METAMORPHOSIS

Material, Tooth Shade, Resin

KERR CORPORATION

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

Pre-market Notification Details

• Device ID: K091023
• 510k Number: K091023
• Device Name: METAMORPHOSIS
• Classification: Material, Tooth Shade, 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: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-04-10
• Decision Date: 2009-05-21
• Summary: summary