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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Schutz Dental GmbH · Predicate Candidate Screening

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

137 daysmedian FDA review time
517 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K151399Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo USchutz Dental GmbH2016-10-245170
K133268TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TSchutz-Dental GmbH2015-02-124760
K071010TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKSSchutz-Dental GmbH2007-08-241370
K052073FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN ASchutz-Dental GmbH2005-10-26860
K052189REVENEER CERAMIC REPAIR SYSTEMSchutz-Dental GmbH2005-10-17670
K051050SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML,Schutz-Dental GmbH2005-06-29650

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