Atlas FDA

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

Instrumentarium Dental, Palodex Group OY · Predicate Candidate Screening

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

150 daysmedian FDA review time
310 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K133231DIGORA OPTIMEInstrumentarium Dental, Palodex Group OY2014-03-201500
K093683ORTHOPANTOMOGRAPH OP300Instrumentarium Dental, Palodex Group OY2010-10-063100
K092591ORTHOPANTOMOGRAPH OP30Instrumentarium Dental, Palodex Group OY2009-11-20880
K081925SNAPSHOTInstrumentarium Dental, Palodex Group OY2008-09-02570
K063837SIGMA MInstrumentarium Dental, Palodex Group OY2007-07-021880

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