Toothbrush, Manual
Dental · 21 CFR 872.6855
Recent MDR events
1,544 adverse event reports on file
- GUM PROXABRUSH GO-BETWEENS CLEANERS MODERATEJul 14, 2026MalfunctionSunstar Americas, Inc.1413787-2026-00298
- GUM ORTHODONTIC TRAVEL TOOTHBRUSHJul 7, 2026MalfunctionSunstar Americas, Inc.1413787-2026-00297
- GUM TECHNIQUE DEEP CLEANJun 25, 2026MalfunctionSunstar Americas, Inc.1413787-2026-00296
- TEPE IDB GREENJun 18, 2026MalfunctionTepe Munhygienprodukter Ab3003761382-2026-00003
- TEPE INTERDENTAL BRUSH ANGLE GREENJun 18, 2026MalfunctionTepe Munhygienprodukter Ab3003761382-2026-00002
- COL TB CLASSIC MEDIUMJun 17, 2026Injury3003205012-2026-00003
- GUM MULTI-CLEAN TOOTHBRUSHJun 8, 2026MalfunctionSunstar Americas, Inc.1413787-2026-00294
- GUM TECHNIQUE DEEP CLEAN SOFTJun 8, 2026MalfunctionSunstar Americas, Inc.1413787-2026-00295
- PROXAHANDLEMay 27, 2026MalfunctionSunstar Americas, Inc.1413787-2026-00288
- GUM MULTI-CLEAN TOOTHBRUSHMay 27, 2026MalfunctionSunstar Americas, Inc.1413787-2026-00289
Event type breakdown
Recalls
5 recall events for this product code
- GOLD STAR DISTRIBUTION INCOpen, ClassifiedJan 27, 2026
Toothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT; COLGATE TOOTH BRUSH MED. 12CT; ADULT TOOTHPASTE W BRUSH (WHITENING) 6.4oz/24ct; ADULT TOOTH
Potential exposure of rodents and rodent activity in the distribution center.
Z-1183-2026 · View FDA record ↗ - Family Dollar Stores, Llc.Open, ClassifiedAug 17, 2022
TRVL KIT TOTHBRSH CAP PASTE IN POUCH 1CT, SKU 900737
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Z-1535-2022 · View FDA record ↗ - Fridababy LLCOpen, ClassifiedJan 30, 2020
fridababy SmileFrida the TOOTHHUGGER
FridaBaby has been made aware through customer reports that the product is being used outside of the labeled directions. Specifically, repeated chewing or biting on the SmileFrida, the ToothHugger has caused deterioration in the outer layer of the brush and in very rare occasions, may cause the hard plastic brush head to break, exposing a small metal piece welded inside the brush head.
Z-1103-2020 · View FDA record ↗ - Norwex Usa IncTerminatedFeb 26, 2015
Manual Toothbrush; SilverCare Junior 2/6 years Antibacterial Toothbrush Made in Italy
The toothbrush head can potentially disengage from the handle.
Z-1213-2015 · View FDA record ↗ - Del Laboratories Inc.TerminatedAug 3, 2005
Orajel toddler EXTRA GENTLE Yellow Manual Toothbrush, Model 7531. Made in China --- The toothbrush is to be replaced every 3 months. --- Firm on label: DEL PHAR
Firm received several consumer complaints that the elastomer head of the toothbrush had separated (broke) from the handle during use and could pose a choking hazard to children.
Z-1082-05 · View FDA record ↗
Registered firms
597 firms currently registered for this product code
Drnoah Us Inc
Fullerton, CA, US
Yangzhou Yangchen Daily Expenses Factory
Yangzhou Jiangsu, CN
Moon Oral Care, Llc.
El Segundo, CA, US
Hood Container Corporation
Rural Hall, NC, US
Tung Hing Plastic & Metal(shenzhen) Co. Ltd.
LONGGANG DIST, SHENZHEN Guangdong, CN
Talbot's Pharmaceuticals Family Products Llc
Monroe, LA, US
Smart Technology Co., Ltd.
Foshan Guangdong, CN
Snagatr (fujian) Oral Health Technology Co., Ltd.
Zhangzhou Fujian, CN
Johnny Vico Infant & Gift Products (china )co, Ltd.
Shenzhen Guangdong, CN
Tender Corporation
Littleton, NH, US
Fansheng Technology (guangdong) Co., Ltd .
Zhongshan City Guangdong, CN
Labchem Sdn. Bhd
PETALNG JAYA Selangor, MY
Tianchang Roujie Brushing Industry Co., Ltd.
Tianchang Anhui, CN
Welltooth Co., Ltd.
Paju-si Gyeonggi, KR
Navajo Manufacturing Company
Denver, CO, US
Bamboo India Private Limited
Near Pimpri Pune Maharashtra, IN
Kin Sun Industrial Ltd.
Kowloon, HK
Foshan Dragon Industry Co., Ltd.
Foshan City Guangdong, CN
Global Dent Aids Private Limited
NOIDA Uttar Pradesh, IN
Yamato Esulon (thailand) Co.,ltd.
Bangpakong Chachoengsao, TH
Charm-tex
Brooklyn, NY, US
Lunarsea Personal Care Supplies Sdn. Bhd
PUNCAK ALAM Selangor, MY
Ipb Inc
Ogden, UT, US
Koln&shift Private Limited
TripleOne Somerset South East, SG
Maxill, Inc.
ST. THOMAS Ontario, CA
510(k) clearances
49 clearances for this product code
- Den Tek Oral Care, Inc.Jul 15, 2013
K130186 · DENTEK EASY BRUSH WITH FLUORIDE
- Beam Technologies, LLCJun 21, 2012
K121165 · BEAM BRUSH/BEAM APP
- Piave Spazzolificio S.P.A.Oct 3, 2011
K102871 · SILVER CARE ANITBACTERIAL TOOTHBRUSH
- Procter & GambleFeb 6, 2008
K073224 · ORAL-B SUB-BRAND MANUAL TOOTHBRUSH
- Agion Technologies, LLCJul 17, 2002
K021383 · ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL
- Coronet Group North America, LLCJun 3, 2002
K020776 · MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS
- Biolase Technology, Inc.Apr 14, 2000
K000290 · LAZERSMILE, LAZERWHITE
- Cal Huech, Inc.Mar 2, 2000
K994144 · TOOTHBRUSH WASH