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
Agent, tooth bonding, resin - Product Code KLE
원인
The recall was initiated because pentron clinical has confirmed that various lots of bond-1 primer/adhesive have been found to have gelled and therefore becomes unusable.
조치
Pentron Clinical sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 7, 2010 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were instructed to complete and return an enclosed Recall Return Form via fax at 1-877-677-8844. 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) and the countries of Germany, Canada, Ecuador, Egypt, Hong Kong, India, Israel, Japan, Kenya, Lebanon, Morocco, Saudi Arabia, Singapore, El Salvador, Thailand, Turkey, Taiwan, UAE, Vietnam, Armenia, Austria, Belgium, Bulgaria, Byelorussia, Cyprus, Germany, Spain, Russia, Finland, England, Greece, Hungary, Ireland, Italy, Latvia, Netherlands, Poland, Romania, Sweden, and Serbia.
제품 설명
Brand name: Bond-1 Primer/Adhesive, a resin tooth bonding || agent. || Item # Item Description || N01I Bond-1 Prim/Adhesive Kit || N01IAA Bond-1 Primer/Adhesive 4ml || N01IAB Bond-1 Primer/Adhesive 6ml || N04 Lute-it w/ Bond-1 kit || N04B Lute-t w/Bond-1 Intro Kit || N31B Bond-1 C&B; Prim/Adhesive || N33 Cement-it Universal C&B; Resin. || The intended use of this device is adhesion to dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi-precious and non-precious alloys, porcelain and glass and luting of same to Dentin and Enamel.