FDA 510(k), K030036, TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT

FDA 510(k), K030036, TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT

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510(K) Number: K030036
Device Name: TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT
Manufacturer: KENNETH J BERK
Device Classification Name: Adhesive, Bracket And Tooth Conditioner, Resin
Regulation Number: DYH
Classification Product Code: KXA
Date Received: 01/03/2003
Decision Date: 03/12/2003
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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