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K Number
K090391
Device Name
PULPDENT MICRO-HYBRID COMPOSITE
Manufacturer
PULPDENT CORPORATION
Date Cleared
2009-05-11

(83 days)

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

Pulpdent Micro-Hybrid Composite is a radiopaque, light-cured, fine-particle hybrid dental composite used for esthetic, direct resin restorations including all cavity classifications (1-V),) anterior and posterior restorations, Class V restorations and direct veneering.

Device Description

Pulpdent Micro-Hybrid Composite is a radiopaque, light-cured, fine-particle hybrid dental composite for esthetic, direct resin restorations.

AI/ML Overview

The provided document is a 510(k) premarket notification for a dental composite material, not an AI/ML medical device. Therefore, it does not contain the information requested about acceptance criteria, study details for AI performance, sample sizes for test/training sets, expert adjudication, or MRMC studies.

The document focuses on demonstrating substantial equivalence of the Pulpdent Micro-Hybrid Composite to existing predicate devices based on design, composition, performance, intended use, safety, and effectiveness, as per 21 CFR Part 872.3690. The safety and effectiveness are supported by general usage over 20 years for similar materials.

§ 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.