ALPHA-DENT

Material, Impression

WALLACE A. ERICKSON & CO.

The following data is part of a premarket notification filed by Wallace A. Erickson & Co. with the FDA for Alpha-dent.

Pre-market Notification Details

• Device ID: K940120
• 510k Number: K940120
• Device Name: ALPHA-DENT
• Classification: Material, Impression
• Applicant: WALLACE A. ERICKSON & CO. 1920 N. CLYBOURN AVE. Chicago, IL 60614
• Contact: George Nicolae, Ph.d.
• Correspondent: George Nicolae, Ph.d.; WALLACE A. ERICKSON & CO. 1920 N. CLYBOURN AVE. Chicago, IL 60614
• Product Code: ELW
• CFR Regulation Number: 872.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-01-10
• Decision Date: 1994-02-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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00190707000394	K940120	000
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00190730004482	K940120	000