EHZClass I

Evacuator, Oral Cavity

Dental · 21 CFR 872.6640

MDR events9All time

Recalls1All time

Registered firms142Currently listed

510(k) clearances17All time

Recent MDR events

9 adverse event reports on file

ANGLED DUAL AXIS SWIVEL ADAPTERApr 18, 2024
MalfunctionSmiths Medical Asd, Inc.1217052-2024-00009
HVE (HIGH VOLUME EVACUATOR) TIPSDec 1, 2023
MalfunctionSpsmedical Supply Corp. A Div. Of Crosstex Intl.1319130-2023-00014
HVE VALVE CLEANING BRUSHApr 5, 2021
InjuryDte Oregon, Inc. Dba Forest Dental / Forest Dental EquipmentMW5100568
SURG-O-VAC ASPIRATION TIP DENTALMar 16, 2020
Young Dental Manufacturing Co I, Llc.MW5093776
COMBO-TIP EVACUATOROct 24, 2018
InjuryCrosstex International Inc.3006008984-2018-00001
EXTENDED CARE SUCTION SWAB KIT WITH BIOTENE (DENTIP ORAL SWAB)Dec 13, 2017
MalfunctionMedline Industries7112368
REF MD5096513Feb 27, 2013
InjuryMedline Industries IncMW5029226
SCHEIN DENTAL ULTIMA 5000 II SEAug 21, 2001
MalfunctionUltima Dental SystemsMW4003116
ASPIRATORY DENTALApr 17, 1995
InjuryKent Dental22137

Event type breakdown

Injury4

Malfunction4

Unspecified1

Most-reported manufacturers

Crosstex International Inc.1 Dte Oregon, Inc. Dba Forest Dental / Forest Dental Equipment1 Kent Dental1 Medline Industries1 Medline Industries Inc1 Smiths Medical Asd, Inc.1 Spsmedical Supply Corp. A Div. Of Crosstex Intl.1 Ultima Dental Systems1

Recalls

1 recall events for this product code

Stradis Medical, LLC dba Stradis Healthcare
Open, ClassifiedDec 14, 2022
STRADIS HEALTHCARE, TIP, SURGE-O-VAC .125" GREEN, Item No.SS077225,
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Z-0558-2023 · View FDA record ↗

Registered firms

142 firms currently registered for this product code

510(k) clearances

17 clearances for this product code