FDA.reportPublic FDA data

Unbreakable by TCS

Primary DI
D8054000D9825N1
Brand
Unbreakable by TCS
Company
THERMOPLASTIC COMFORT SYS
Model
4000/D98x25-N
Catalog number
4000/D98x25-N
Device description
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 it not limited to full and partial removable dentures, orthodontic devices, occlusal splints and nightguards.
Published
2023-01-21
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
K053060000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053060000TCS UNBREAKABLEThermoplastic Comfort Systems, Inc.2006-07-20EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8054000D9825N1PrimaryHIBCC0

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.

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
D805200301B25Karadent by TCS2003-01B/2-.52003-01B/2-.52024-03-11
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

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