MAUClass I

Eraser, Dental Stain

Dental · 21 CFR 872.6855

MDR events8All time

Recalls1All time

Registered firms63Currently listed

510(k) clearances2All time

Recent MDR events

8 adverse event reports on file

WHITER IMAGE 40% PEROXIDEApr 22, 2024
MalfunctionPac-dent Inc.MW5154077
TEETH WHITENING GEL SYRINGEAug 15, 2023
MalfunctionFlorida Laboratories, Inc.MW5144628
CREST WHITENING EMULSIONS LEAVE-ON TEETH WHITENING KIT WITH WHITENINGFeb 1, 2022
InjuryCrest/impact Fulfillment ServicesMW5107119
ARC WHITENING SYSTEMS STRIPS + LIGHT WHITESTRIP 3D WHITE NO FLAVOR-SCENT * COUNTJan 6, 2021
InjuryThe Procter & Gamble CompanyMW5098712
GLEEM WHITENING SYSTEMS STRIPS + (CONTINUED)Sep 28, 2020
InjuryProcter & Gamble Co.MW5096910
GLEEM WHITENING SYSTEMS STRIPS+ LIGHT WHITESTRIP 3D WHITE NO FLAVOR-SCENT 14CT BSep 28, 2020
InjuryProcter & Gamble Co.MW5096911
TEETH WHITENING KITSep 24, 2020
MalfunctionUnkMW5096880
CRESTWHTNGSYSSTRIPS+LIGHTWHITESTRIP3DWHITENOFLAVORSCENTMay 21, 2018
InjuryProcter & Gamble Manufacturing Co.1530449-2018-00002

Event type breakdown

Injury5

Malfunction3

Most-reported manufacturers

Procter & Gamble Co.2 Crest/impact Fulfillment Services1 Florida Laboratories, Inc.1 Pac-dent Inc.1 Procter & Gamble Manufacturing Co.1 The Procter & Gamble Company1 Unk1

Recalls

1 recall events for this product code

Family Dollar Stores, Llc.
Open, ClassifiedNov 7, 2023
ARC TEETH WHITENING PEN 0.06 FL OZ, SKU 997950
Products were stored outside of labeled temperature requirements.
Z-0268-2024 · View FDA record ↗

Registered firms

63 firms currently registered for this product code

510(k) clearances

2 clearances for this product code