TCS Blend

Resin, Denture, Relining, Repairing, Rebasing

Thermoplastic Comfort Systems, Inc.

The following data is part of a premarket notification filed by Thermoplastic Comfort Systems, Inc. with the FDA for Tcs Blend.

Pre-market Notification Details

• Device ID: K142894
• 510k Number: K142894
• Device Name: TCS Blend
• Classification: Resin, Denture, Relining, Repairing, Rebasing
• Applicant: Thermoplastic Comfort Systems, Inc. 2619 Lime Avenue Signal Hill, CA 90755
• Contact: Marilin Posca
• Correspondent: Marilin Posca; Thermoplastic Comfort Systems, Inc. 2619 Lime Avenue Signal Hill, CA 90755
• Product Code: EBI
• CFR Regulation Number: 872.3760 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-10-03
• Decision Date: 2015-02-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D8052002JPS42	K142894	000
D805200001MF32	K142894	000
D805200001MF22	K142894	000
D805200001MCUSTOM2	K142894	000
D805200001M42	K142894	000
D805200001M32	K142894	000
D805200001M22	K142894	000
D805200001BCUSTOM2	K142894	000
D805200501M2210	K142894	000
D805200001MF10	K142894	000
D805200001MF42	K142894	000
D805200001MFCUSTOM2	K142894	000
D8052002JPS32	K142894	000
D8052002JPS22	K142894	000
D805200001SN2	K142894	000
D805200001SCUSTOM2	K142894	000
D805200001S42	K142894	000
D805200001S32	K142894	000
D805200001S22	K142894	000
D805200001MN2	K142894	000
D805200001MFN2	K142894	000
D805200501L210	K142894	000
D805200001L10	K142894	000
D805200301BN5	K142894	000
D805200001M10	K142894	000
D805200301BNX5	K142894	000
D805200301BNX10	K142894	000
D805200301BCUSTOM2	K142894	000
D805200301B4X5	K142894	000
D805200301B45	K142894	000
D805200301B3X5	K142894	000
D805200301B35	K142894	000
D805200301B25	K142894	000
D805200001S10	K142894	000
D805200301B10	K142894	000
D805200301BCUSTOMX5	K142894	000
D805200301BCUSTOMX10	K142894	000
D805200301BCUSTOM5	K142894	000
D805200301B4X10	K142894	000
D805200301B3X10	K142894	000
D805200301B2X5	K142894	000
D805200301B2X10	K142894	000
D805200301B1X5	K142894	000
D805200301B15	K142894	000
D805200301B1X10	K142894	000
D8052002JPSCUSTOM2	K142894	000
D8052005JPLN2	K142894	000
D805200501M2242	K142894	000
D805200501M2232	K142894	000
D805200501M2222	K142894	000
D805200501LT25N2	K142894	000
D805200501LT25CUSTOM2	K142894	000
D805200501LT2542	K142894	000
D805200501LT2532	K142894	000
D805200501LT2522	K142894	000
D805200501LNZ25N2	K142894	000
D805200501M22CUSTOM2	K142894	000
D805200501M22N2	K142894	000
D8052005JPLCUSTOM2	K142894	000
D8052005JPL42	K142894	000
D8052005JPL32	K142894	000
D8052005JPL22	K142894	000
D805200501MT25N2	K142894	000
D805200501MT25CUSTOM2	K142894	000
D805200501MT2542	K142894	000
D805200501MT2532	K142894	000
D805200501MT2522	K142894	000
D805200501LNZ25CUSTOM2	K142894	000
D805200501LNZ2542	K142894	000
D805200501LNZ2532	K142894	000
D805200501L22CUSTOM2	K142894	000
D805200501L2242	K142894	000
D805200501L2232	K142894	000
D805200501L222	K142894	000
D805200501L22	K142894	000
D805200301BN2	K142894	000
D805200301B42	K142894	000
D805200301B32	K142894	000
D805200301B22	K142894	000
D805200501L22N2	K142894	000
D805200501L32	K142894	000
D805200501LNZ2522	K142894	000
D805200501LN2	K142894	000
D805200501LFN2	K142894	000
D805200501LFCUSTOM2	K142894	000
D805200501LF42	K142894	000
D805200501LF32	K142894	000
D805200501LF22	K142894	000
D805200501LCUSTOM2	K142894	000
D805200501L42	K142894	000
D8052002JPSN2	K142894	000