Atlas FDA

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

3Shape A/S — Predicate Candidate Screening

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

265 daysmedian FDA review time
463 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K200100Abutment Design3Shape A/S2020-10-072650
K1919113Shape Splint Design3Shape A/S2019-11-271330
K180941Ortho System3Shape A/S2018-10-172030
K171634Ortho System3Shape A/S2018-01-172290
K163677Ortho System3Shape A/S2017-04-201140
K161884Ortho System3Shape A/S2017-04-192820
K1514553Shape Abutment Designer Software3Shape A/S2016-09-064630
K1520863Shape Ortho System3Shape A/S2016-04-282760

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