Endodontic Kit
Dental · 21 CFR 872.3820
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
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
1 recall events for this product code
Registered firms
11 firms currently registered for this product code
Sterigenics Us Llc
Grand Prairie, TX, US
Dental Engineering Laboratories, Llc
Goleta, CA, US
Tulsa Dental Products Llc
Johnson City, TN, US
Isomedix Operations Inc
El Paso, TX, US
Brasseler U.s.a. Dental, Llc
SAVANNAH, GA, US
Isomedix Operations Inc
EL PASO, TX, US
Guilin Woodpecker Medical Instrument Co., Ltd
GUILIN CITY Guangxi, CN
Cardinal Health 200, Llc
El Paso, TX, 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
Waukegan, IL, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.