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K Number
K032042
Device Name
ENVISION
Manufacturer
SYBRON DENTAL SPECIALTIES, INC.
Date Cleared
2003-09-29

(90 days)

Product Code
DYH
Regulation Number
872.3750
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

EnVision is a light-cured orthodontic bonding adhesive that is designed to be used for the attachment of orthodontic appliances to teeth.

Device Description

The device is a chromatic orthodontic bonding adhesive. This single paste bonding adhesive initially has a blue color that enhances ease of use. Upon curing, the final color takes on the shade of the tooth, rendering it unnoticeable. Envision has an extended working time and has a very fast light cure property that achieves high strength, allowing active archwires to be placed immediately. EnVision is compatible with traditional etching and sealant procedures, as well as newer self-etching techniques

AI/ML Overview

The provided text is a 510(k) summary and FDA clearance letter for the EnVision orthodontic bonding adhesive. It focuses on regulatory approval based on substantial equivalence to existing devices, product description, and intended use.

Crucially, this document does not contain any information regarding acceptance criteria, performance data, or a clinical study that would describe how the device meets such criteria. It's a regulatory document, not a scientific study report.

Therefore, I cannot provide the requested information from this text. The questions below would be answered with "information not found in the provided document."

Here is a breakdown of why each point cannot be addressed:

  1. A table of acceptance criteria and the reported device performance: This document does not specify any performance criteria (e.g., bond strength, cure time, discoloration limits) nor does it report the device's performance against such criteria. The clearance is based on substantial equivalence to predicate devices, implying similar performance is expected, but no specific data is presented.
  2. Sample sized used for the test set and the data provenance: No test set is described, as no performance study is detailed.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment process for a test set is described.
  4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: No test set or adjudication method is described.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is an orthodontic bonding adhesive, not an AI-powered diagnostic tool. Therefore, an MRMC study involving human readers and AI is not applicable.
  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This device is a physical product (adhesive), not an algorithm. Standalone algorithm performance is not applicable.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is described as no performance study is detailed.
  8. The sample size for the training set: No training set is applicable as this is not a machine learning device.
  9. How the ground truth for the training set was established: Not applicable.

§ 872.3750 Bracket adhesive resin and tooth conditioner.

(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.