CERAMIC PEDATRIC PREFORMED CROWN

Crown, Preformed

EZ-PEDO INC

The following data is part of a premarket notification filed by Ez-pedo Inc with the FDA for Ceramic Pedatric Preformed Crown.

Pre-market Notification Details

• Device ID: K091362
• 510k Number: K091362
• Device Name: CERAMIC PEDATRIC PREFORMED CROWN
• Classification: Crown, Preformed
• Applicant: EZ-PEDO INC 2350 PROFESSIONAL DRIVE SUITE 200 Roseville, CA 95661
• Contact: Jeffrey Fisher
• Correspondent: Jeffrey Fisher; EZ-PEDO INC 2350 PROFESSIONAL DRIVE SUITE 200 Roseville, CA 95661
• Product Code: ELZ
• CFR Regulation Number: 872.3330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-05-08
• Decision Date: 2009-06-29
• Summary: summary

NIH GUDID Devices

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