Cleanser, Denture, Prescription

Device Code: 1359

Product Code(s): NUX

Definition: Effervescent Tablet For The Removal Of Micro-organisms From Removable Dentures And Retainers.

Device Classification Information

Device Type ID1359
Device NameCleanser, Denture, Prescription
Regulation DescriptionOTC Denture Cleanser.
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 Number872.3520 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeNUX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID1359
DeviceCleanser, Denture, Prescription
Product CodeNUX
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionOTC Denture Cleanser.
CFR Regulation Number872.3520 [🔎]
TPLC Last Update: 2019-04-02 19:52:41

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