PARAGON

Alloy, Amalgam

LANCER ORTHODONTICS, INC.

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

Pre-market Notification Details

• Device ID: K991481
• 510k Number: K991481
• Device Name: PARAGON
• Classification: Alloy, Amalgam
• Applicant: LANCER ORTHODONTICS, INC. 253 PAWNEE ST. San Marcos, CA 92069
• Contact: Douglas D Miller
• Correspondent: Douglas D Miller; LANCER ORTHODONTICS, INC. 253 PAWNEE ST. San Marcos, CA 92069
• Product Code: EJJ
• CFR Regulation Number: 872.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-04-28
• Decision Date: 1999-08-11