Karadent by TCS 2003-01B/4X10

GUDID D805200301B4X10

Karadent 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 IDD805200301B4X10
NIH Device Record Key807a2b7d-311e-4afd-838c-bd48c68d19d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameKaradent by TCS
Version Model Number2003-01B/4X10
Catalog Number2003-01B/4X10
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
HIBCCD805200301B4X10 [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 [Karadent by TCS]

D8052005JPLN2Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D8052005JPLCUSTOM2Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D8052005JPL42Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D8052005JPL32Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D8052005JPL22Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501MT25N2Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501MT25CUSTOM2Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501MT2542Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501MT2532Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501MT2522Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501M22N2Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501M22CUSTOM2Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501M2242Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501M2232Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501M2222Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501LT25N2Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501LT25CUSTOM2Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501LT2542Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501LT2532Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501LT2522Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501LNZ25N2Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501LNZ25CUSTOM2Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501LNZ2542Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501LNZ2532Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501LNZ2522Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501LN2Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501LFN2Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501LFCUSTOM2Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501LF42Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501LF32Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501LF22Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501LCUSTOM2Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501L42Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501L32Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501L22N2Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501L22CUSTOM2Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501L2242Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501L2232Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501L222Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200501L22Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200301BN2Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200301B42Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200301B32Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200301B22Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D8052002JPSN2Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D8052002JPSCUSTOM2Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D8052002JPS42Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D8052002JPS32Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D8052002JPS22Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
D805200001SN2Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla

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