FDA 510(k) K123396, I.FLEX BY TCS, by Thermoplastic Comfort Systems, Inc.
FDA 510(k) K123396, I.FLEX BY TCS, by Thermoplastic Comfort Systems, Inc.
Device Name: I.FLEX BY TCS
Manufacturer: Thermoplastic Comfort Systems, Inc.
Device Classification Name: Resin, Denture, Relining, Repairing, Rebasing
Regulation Number: 872.3760
Classification Product Code: EBI
Date Received: 11/05/2012
Decision Date: 01/10/2013
Regulation Medical Specialty: Dental
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