Atlas FDA

EHZ

17 FDA 510(k) clearances · Product code

65 daysmedian time to decision
82 days90th percentile
17clearances measured

FDA profile

Official device name
Evacuator, Oral Cavity
Device class
Class I (low risk)
Regulation
21 CFR 872.6640
Medical specialty
Dental
Adverse events (MAUDE)
1995: 1 · 2001: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
IMTEC BONE COLLECTOR SYSTEM (K973248)Imtec Corp.1997-11-19
TAP EXPRESS EJECTOR (K941164)Tap Express, Inc.1994-05-18
SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR (K911072)A & F Products1991-05-15
OROSCOPE MODEL NUMBER COS-100 (K903718)Cygnus Instruments, Inc.1990-11-09
DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102 (K892882)Nieusma R & D, Inc.1989-06-23
DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101 (K892881)Nieusma R & D, Inc.1989-06-23
DRI-CLAVE LIQUID KLEENZALL (K880754)Columbus Dental Mfg. Co.1988-05-12
PORTABLE FIELD DENTAL OPERATING & TREATMENT UNIT (K873545)Commercial Products & Engineering Co.1987-11-20
TITANIUM SUCTION TIP (K874401)Implant Innovations International, Inc.1987-11-12
VAC - RITE RIGHT ANGLE ASPIRATOR TUBE & HOLDER (K864621)Seldoren , Ltd.1987-02-13
EVACUATOR TIPS (K863769)The Medical Group, Inc.1986-10-30
SPACELINE HIGH VOLUME EVACUATION HANDPIE (K801682)Pacific Dental Corp.1980-08-04
MVS UNIT, MODEL SEU-8 AND DEU-8, 80 (K782068)Dentsply Intl.1979-01-26
MVS-MODEL SEU-6, DEU-6 (K781488)Dentsply Intl.1978-09-27
STERI-VAC POWER UNITS (K781486)Cpac, Inc.1978-09-27
DENTAL OFFICE ENVIRONMENT CONTROL UNIT (K780701)Laminaire Corp.1978-05-16
AUTO-RINSE (K770152)Dental Innovators, Inc.1977-01-31

Track EHZ automatically

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