Oral Irrigation Kit
Dental · 21 CFR 872.6510
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
Recent MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
14 firms currently registered for this product code
Sterigenics U.s., Llc
Charlotte, NC, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Discus Dental, Llc
Ontario, CA, US
Isomedix Operations Inc
El Paso, TX, US
Shenzhen Fox Hunting E-commerce Co., Ltd
Shenzhen Guangdong, CN
Isomedix Operations Inc
EL PASO, TX, US
Wenzhou Zuoyou Medical Technoloyg Co.,ltd.
Wenzhou Zhejiang, CN
Border Assembly S. De R.l De C.v.
Tijuana Baja California, MX
Cardinal Health 200, Llc
Waukegan, IL, US
Philips Oral Healthcare, Llc
Bothell, WA, US
Hangzhou Yunchi Technology Co., Ltd
Hangzhou Zhejiang, CN
Cardinal Health 200, Llc
El Paso, TX, US
Sterigenics Us Llc
Grand Prairie, TX, US
Aimi Health Technology (guangdong) Co., Ltd.
Dongguan City Guangdong, CN
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.