iFlex by TCS 5003-01B/2X5

GUDID D805500301B2X5

iFlex 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 IDD805500301B2X5
NIH Device Record Keybbf69e57-e44f-4c6b-8313-38999b8df344
Commercial Distribution StatusIn Commercial Distribution
Brand NameiFlex by TCS
Version Model Number5003-01B/2X5
Catalog Number5003-01B/2X5
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
HIBCCD805500301B2X5 [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 [iFlex by TCS]

D8055005LPLCUSTOM2iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D8055005JPSN2iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D8055005JPSCUSTOM2iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D8055005JPS42iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D8055005JPS32iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D8055005JPS22iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D8055005JPS12iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D8055005JPLN2iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D8055005JPL42iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D8055005JPL32iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D8055005JPL22iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D8055005JPL12iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501MT25N2iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501MT25CUSTOM2iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501MT2542iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501MT2532iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501MT2522iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501MT2512iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501M22N2iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501M22CUSTOM2iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501M2242iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501M2232iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501M2222iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501M2212iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501LT25N2iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501LT25CUSTOM2iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501LT2542iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501LT2532iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501LT2522iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501LT2512iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501LNZ25N2iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501LNZ25CUSTOM2iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501LNZ2542iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501LNZ2532iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501LNZ2522iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501LNZ2512iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501LN2iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501LFN2iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501LFCUSTOM2iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501LF32iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501LF22iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501LF12iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501LCUSTOM2iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501L42iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501L32iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501L22N2iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501L22CUSTOM2iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501L2242iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501L2232iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates
D805500501L2222iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates

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