CERAPALL

Alloy, Other Noble Metal

METALOR DENTAL USA CORP.

The following data is part of a premarket notification filed by Metalor Dental Usa Corp. with the FDA for Cerapall.

Pre-market Notification Details

• Device ID: K911670
• 510k Number: K911670
• Device Name: CERAPALL
• Classification: Alloy, Other Noble Metal
• Applicant: METALOR DENTAL USA CORP. 457 LAUREL RD. BOX 369 Rockville Centre, NY 11571 -0369
• Contact: Brian Schiller
• Correspondent: Brian Schiller; METALOR DENTAL USA CORP. 457 LAUREL RD. BOX 369 Rockville Centre, NY 11571 -0369
• Product Code: EJS
• CFR Regulation Number: 872.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-04-11
• Decision Date: 1991-06-18