U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Material, tooth shade, resin - Product Code EBF
원인
A recall was initiated because pentron clinical has confirmed that the fusio liquid dentin is not as flowable as ideally expected.
조치
Pentron Clinical sent a Medical Device Recall letter dated September 8, 2010 (via USPS 1st class mail) to all affected customers. The letter identified the affected product, the reason for the recall and the actions to be taken. Customers were instructed to examine their inventory for the affected product, return any remaining in stock and complete and fax back the enclosed recall return form. Customers were advised to contact Pentron Clinical Customer Service at (800) 551-0283, (option 1) directly to handle the arrangements of a quick return and replacement.
Worldwide Distribution - USA (nationwide) in the countries of Austria, Bulgaria, France, Great Britain, Netherlands, Japan, Lebanon, Malaysia and South Africa.
제품 설명
Brand Name: Fusio Liquid Dentin, part number N21SB, N21SC. || Product Usage: || The intended use of this device is as a self-etch, self-adhesive flowable resin composite indicated for light-cured dental restorations. Applications include self-etch base liner, restorations of carious lesions, Class I, III and V cavity preparations and pitt and fissure sealant.