Unit, Ultraviolet Sanitation/sterilization (for Toothbrushes), Sterile

Device Code: 1317

Product Code(s): MCF

Device Classification Information

Device Type ID1317
Device NameUnit, Ultraviolet Sanitation/sterilization (for Toothbrushes), Sterile
Regulation DescriptionManual Toothbrush.
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 Number872.6855 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeMCF
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1317
DeviceUnit, Ultraviolet Sanitation/sterilization (for Toothbrushes), Sterile
Product CodeMCF
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionManual Toothbrush.
CFR Regulation Number872.6855 [🔎]
Recalls
Manufacturer Recall Class Date Posted
1
Ceg Enterprises Llc
II Jun-23-2016
TPLC Last Update: 2019-04-02 19:51:54

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