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K Number
K022492
Device Name
PULPDENT SEMI-GEL ETCH
Manufacturer
PULPDENT CORPORATION
Date Cleared
2002-10-11

(74 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

PULPDENT SEMI-GEL ETCH is a 35% phosphoric acid etchant in a viscous liquid form. It is used by the dental professional to etch dentin, enamel and glass ionomer cements.

Device Description

Pulpdent Semi-Gel Etch is a 35% phosphoric acid etchant in a viscous liquid form. It is used by the dental professional to etch dentin, enamel and glass ionomer cements.

AI/ML Overview

I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) premarket notification for a dental etchant (Pulpdent Semi-Gel Etch), and it focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets those criteria.

Here's why the requested information cannot be extracted:

  • Acceptance Criteria and Reported Device Performance (Table): The document states that "General usage of the predicate products over more than 10 years indicates a high benefit-to-risk ratio. There is no evidence of short-term or long-term risk or suspicion of any problems." This refers to predicate devices and not specific, quantitative acceptance criteria for Pulpdent Semi-Gel Etch itself, nor does it provide performance data for this specific device against such criteria.
  • Sample Size, Data Provenance, Ground Truth Experts, Adjudication Method, MRMC Study, Standalone Performance, Training Set Sample Size, Training Set Ground Truth: None of these details are present in the provided text. The submission relies on substantial equivalence to existing products rather than new clinical or performance studies with detailed methodologies.

The core of this 510(k) notification is to establish that Pulpdent Semi-Gel Etch is "substantially equivalent in design, composition and intended use" to previously approved predicate devices, not to present a new study with explicit acceptance criteria and corresponding performance data for the 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.