Unit, Suction Operatory

Device Code: 1128

Product Code(s): EBR

Device Classification Information

Device Type ID1128
Device NameUnit, Suction Operatory
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 CodeEBR
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 ID1128
DeviceUnit, Suction Operatory
Product CodeEBR
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionDental Operative Unit And Accessories.
CFR Regulation Number872.6640 [🔎]
TPLC Last Update: 2019-04-02 19:48:46

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