Plaque Disclosing Kit
Dental · 21 CFR 872.1740
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
17 firms currently registered for this product code
Zhengzhou Huaer Electro-optics Technology Co., Ltd.
Zhengzhou Henan, CN
Cardinal Health 200, Llc
Waukegan, IL, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Sterigenics U.s., Llc
Charlotte, NC, US
Cardinal Health 200, Llc
El Paso, TX, US
Isomedix Operations Inc
El Paso, TX, US
Angelus Industria De Productos Odontologicos
LONDRINA Parana, BR
Guilin Yikeshi Medical Device Co Ltd
Guilin Guangxi, CN
Guangzhou Stars Pulse Co., Ltd.
Guangzhou Guangdong, CN
Satelec-acteon Group
MERIGNAC Gironde, FR
Nimi Chemical Industrial Co., Ltd.
Kiryu Gunma, JP
Sopro
LA CIOTAT CEDEX Bouches-du-Rhone, FR
Nomax, Inc.
Affton, MO, US
Dci International, Llc
NEWBERG, OR, US
Sterigenics Us Llc
Grand Prairie, TX, US
Isomedix Operations Inc
EL PASO, TX, US
Gc Corp.
ITABASHI-KU Tokyo, JP
510(k) clearances
1 clearances for this product code