Evacuator, Oral Cavity

Device Code: 1179

Product Code(s): EHZ

Device Classification Information

Device Type ID1179
Device NameEvacuator, Oral Cavity
Regulation DescriptionDental Operative Unit And Accessories.
Regulation Medical SpecialtyDental
Review PanelDental
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type510(K) Exempt
CFR Regulation Number872.6640 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeEHZ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID1179
DeviceEvacuator, Oral Cavity
Product CodeEHZ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionDental Operative Unit And Accessories.
CFR Regulation Number872.6640 [🔎]
Device Problems
Material Separation
1
Total Device Problems 1
TPLC Last Update: 2019-04-02 19:49:28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.