Heat Source For Bleaching Teeth
Dental · 21 CFR 872.6475
Recent MDR events
85 adverse event reports on file
- SO BRILLIANT TEETH WHITENING KITAug 7, 2025InjuryGlo Science Inc.MW5174175
- SO BRILLIANT TEETH WHITENING KITAug 7, 2025InjuryGlo Science Inc.MW5174176
- SO BRILLIANT TEETH WHITENING KITAug 7, 2025InjuryGlo Science, Inc.MW5174177
- SO BRILLIANT TEETH WHITENING KITAug 7, 2025InjuryGlo Science, Inc.MW5174178
- BRIGHTBYTE PRO WHITENING KITMay 21, 2025InjuryJiangxi Dentalbright Tech Co., Ltd3031789024-2025-02567
- SO BRILLIANT WHITENING KITFeb 10, 2025InjuryGlo Science, Inc.3008475975-2025-00001
- GLO SCIENCE'S SO BRILLIANT WHITENING KITJan 9, 2025InjuryGlo Science, Inc.MW5164538
- PHILIPSFeb 15, 2024InjuryDiscus Dental, Llc2031532-2024-00001
- BRIGHT ON PREMIUM TEETH WHITENING KITSep 30, 2022InjurySmiledirectclub S.aMW5112374
- LED LIGHTJan 7, 2022MalfunctionAccess Dental Lab3014658399-2021-01817
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
116 firms currently registered for this product code
Shanghai Lansheng Light Industrial Products Imp & Exp Corp Ltd
Shanghai, CN
Ekong Technology Co., Limited.
Shenzhen Guangdong, CN
Wsd Labs Usa Inc
Tonawanda, NY, US
Moon Oral Care, Llc.
El Segundo, CA, US
Dxm Co., Ltd.
Hwasun-gun Jeonnam, KR
Wuhan Zjzk Technology Co.,ltd. (aka Wuhan Zjkc Technology Co.,ltd.)
Wuhan Hubei, CN
Joicom Corporation
Eastvale, CA, US
Glo Science, Inc.
Garden Grove, CA, US
Shenzhen Fortunecome Technology Co.,ltd.
Shenzhen Guangdong, CN
Xplora Usa Llc
Carrollton, TX, US
The Beauty Tech Group Ltd
Macclesfield Cheshire East, GB
Shenzhen Balinda Technology Co.,ltd
Shenzhen Guangdong, CN
Foshan Ousidun Personal Care Products Co.,ltd
FOSHAN Guangdong, CN
Zhengzhou Huaer Electro-optics Technology Co., Ltd.
Zhengzhou Henan, CN
Foreo Inc
Las Vegas, NV, US
Whitesmile Gmbh
Birkenau Hesse, DE
Rolence Ent. Inc.
CHUNGLI Taoyuan, TW
Procter & Gamble Co., Regulatory Affairs
Mason, OH, US
Xingyue Medical Health Technology (nanjing) Co., Ltd .
Nanjing Jiangsu, CN
Ortho Dental Lab, Llc
Antioch, TN, US
Gigaalaser Company Ltd.
Wuhan Hubei, CN
Huizhou Gold Rose Technology Co.,ltd
huizhou Guangdong, CN
Dentamerica
City of Industry, CA, US
Samson Innovation Corp. Ltd.
KOWLOON, HK
Oketz Logistics Llc
Coral Gables, FL, US
510(k) clearances
12 clearances for this product code
- Syneron BeautyNov 27, 2012
K122725 · TANDA PEARL, ULTRAWYTE, PEARL
- Dr. Fresh, Inc.Jan 12, 2012
K110888 · ABSOLUTE WHITE LIGHT
- Beks IncorporatedFeb 20, 2007
K063704 · BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101
- Cosmetic Dental Materials, Inc.Oct 18, 2005
K052040 · QUICKSMILE
- Dentovations, Inc.Nov 8, 2004
K042153 · SOUTH BEACH SMILE LIGHT WHITENING SYSTEM
- CAO Group, Inc.Nov 8, 2004
K041392 · SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US
- Union Broach, Div. Moyco Industries, Inc.Apr 13, 1990
K895174 · UNION BROACH BLEACHING LIGHT
- Grass-Telefactor Product GroupApr 14, 1989
K884937 · BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING