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
- 4000-01/M2 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
- 4000-01/M2 FDA UDI
- Primary DI / UDI-DI
- D805400001M22 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 by Thermoplastic Comfort Sys — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental appliance fabrication material, thermoplastic.
- Proform — Keystone Industries · U
- G-CAM — GRAPHENANO DENTAL SL. · Class II
- G-CAM — GRAPHENANO DENTAL SL. · Class II
- Vertex-Dental BV — Vertex-Dental B.V. · Class II
- FlexiNylon cartridges Natural — Perflex · Class II
- G-CAM — GRAPHENANO DENTAL SL. · Class II
- G-CAM — GRAPHENANO DENTAL SL. · Class II
- Clear Advantage — ORTHO TECHNOLOGY, INC. · Class I
Cleared under the same submission
K053060 also covers:
- Unbreakable by TCS — THERMOPLASTIC COMFORT SYS
- Unbreakable by TCS — THERMOPLASTIC COMFORT SYS
- Unbreakable by TCS — THERMOPLASTIC COMFORT SYS
- Unbreakable by TCS — THERMOPLASTIC COMFORT SYS
- Unbreakable by TCS — THERMOPLASTIC COMFORT SYS
- Unbreakable by TCS — THERMOPLASTIC COMFORT SYS
- Unbreakable by TCS — THERMOPLASTIC COMFORT SYS
- Unbreakable by TCS — THERMOPLASTIC COMFORT SYS
- Unbreakable by TCS — THERMOPLASTIC COMFORT SYS
- Unbreakable by TCS — THERMOPLASTIC COMFORT SYS
- Unbreakable by TCS — THERMOPLASTIC COMFORT SYS
- Unbreakable by TCS — THERMOPLASTIC COMFORT SYS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Thermoplastic Comfort Sys
Sources (1)
- FDA UDI 21b969c6-6c27-4c32-b732-ce9c2e8395ee 36 fields · synced May 30, 2026