Protector, Dental

Device Code: 1

Product Code(s): BRW

Device Classification Information

Device Type ID1
Device NameProtector, Dental
Regulation DescriptionDental Protector.
Regulation Medical SpecialtyAnesthesiology
Review PanelAnesthesiology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Anesthesiology Devices Branch (ANDB)
Submission Type510(K) Exempt
CFR Regulation Number868.5820 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeBRW
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1
DeviceProtector, Dental
Product CodeBRW
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionDental Protector.
CFR Regulation Number868.5820 [🔎]
TPLC Last Update: 2019-04-02 19:05:36

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