03/17/2017SE |
| K161488 | ESTETICA Dental Treatment Unit and AccessoriesEIA · Traditional | 12/08/2016SE |
| K140308 | Mastersurg / ExpertsurgEBW · Traditional | 08/15/2014SE |
| K130560 | Mastertorque Lux 8900 LEFB · Traditional | 09/27/2013SE |
| K123402 | DiagnocamNTK · Traditional | 09/24/2013SE |
| K103027 | Electrotorque TLCEBW · Traditional | 08/19/2011SE |
| K092446 | Intra Lux Head 3 LdsyEFA · Traditional | 11/03/2009SE |
| K080677 | Comfortronic 4894 and Comfortdrive 200XDA HandpieceEIA · Traditional | 06/06/2008SE |
Questions and answers
When was MASTERmatic LUX cleared by the FDA?
MASTERmatic LUX (K143465) received a 510(k) decision of Substantially Equivalent on April 9, 2015, 126 days after the submission was received.
What is the product code of K143465?
The FDA product code is EFA – Handpiece, Belt And/Or Gear Driven, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.