TCS UNBREAKABLE

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 Unbreakable.

Pre-market Notification Details

• Device ID: K053060
• 510k Number: K053060
• Device Name: TCS UNBREAKABLE
• Classification: Resin, Denture, Relining, Repairing, Rebasing
• Applicant: THERMOPLASTIC COMFORT SYSTEMS, INC. 2075 E. 27TH ST. Signal Hill, CA 90755
• Contact: Marilin Posca
• Correspondent: Marilin Posca; THERMOPLASTIC COMFORT SYSTEMS, INC. 2075 E. 27TH ST. 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: 2005-10-31
• Decision Date: 2006-07-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D805400501L2212	K053060	000
D8054002JPS32	K053060	000
D8054002JPS22	K053060	000
D8054002JPS12	K053060	000
D805400201SN2	K053060	000
D805400201SCUSTOM2	K053060	000
D805400201S42	K053060	000
D805400201S32	K053060	000
D805400201S22	K053060	000
D805400201S12	K053060	000
D8054002JPS42	K053060	000
D8054002JPSCUSTOM2	K053060	000
D805400501L22	K053060	000
D805400501L12	K053060	000
D805400301BN2	K053060	000
D805400301BCUSTOM2	K053060	000
D805400301B42	K053060	000
D805400301B32	K053060	000
D805400301B22	K053060	000
D805400301B12	K053060	000
D8054002JPSN2	K053060	000
D805400001MN2	K053060	000
D805400001MFN2	K053060	000
D805400001MFCUSTOM2	K053060	000
D805400301BCUSTOMX5	K053060	000
D805400301B4X5	K053060	000
D805400301B4X10	K053060	000
D805400301B45	K053060	000
D805400301B3X5	K053060	000
D805400301B35	K053060	000
D805400301B2X5	K053060	000
D805400301B2X10	K053060	000
D805400301B1X10	K053060	000
D805400301BNX5	K053060	000
D805400301BCUSTOM5	K053060	000
D805400001MF42	K053060	000
D805400001MF32	K053060	000
D805400001MF22	K053060	000
D805400001MF12	K053060	000
D805400001MCUSTOM2	K053060	000
D805400001M42	K053060	000
D805400001M32	K053060	000
D805400001M22	K053060	000
D805400001M12	K053060	000
D805400301B15	K053060	000
D8054005JPLN2	K053060	000
D805400501M22N2	K053060	000
D805400501M22CUSTOM2	K053060	000
D805400501M2242	K053060	000
D805400501M2232	K053060	000
D805400501M2222	K053060	000
D805400501M2212	K053060	000
D805400501LT25N2	K053060	000
D805400501LT25CUSTOM2	K053060	000
D805400501LT2542	K053060	000
D805400501MT2512	K053060	000
D805400501MT2522	K053060	000
D8054005JPLCUSTOM2	K053060	000
D8054005JPL42	K053060	000
D8054005JPL32	K053060	000
D8054005JPL22	K053060	000
D8054005JPL12	K053060	000
D805400501MT25N2	K053060	000
D805400501MT25CUSTOM2	K053060	000
D805400501MT2542	K053060	000
D805400501MT2532	K053060	000
D805400501LT2532	K053060	000
D805400501LT2522	K053060	000
D805400501LT2512	K053060	000
D805400501LF22	K053060	000
D805400501LF12	K053060	000
D805400501LCUSTOM2	K053060	000
D805400501L42	K053060	000
D805400501L32	K053060	000
D805400501L22N2	K053060	000
D805400501L22CUSTOM2	K053060	000
D805400501L2242	K053060	000
D805400501L2232	K053060	000
D805400501LF32	K053060	000
D805400501LF42	K053060	000
D805400501LNZ25N2	K053060	000
D805400501LNZ25CUSTOM2	K053060	000
D805400501LNZ2542	K053060	000
D805400501LNZ2532	K053060	000
D805400501LNZ2522	K053060	000
D805400501LNZ2512	K053060	000
D805400501LN2	K053060	000
D805400501LFN2	K053060	000
D805400501LFCUSTOM2	K053060	000
D805400501L2222	K053060	000