LogoFDA 510(k) Search
K Number
K162044
Device Name
Dentca Denture Base II
Manufacturer
DENTCA, Inc.
Date Cleared
2017-03-03

(221 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

DENTCA Denture Base II is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with Dentca Denture a computer-aided design and manufacturing (CAD/ CAM) system that includes the following components: digital denture base files based on a digital impression, stereolithographic additive printer, and curing light equipment.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA regarding a dental device, "Dentca Denture Base II." It confirms the device's substantial equivalence to legally marketed predicate devices and outlines general regulatory requirements.

However, the document DOES NOT contain information about:

  • Acceptance criteria for device performance.
  • Any study that proves the device meets specific acceptance criteria.
  • Sample sizes used for testing or training.
  • Information on data provenance (country, retrospective/prospective).
  • Number or qualifications of experts for ground truth establishment.
  • Adjudication methods.
  • Results of a multi-reader multi-case (MRMC) study.
  • Standalone (algorithm-only) performance.
  • Type of ground truth used.
  • How ground truth for a training set was established.

The document primarily focuses on regulatory approval based on substantial equivalence, rather than detailing the technical performance validation studies often associated with AI/ML-driven medical devices that would require such information.

Therefore, I cannot provide the requested information based on the given text.

§ 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.