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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: 01/03/2003
Date Received: 03/12/2003
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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: 01/03/2003
Date Received: 03/12/2003
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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