ENDURE

Alloy, Gold-based Noble Metal

AALBA DENT, INC.

The following data is part of a premarket notification filed by Aalba Dent, Inc. with the FDA for Endure.

Pre-market Notification Details

• Device ID: K950310
• 510k Number: K950310
• Device Name: ENDURE
• Classification: Alloy, Gold-based Noble Metal
• Applicant: AALBA DENT, INC. 400 WATT DR. Cordelia, CA 94534
• Contact: Vincent Benetti
• Correspondent: Vincent Benetti; AALBA DENT, INC. 400 WATT DR. Cordelia, CA 94534
• Product Code: EJT
• CFR Regulation Number: 872.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-01-25
• Decision Date: 1995-02-16