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K Number
K022973
Device Name
ADHESIVE 14
Manufacturer
AB ARDENT
Date Cleared
2002-11-22

(77 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

ADHESIVE 14 is to be used as a bonding agent for light curing composites and compomers to dentine tooth structure.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a dental bonding agent, Adhesive 14. It does not contain any information regarding acceptance criteria or a study demonstrating the device meets those criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device and regulatory compliance requirements. It does not include:

  • A table of acceptance criteria or reported device performance.
  • Details about sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
  • Information about MRMC studies, standalone algorithm performance, or ground truth types.
  • Details about training set size or how its ground truth was established.

Therefore, I cannot fulfill the request using the provided text.

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.