VARIFLEX

Resin, Denture, Relining, Repairing, Rebasing

GREAT LAKES ORTHODONTICS, LTD.

The following data is part of a premarket notification filed by Great Lakes Orthodontics, Ltd. with the FDA for Variflex.

Pre-market Notification Details

• Device ID: K033632
• 510k Number: K033632
• Device Name: VARIFLEX
• Classification: Resin, Denture, Relining, Repairing, Rebasing
• Applicant: GREAT LAKES ORTHODONTICS, LTD. 200 COOPER AVE.DR. Tonawanda, NY 14150
• Contact: Mark Lauren
• Correspondent: Mark Lauren; GREAT LAKES ORTHODONTICS, LTD. 200 COOPER AVE.DR. Tonawanda, NY 14150
• Product Code: EBI
• CFR Regulation Number: 872.3760 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-11-19
• Decision Date: 2004-01-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D7750460050	K033632	000
D7750460040	K033632	000
D7750460030	K033632	000
D7750460020	K033632	000
D7750460010	K033632	000