TEMPFLEX

Crown And Bridge, Temporary, Resin

KERR CORPORATION

The following data is part of a premarket notification filed by Kerr Corporation with the FDA for Tempflex.

Pre-market Notification Details

• Device ID: K110747
• 510k Number: K110747
• Device Name: TEMPFLEX
• Classification: Crown And Bridge, Temporary, Resin
• Applicant: KERR CORPORATION 1717 WEST COLLINS AVENUE Orange, CA 92867
• Contact: Wendy Garman
• Correspondent: Wendy Garman; KERR CORPORATION 1717 WEST COLLINS AVENUE Orange, CA 92867
• Product Code: EBG
• CFR Regulation Number: 872.3770 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-03-17
• Decision Date: 2011-06-14
• Summary: summary