DURASHIELD PLUS

Varnish, Cavity

DENTSPLY INTL., INC.

The following data is part of a premarket notification filed by Dentsply Intl., Inc. with the FDA for Durashield Plus.

Pre-market Notification Details

• Device ID: K082198
• 510k Number: K082198
• Device Name: DURASHIELD PLUS
• Classification: Varnish, Cavity
• Applicant: DENTSPLY INTL., INC. SUSQUEHANNA COMMERCE CENTER 221 W PHILADELPHIA ST. STE 60 York, PA 17404
• Contact: Helen Lewis
• Correspondent: Helen Lewis; DENTSPLY INTL., INC. SUSQUEHANNA COMMERCE CENTER 221 W PHILADELPHIA ST. STE 60 York, PA 17404
• Product Code: LBH
• CFR Regulation Number: 872.3260 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-08-04
• Decision Date: 2008-10-29
• Summary: summary