Pick, Massaging
Dental · 21 CFR 872.6650
Recent MDR events
100 adverse event reports on file
- SOFT-PICKS ADVANCEDJun 3, 2026MalfunctionSunstar Americas, Inc.1413787-2026-00293
- SOFT-PICKS ORIGINALMay 27, 2026MalfunctionSunstar Americas, Inc.1413787-2026-00290
- SOFT-PICKS ADVANCEDMay 27, 2026MalfunctionSunstar Americas, Inc.1413787-2026-00292
- GUM SOFT-PICKS ADVANCEDApr 24, 2026MalfunctionSunstar Americas, Inc.1413787-2026-00283
- SOFT-PICKS ORIGINALMar 10, 2026MalfunctionSunstar Americas, Inc.1413787-2026-00270
- SOFT-PICKS ORIGINALFeb 24, 2026MalfunctionSunstar Americas, Inc.1413787-2026-00262
- SOFT-PICKS ADVANCEDFeb 16, 2026MalfunctionSunstar Inc1413787-2026-00257
- GUM SOFT-PICKS ORIGINAL 50 CTFeb 11, 2026MalfunctionSunstar Americas, Inc.1413787-2026-00255
- GUM® SOFT-PICK® ORIGINAL 80CTOct 22, 2025InjurySunstar Americas, Inc.1413787-2025-00239
- GUM® SOFT-PICKS® ADVANCEDOct 9, 2025MalfunctionSunstar Americas, Inc.1413787-2025-00236
Event type breakdown
Recalls
2 recall events for this product code
- Young Dental Manufacturing I, LLCOpen, ClassifiedDec 19, 2022
Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714
mislabeled product
Z-0725-2023 · View FDA record ↗ - Water Pik, Inc.TerminatedUnknown
Waterpik Sonic-Fusion Professional, Model: SF-02
Charging base may overheat with localized melting and sparking, possibly causing fire, shock or burns.
Z-2734-2018 · View FDA record ↗
Registered firms
129 firms currently registered for this product code
Ningbo Aolbea Oral Care Products Co., Ltd
Yuyao City Zhejiang, CN
Industrias Apson S.a De C.v
AGUA PRIETA Sonora, MX
Pacific Care Limited / Pacificare Asia Limited
Hong Kong, HK
Ranir Llc
Grand Rapids, MI, US
Changzhou Freshday Household Products Corp. Ltd.
Changzhou Jiangsu, CN
Acumen Houseware Industry (vietnam) Co., Ltd
Thuan An City Binh Duong, VN
Weihai Jieshi Commodity Manufacture Co. Ltd.
WEIHAI,SHANDONG, CN
Allmed Industrial Limited
Shenzhen City Guangdong, CN
Acumen Houseware Industry (nanning) Co., Ltd.
NANNING Guangxi, CN
New Phenix Home Products Manufactory Co., Ltd.
YANGZHOU Jiangsu, CN
M + C Schiffer Gmbh
NEUSTADT/WIED Rhineland-Palatinate, DE
Tess Oral Health Llc
EAU CLAIRE, WI, US
Thaimed Hightech Co.,ltd.
Kabinburi Prachin Buri, TH
Shandong Richsource Biological Technology Co.,ltd
Jining Shandong, CN
Lg H&h Co., Ltd.
Seoul, KR
Oketz Logistics Llc
Coral Gables, FL, US
Natural Dentist Llc
Buena Park, CA, US
Jome Commodity Co.,ltd.
Ningbo Zhejiang, CN
Sunstar Americas, Inc.
Schaumburg, IL, US
Placecol S.a
funza Cundinamarca, CO
Den-mat Holdings, Llc
Lompoc, CA, US
Phoenix Instruments, Inc.
Lisle, IL, US
Yangzhou Royal Home Products Manufacture Co., Ltd.
Yangzhou Jiangsu, CN
Yangzhou Haiwang Toothbrush Factory
Yangzhou Jiangsu, CN
Yangzhou Gaoyuan Daily Chemicals Co.,ltd.
Yangzhou Jiangsu, CN
510(k) clearances
15 clearances for this product code
- Whitehill Manufacturing, Inc.Dec 16, 1996
K963747 · REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODENT/REACH FLOSS PICS WITH MICRODENT ETC.
- Oral-B LaboratoriesApr 27, 1995
K942633 · ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE
- Arizona Implant DentistryJul 28, 1993
K930178 · ELECTRO FLOSS
- Burn-Henderson PartnershipJul 17, 1991
K911418 · GUM MASSAGER
- Dentek Corp.Mar 17, 1989
K885189 · MASSAGING PICK FOR ORAL HYGIENE
- Ximex, Ltd.Mar 16, 1989
K890910 · PLAKOF
- Richard G. DeniroAug 30, 1988
K883225 · FLOSSIE
- The Perma-Pic Co.Jun 1, 1988
K881900 · PERMA-PIC PLASTIC TOOTHPICK