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K Number
K053060
Device Name
TCS UNBREAKABLE
Manufacturer
THERMOPLASTIC COMFORT SYSTEMS, INC.
Date Cleared
2006-07-20

(262 days)

Product Code
EBI
Regulation Number
872.3760
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

TCS® Unbreakable is a break resistant material used in the fabrication and repair of base plates for removeable dental prosthetic appliances where superior flexibility and patient comfort for the lifetime of the prosthetic are significant concerns. This includes, but not to be limited to, full and partial dentures, orthodontic devices, occlusal splints, and night guards.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) substantial equivalence letter from the FDA for a dental material (TCS® Unbreakable) and does not contain information about acceptance criteria or a study proving that a device meets such criteria.

Therefore, I cannot fulfill the request to provide:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set and data provenance.
  3. Number of experts used to establish ground truth and their qualifications.
  4. Adjudication method.
  5. MRMC comparative effectiveness study details.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Training set sample size.
  9. How ground truth for the training set was established.

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.