Unbreakable by TCS 4003-01B/1X10

GUDID D805400301B1X10

Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base plates for removable dental prosthetic appliances. This includes but is not to be limited to full and partial removable dentures, orthodontics devices, occlusal splints, and night guards.

THERMOPLASTIC COMFORT SYS

Dental appliance fabrication material, thermoplastic
Primary Device IDD805400301B1X10
NIH Device Record Key4e3d6a5d-3dc5-43ea-9497-46ce542cfce7
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnbreakable by TCS
Version Model Number4003-01B/1X10
Catalog Number4003-01B/1X10
Company DUNS808897776
Company NameTHERMOPLASTIC COMFORT SYS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com
Phone562-426-2970
Emailinfo@tcsdentalinc.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD805400301B1X10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBIResin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-14
Device Publish Date2023-11-06

On-Brand Devices [Unbreakable by TCS]

D8054005JPLN2Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D8054005JPLCUSTOM2Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D8054005JPL42Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D8054005JPL32Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D8054005JPL22Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D8054005JPL12Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501MT25N2Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501MT25CUSTOM2Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501MT2542Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501MT2532Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501MT2522Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501MT2512Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501M22N2Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501M22CUSTOM2Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501M2242Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501M2232Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501M2222Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501M2212Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501LT25N2Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501LT25CUSTOM2Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501LT2542Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501LT2532Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501LT2522Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501LT2512Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501LNZ25N2Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501LNZ25CUSTOM2Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501LNZ2542Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501LNZ2532Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501LNZ2522Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501LNZ2512Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501LN2Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501LFN2Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501LFCUSTOM2Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501LF42Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501LF32Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501LF22Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501LF12Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501LCUSTOM2Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501L42Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501L32Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501L22N2Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501L22CUSTOM2Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501L2242Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501L2232Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501L2222Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501L2212Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501L22Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400501L12Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400301BN2Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base
D805400301BCUSTOM2Unbreakable by TCS is a break resistant material used in the fabrication and repair of the base

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