Light, Fiber Optic, Dental

Device Code: 1115

Product Code(s): EAY

Device Classification Information

Device Type ID1115
Device NameLight, Fiber Optic, Dental
Regulation DescriptionFiber Optic Dental Light.
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 Number872.4620 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeEAY
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1115
DeviceLight, Fiber Optic, Dental
Product CodeEAY
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionFiber Optic Dental Light.
CFR Regulation Number872.4620 [🔎]
TPLC Last Update: 2019-04-02 19:48:35

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