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Unbreakable by TCS

FDA UDI

Class II (US FDA UDI)

by Thermoplastic Comfort Sys

Identity

Trade Name
Unbreakable by TCS FDA UDI
Generic Name
Dental appliance fabrication material, thermoplastic FDA UDI
Device Name
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 is not to be limited to full and partial removable dentures, orthodontics devices, occlusal splints, and night guards. FDA UDI
Model / Reference
4005-01/LT25-1 FDA UDI
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 is not to be limited to full and partial removable dentures, orthodontics devices, occlusal splints, and night guards. FDA UDI

Identifiers

Catalog Number
4005-01/LT25-1 FDA UDI
Primary DI / UDI-DI
D805400501LT2512 FDA UDI
510(k) Number
K053060 FDA UDI
FDA Product Code
EBI FDA UDI
GMDN Term
Dental appliance fabrication material, thermoplastic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3760 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental appliance fabrication material, thermoplastic

Unbreakable by TCS is a cutting-edge, break-resistant dental material designed for the fabrication and repair of removable dentures, orthodontics devices, occlusal splints, and night guards. With its proprietary thermoplastic composition, this device offers unparalleled durability and reliability in the mouth.

Similar devices

Also classified as Dental appliance fabrication material, thermoplastic.

Cleared under the same submission

K053060 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Thermoplastic Comfort Sys

Sources (1)

  • FDA UDI 46aaf0e6-2299-4acc-b30b-3a7302fd2526 36 fields · synced Jul 18, 2026