Rinse, Oral, Antibacterial (by Physical Means)
Dental · 21 CFR 872.5580
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.
Recent MDR events
29 adverse event reports on file
- WATER PIKSep 10, 2025MalfunctionWater Pik1712259-2025-00002
- PERIOSHIELD ORAL RINSENov 19, 2021InjurySunstar Americas, Inc.0001413787-2021-00013
- PERIOSHIELD ORAL RINSENov 19, 2021InjurySunstar Americas, Inc.0001413787-2021-00014
- PERIOSHIELDAug 27, 2021MW5103561
- PERIOSHIELDAug 27, 2021MW5103562
- GUM PERIO SHIELDAug 26, 2021InjuryMW5103524
- PERIOSHIELD ORAL RINSEJul 15, 2021Injury1413787-2021-00011
- PERIOSHIELD ORAL RINSEJul 12, 2021Injury1413787-2021-00010
- GUM - 1775R PERIOSHIELD ORAL HEALTH RINSE, 10 OUNCE BOTTLEJun 29, 2021InjuryMW5102204
- G.U.M. PERIOSHIELDJun 29, 2021InjuryMW5102209
Event type breakdown
Recalls
2 recall events for this product code
- Family Dollar Stores, Llc.Open, ClassifiedNov 7, 2023
ORAL B MOUTH SORE RINSE 237ML, SKU 999087
Products were stored outside of labeled temperature requirements.
Z-0270-2024 · View FDA record ↗ - Sunstar Americas, Inc.TerminatedUnknown
SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Signif
Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans.
Z-1837-2021 · View FDA record ↗
Registered firms
1 firms currently registered for this product code
510(k) clearances
2 clearances for this product code