Atlas FDA

EMJ

6 FDA 510(k) clearances · Product code

47 daysmedian time to decision
52 days90th percentile
6clearances measured

FDA profile

Official device name
Elevator, Surgical, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4565
Medical specialty
Dental
Adverse events (MAUDE)
2020: 39 · 2021: 65 · 2022: 46 · 2023: 45 · 2024: 27 · 2025: 43
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ELEVATOR, ROOT, SINGLE-ENDED (K870589)Military Engineering, Inc.1987-04-03
880/1 TO 890/4 VARIOUS TYPES OF PERIOTEAL ELEVATOR (K851717)Artiberia1985-06-14
680/1 TO 785/2 VARIOUS TYPES & SIZES OF ROOT ELEVA (K851713)Artiberia1985-06-11
TACTILE PLUS DENTAL ELEVATORS (K850906)Ipco Corp.1985-04-12
BEACH DERIOSTEAL ELEVATOR, #2 STRAIGHT (K821788)Pacific Dental Corp.1982-07-06
PERIOSTEAL ELEVATOR (K771747)Depuy, Inc.1977-09-28

Track EMJ automatically

Every clearance here is in the API, with alerts when new ones post.