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K Number
K091300
Device Name
ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079
Manufacturer
CAO GROUP, INC.
Date Cleared
2009-07-23

(80 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
K061322,K061906,K951582
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Ascent Prep Porcelain Primer is indicated for the conditioning of porcelain dental appliances prior to the placement or adhesion of said porcelain to tooth structures within the oral cavity, resin based tooth restorative materials, or to other porcelain oral appliances.

Device Description

The Ascent Prep Porcelain Primer is a clear, low viscosity liquid composition containing conditioners and demineralizers in a solvent carrier. The liquid is marketed in preloaded 3cc syringes, which are shrink-wrapped for safety and marked with batch information for manufacturing traceability.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental product, the Ascent Prep Porcelain Primer, seeking substantial equivalence to existing devices. The document does not describe a study involving acceptance criteria, device performance metrics, sample sizes for test or training sets, ground truth establishment by experts, or any kind of AI or multi-reader multi-case (MRMC) study.

The focus of the text is on establishing equivalency based on:

  • Device Name: Ascent Prep Porcelain Primer
  • Common Name: Porcelain conditioner
  • Product Classification: Agent, Tooth Bonding, Resin (21 CFR 872.3200, Product Code: KLE)
  • Legally Marketed Predicate Devices:
    • Porcelain Primer, Manufactured by J. Morita USA, Inc. (K061322)
    • Clearfil Ceramic Primer, Manufactured by Kuraray Medical, Inc. (K061906)
    • Ultradent Porcelain Etch, Manufactured by Ultradent Products, Inc. (K951582)
  • Rationale for Substantial Equivalence: Shares similarities for use with predicate devices (conditioning porcelain dental appliances for adhesion to teeth, resin, or other oral appliances), similar indications for use, and application methods.
  • Description of Submitted Device: Clear, low viscosity liquid with conditioners and demineralizers in a solvent carrier, marketed in preloaded 3cc syringes.
  • Intended Uses: Application on any porcelain appliance for placement in the oral cavity to create an adhesion interface between porcelain and resin-based adhesive materials.
  • Technological Characteristics: Similar substances, active constituents, concentrations, indications for use, and application methods to predicate devices.
  • Performance Standards: Refers to ISO 7405:1997 (Dentistry - Preclinical evaluation of biocompatibility of medical devices used in dentistry - Test methods for dental materials).

The document mentions "Part 7: Performance Data" twice, but the content of Part 7 is not included in the provided text. Therefore, I cannot extract information related to acceptance criteria or a study proving the device meets them.

The sections regarding acceptance criteria, study details, sample sizes, ground truth, expert involvement, adjudication, MRMC studies, standalone performance, and training sets cannot be filled from the provided text because the text does not contain this type of performance study information. It primarily focuses on the regulatory submission for substantial equivalence based on product characteristics and intended use compared to existing devices.

§ 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.