Atlas FDA

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

Truabutment, Inc. — Predicate Candidate Screening

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

297 daysmedian FDA review time
447 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K243255URIS Long Implant & AbutmentsTruabutment, Inc.2025-07-032610
K241485TruAbutment DS; TruBaseTruabutment, Inc.2024-10-091380
K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.2023-12-293110
K231874AOT & T-L AbutmentTruabutment, Inc.2023-10-301260
K213961TruAbutment DS, TruBaseTruabutment, Inc.2022-07-142060
K203649TruAbutment DS, TruBaseTruabutment, Inc.2021-09-152750
K202579TruAbutment DS, TruBaseTruabutment, Inc.2021-07-083030
K201842TruBase STruabutment, Inc.2021-06-043330
K201197TruAbutment DS, TruBase STruabutment, Inc.2021-03-263260
K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.2020-10-071910
K191913TruAbutment DSTruabutment, Inc.2020-06-193380
K183106TruAbutment DSTruabutment, Inc.2020-01-294470
K171532TruBase STruabutment, Inc.2018-09-114740
K172100URIS OMNI SystemTruabutment, Inc.2018-05-042970
K172304TruAbutment DSTruabutment, Inc.2018-01-231760

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