DEMI

Activator, Ultraviolet, For Polymerization

KERR CORPORATION

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

Pre-market Notification Details

• Device ID: K071251
• 510k Number: K071251
• Device Name: DEMI
• Classification: Activator, Ultraviolet, For Polymerization
• Applicant: KERR CORPORATION 1717 WEST COLLINS AVENUE Orange, CA 92867
• Contact: Colleen Boswell
• Correspondent: Colleen Boswell; KERR CORPORATION 1717 WEST COLLINS AVENUE Orange, CA 92867
• Product Code: EBZ
• CFR Regulation Number: 872.6070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-05-04
• Decision Date: 2007-07-26
• Summary: summary