INTEGRITY

Crown And Bridge, Temporary, Resin

DENTSPLY INTL.

The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Integrity.

Pre-market Notification Details

• Device ID: K853052
• 510k Number: K853052
• Device Name: INTEGRITY
• Classification: Crown And Bridge, Temporary, Resin
• Applicant: DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405
• Contact: John O Semmelman
• Correspondent: John O Semmelman; DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405
• Product Code: EBG
• CFR Regulation Number: 872.3770 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-07-19
• Decision Date: 1985-08-16