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

Deltamed GmbH · Predicate Candidate Screening

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

151 daysmedian FDA review time
205 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K2437203Delta UNlimitedDeltamed GmbH2024-12-18150
K230341ACRIFIXDeltamed GmbH2023-04-06570
K2125413Delta Denture Base - 3Delta Denture Bond - 3Delta Denture FDeltamed GmbH2022-01-101510
K2118043Delta CrownDeltamed GmbH2021-12-061780
K200039P pro Crown & BridgeDeltamed GmbH2020-07-312050
K102776EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SDeltamed GmbH2011-02-181470

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