Atlas FDA

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

PEM — Predicate Candidate Screening

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

130 daysmedian FDA review time
203 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K250735Dental Barrier and SleevesFomed Industries, Inc.2025-06-10910
K250606Dental Barrier and SleevesYueying Medical Instruments (Langfang) Co., Ltd.2025-05-29900
K242435Dental Barrier and SleevesWellmed Dental Medical Supply Co., Ltd.2024-10-18630
K233918Dental Barrier and SleevesYongqing Huaguan Dental Instruments Factory2024-05-091480
K220662Disposable Barrier SleevesPremium Plus (Dongguan) Limited2022-05-11650
K211026Minitube Dentasleeve Protective Barrier SleevesMinitube AB2021-08-031190
K201604Plasdent Disposable Barrier Sleeves and Barrier FilmPlasdent Corporation2020-12-231910
K191448Barrier SleevesIvoclar Vivadent, AG2019-10-081300
K190484BH Medical Dental Barrier Sleeves and Barrier FilmBh Medical Products Co., Ltd.2019-09-101950
K190949ScanX Barrier EnvelopesAir Techniques, Inc.2019-07-261060
K183263UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE BarrierUnipack Medical Corporation2019-06-142030
K163447Premium Plus Disposable Barrier SleevePremium Plus International Limited2017-06-201940
K160232Disposable Barrier Sleeves and CoversDentsply International, Inc.2016-06-071270
K151123Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier FilmPac-Dent International, Inc.2016-03-033100
K132953TIDISHEILDTidi Products,Llc2014-02-181510

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