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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device rinse, oral, antibacterial (by physical means)
Regulation Description Oral rinse to reduce the adhesion of dental plaque.
Definition Antibacterial oral rinse that is used as an aid in the treatment of gingivitis, acting by physical rather than chemical means. The rinse works by coating tooth and tissue surfaces, providing a positive charge that reduces bacterial adhesion.
Product CodeNTO
Regulation Number 872.5580
Device Class 2

MDR Year MDR Reports MDR Events
2020 1 1
2021 23 34
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Nonstandard Device 14 25
Patient-Device Incompatibility 6 6
Contamination 3 3
Microbial Contamination of Device 2 2
Patient Device Interaction Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Product Quality Problem 1 1
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 6 8
No Clinical Signs, Symptoms or Conditions 4 13
Dyspnea 4 4
Unspecified Infection 3 3
Nausea 2 2
Numbness 2 2
Chest Pain 2 2
Cough 2 2
Hypoxia 2 2
Unspecified Respiratory Problem 2 2
Bacterial Infection 2 2
Skin Infection 1 1
Skin Inflammation/ Irritation 1 1
Taste Disorder 1 1
Inflammation 1 1
Local Reaction 1 1
Skin Disorders 1 1
Fever 1 1
Rash 1 1
Discomfort 1 1
Pain 1 1
Pneumonia 1 1
Swelling/ Edema 1 1
Ulcer 1 1
Sore Throat 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Low Oxygen Saturation 1 1
Sensitivity of Teeth 1 1
Respiratory Failure 1 1
Increased Sensitivity 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Family Dollar Stores, Llc. II Nov-07-2023
2 Sunstar Americas, Inc. II Jun-09-2021
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