Karadent by TCS 2000-01/MF-Custom

GUDID D805200001MFCUSTOM2

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 ID: D805200001MFCUSTOM2
• NIH Device Record Key: 562df5e0-e1b9-472f-8df6-9bb00cd75846
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Karadent by TCS
• Version Model Number: 2000-01/MF-Custom
• Catalog Number: 2000-01/MF-Custom
• Company DUNS: 808897776
• Company Name: THERMOPLASTIC COMFORT SYS
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 562-426-2970
• Email: info@tcsdentalinc.com
• Phone: 562-426-2970
• Email: info@tcsdentalinc.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D805200001MFCUSTOM0 [Unit of Use]
HIBCC	D805200001MFCUSTOM2 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142894

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-01

On-Brand Devices [Karadent by TCS]

• D8052005JPLN2: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D8052005JPLCUSTOM2: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D8052005JPL42: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D8052005JPL32: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D8052005JPL22: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501MT25N2: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501MT25CUSTOM2: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501MT2542: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501MT2532: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501MT2522: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501M22N2: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501M22CUSTOM2: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501M2242: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501M2232: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501M2222: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501LT25N2: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501LT25CUSTOM2: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501LT2542: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501LT2532: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501LT2522: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501LNZ25N2: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501LNZ25CUSTOM2: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501LNZ2542: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501LNZ2532: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501LNZ2522: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501LN2: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501LFN2: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501LFCUSTOM2: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501LF42: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501LF32: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501LF22: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501LCUSTOM2: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501L42: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501L32: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501L22N2: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501L22CUSTOM2: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501L2242: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501L2232: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501L222: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200501L22: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200301BN2: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200301B42: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200301B32: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200301B22: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D8052002JPSN2: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D8052002JPSCUSTOM2: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D8052002JPS42: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D8052002JPS32: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D8052002JPS22: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla
• D805200001SN2: Karadent by TCS is a break resistant material used in the fabrication and repair of the base pla