Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Kaltenbach & Voigt GmbH · Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

207 daysmedian FDA review time
422 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K182712DEXIS CariVu 3-in-1 by KaVoKaltenbach & Voigt GmbH2019-11-234220
K181110PROPHYflex 4Kaltenbach & Voigt GmbH2019-04-103480
K163239SMARTmaticKaltenbach & Voigt GmbH2017-03-171190
K161488ESTETICA Dental Treatment Unit and AccessoriesKaltenbach & Voigt GmbH2016-12-081900
K143465MASTERmatic LUXKaltenbach & Voigt GmbH2015-04-091260
K140308MASTERSURG / EXPERTSURGKaltenbach & Voigt GmbH2014-08-151890
K130560MASTERTORQUE LUX 8900 LKaltenbach & Voigt GmbH2013-09-272070
K123402DIAGNOCAMKaltenbach & Voigt GmbH2013-09-243230
K103027ELECTROTORQUE TLCKaltenbach & Voigt GmbH2011-08-193100

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda