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K Number
K210186
Device Name
PacBond One
Manufacturer
Pac-Dent, Inc.
Date Cleared
2021-07-16

(172 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

Direct Indications:

  1. light-cured composite and compomer restorations
  2. composite/ceramic/amalgam/metal repairs, cavity sealing for amalgam restorations
  3. light-cured or dual-cured core build-ups

Indirect Indications:

  1. veneers, porcelain, composite, and metal-based inlays, onlays, crowns, bridges
    endodontic posts
  2. cavity sealing as a pretreatment for indirect restoration
Device Description

Not Found

AI/ML Overview

The provided text is a U.S. FDA 510(k) clearance letter for a dental bonding agent called "PacBond One." It does not contain any information about acceptance criteria, device performance, clinical study details, or AI/software performance evaluations.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this document. The document primarily focuses on:

  • The FDA's determination of substantial equivalence for "PacBond One" to legally marketed predicate devices.
  • Regulatory requirements and guidelines applicable to the device.
  • Indications for Use for the device.

To answer your questions, I would need a document that describes the clinical or performance studies conducted for the PacBond One device, including details on its testing methodology and results.

§ 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.