Atlas FDA

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

NTK — Predicate Candidate Screening

12 FDA 510(k) clearances under this product code; the 50 most recent screened below.

142 daysmedian FDA review time
323 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261847iTero Lumina™ ProAlign Technology , Ltd.2026-07-02290
K250771Primescan 2Dentsply Sirona, Inc.2025-08-291690
K240573iTero Lumina™ ProAlign Technology , Ltd.2024-08-161680
K213482TIA Tip, Cariosity, Transillumination Accessory TipD4D Technologies, LLC2022-04-291820
K193659iTero Element 5DAlign Technology, Inc.2020-03-20810
K182712DEXIS CariVu 3-in-1 by KaVoKaltenbach & Voigt GmbH2019-11-234220
K172007CamX Triton HD Proxi HeadDuerr Dental AG2017-11-221420
K123402DIAGNOCAMKaltenbach & Voigt GmbH2013-09-243230
K071429TI2200 TRANSILLUMINATION CABLEKerr Corporation2007-09-101100
K062961MICROLUX TRANSILLUMINATORAddent, Inc.2007-02-081320
K060080DIAGNODENT 2190 WITH PERIODONTAL PROBEKavo Dental Corporation2006-02-08290
K043068DIFOTI USB 2.0 SYSTEMElectro-Optical Sciences, Inc.2004-12-29510

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