Atlas FDA

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

Elos Medtech Pinol A/S — Predicate Candidate Screening

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

175 daysmedian FDA review time
228 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S2026-05-201750
K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S2025-10-161540
K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S2024-12-101520
K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmElos Medtech Pinol A/S2024-09-13910
K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S2023-12-212300
K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S2023-09-012070
K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S2022-11-301420
K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S2021-02-192280
K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S2020-02-102070
K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S2020-02-062060
K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S2020-01-021150
K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S2019-06-261350
K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S2018-01-152130

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