FDA.reportPublic FDA data

Karadent by TCS

Primary DI
D805200301B25
Brand
Karadent by TCS
Company
THERMOPLASTIC COMFORT SYS
Model
2003-01B/2-.5
Catalog number
2003-01B/2-.5
Device description
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.
Published
2024-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142894000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142894000TCS BlendThermoplastic Comfort Systems, Inc.2015-02-03EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D805200301B25PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, thermoplasticA thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
808897776
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D805500301BCUSTOMX100iFlex by TCS5003-01B/CustomX105003-01B/CustomX102025-01-22
D805500301BCUSTOMX10iFlex by TCS5003-01B/CustomX105003-01B/CustomX102024-03-11
D805200301B1X10Karadent by TCS2003-01B/1X102003-01B/1X102024-03-11
D805200301B35Karadent by TCS2003-01B/3-.52003-01B/3-.52024-03-11
D805200301B3X5Karadent by TCS2003-01B/3X52003-01B/3X52024-03-11
D805200301B45Karadent by TCS2003-01B/4-.52003-01B/4-.52024-03-11
D805200301B4X5Karadent by TCS2003-01B/4X52003-01B/4X52024-03-11
D805200301BCUSTOM2Karadent by TCS2003-01/B Custom2003-01/B Custom2024-03-11
D805200301BNX10Karadent by TCS2003-01B/NX102003-01B/NX102024-03-11
D805200301BNX5Karadent by TCS2003-01B/NX52003-01B/NX52024-03-11
D805500301B1X10iFlex by TCS5003-01B/1X105003-01B/1X102024-03-11
D805500301B3X5iFlex by TCS5003-01B/3X55003-01B/3X52024-03-11
D805200001M12Karadent by TCS2000-01/M12000-01/M12023-11-06
D805200001S12Karadent by TCS2000-01/S12000-01/S12023-11-06
D805200301B12Karadent by TCS2003-01/B12003-01/B12023-11-06
D805200501L12Karadent by TCS2005-01/L12005-01/L12023-11-06
D805200501L2212Karadent by TCS2005-01/L22-12005-01/L22-12023-11-06
D805200501LF12Karadent by TCS2000-01/MF12000-01/MF12023-11-06
D805200501M2212Karadent by TCS2005-01/M22-12005-01/M22-12023-11-06
D805200001M10Karadent by TCS2000-01/M12000-01/M12023-11-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07615208482775ProBase Hot / ProBase ColdIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-04-30
08056640078369major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-04-27
08056640078857major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-04-27
07701126631194Opti-Cryl Pour Acrylic Original X 22 lbPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEBI2026-04-23
EPRC66100851dima Print Denture Base 2pro3dure medical GmbHEBI2025-07-31
08435288443584IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443591IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443614IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443645IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443669IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443690IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443607IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443621IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443638IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443652IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443676IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443683IDODENTINEUNION DENTAL SAEBI2024-11-27
EPOLPMMP10090Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10100Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10110Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10120Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10130Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10140Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10150Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10160Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10170Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10180Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10190Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10200Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10210Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17