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K Number
K222581
Device Name
Stela Automix System
Manufacturer
SDI Limited
Date Cleared
2022-10-28

(63 days)

Product Code
EBF,KLE
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
K053040,K150218,K110302,K083610
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Stela Primer:

  • Dentin and enamel bonding

Stela Automix:

  • Direct Class I, II, III and V cavities. Ideally Class I and II.
  • Base or liner
  • Core build-ups.
Device Description

The Stela Automix System is an easy to use bulk-fill radiopaque self-cure dental restorative system for dental professional use. The system comprises:

  • Stela Automix a double-barrel syringe containing two pastes which are mixed and dispensed with a single-use mixing tip and
  • Stela Primer - an adhesive liquid packaged in a bottle. A bendable disposable brush applicator is used to apply Stela Primer.
    The combination of Stela Primer and Stela Automix will bond to both enamel and dentin without scrubbing or light curing.
AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental device (Stela Automix System). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving the device meets specific performance acceptance criteria for an AI/ML medical device or a new type of device.

Therefore, the document does not contain the information needed to answer your request about acceptance criteria, study design for AI/ML performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies.

The document primarily discusses:

  • Biocompatibility testing: To ensure the device materials are safe for biological contact.
  • Non-clinical performance data (bench testing): To compare the physical and chemical properties of the Stela Automix System to predicate devices and ensure it meets relevant ISO standards (e.g., working time, setting time, flexural strength, shade, color stability, radio-opacity, shear bond strength).

No information regarding AI/ML device performance, human-in-the-loop studies, or the statistical details usually associated with such studies (like sample size for test sets, number of experts for ground truth, adjudication methods, or training set details) is present because this is not an AI/ML device.

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.