LUXAGLAZE

Coating, Filling Material, Resin

DMG USA, INC.

The following data is part of a premarket notification filed by Dmg Usa, Inc. with the FDA for Luxaglaze.

Pre-market Notification Details

• Device ID: K013179
• 510k Number: K013179
• Device Name: LUXAGLAZE
• Classification: Coating, Filling Material, Resin
• Applicant: DMG USA, INC. 414 SOUTH STATE ST. Dover, DE 19901
• Contact: Pamela Papineau
• Correspondent: Pamela Papineau; DMG USA, INC. 414 SOUTH STATE ST. Dover, DE 19901
• Product Code: EBD
• CFR Regulation Number: 872.3310 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-09-24
• Decision Date: 2001-10-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
EDMG2120751	K013179	000