ORTHODONTIC BONDING ADHESIVE CONTROL

Adhesive, Bracket And Tooth Conditioner, Resin

LANCER ORTHODONTICS, INC.

The following data is part of a premarket notification filed by Lancer Orthodontics, Inc. with the FDA for Orthodontic Bonding Adhesive Control.

Pre-market Notification Details

• Device ID: K904090
• 510k Number: K904090
• Device Name: ORTHODONTIC BONDING ADHESIVE CONTROL
• Classification: Adhesive, Bracket And Tooth Conditioner, Resin
• Applicant: LANCER ORTHODONTICS, INC. 6050 AVENIDA ENCINAS P.O. BOX 819 Carlsbad, CA 92008
• Contact: Mike Ekinaka
• Correspondent: Mike Ekinaka; LANCER ORTHODONTICS, INC. 6050 AVENIDA ENCINAS P.O. BOX 819 Carlsbad, CA 92008
• Product Code: DYH
• CFR Regulation Number: 872.3750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-09-06
• Decision Date: 1991-04-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817573022892	K904090	000
00817573023264	K904090	000
00817573023271	K904090	000
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