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K Number
K071278
Device Name
EMBRACE DUAL CURE COMPOSITE MATERIALS
Manufacturer
PULPDENT CORPORATION
Date Cleared
2007-06-29

(53 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

Embrace™ Dual Cure Composite Materials are multi-purpose, hydrophilic, fluoride-releasing, resin-based materials that contain no Bisphenol A and bond tightly to dentition.

Embrace™ Dual Cure Composite Materials are used to permanently cement dental posts, porcelain crowns, inlays, onlays, bridges, porcelain/laminate veneers and periodontal splints, to repair porcelain crowns intra-orally and as a build-up and repair material.

Device Description

Embrace™ Dual Cure Composite Materials are multi-purpose, hydrophilic, fluoride-releasing, resin-based materials that contain no Bisphenol A and bond tightly to dentition.

AI/ML Overview

The provided text is a 510(k) premarket notification for a dental material (PULPDENT EMBRACE™ DUAL CURE COMPOSITE MATERIALS). This type of submission focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than conducting a de novo study with acceptance criteria and performance data in the way an AI/ML device would.

Therefore, the document does not contain the information requested in your numbered list, such as:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes used for test sets, data provenance, or details on training sets.
  3. Number of experts, their qualifications, or adjudication methods for ground truth.
  4. Multi-reader multi-case comparative effectiveness studies.
  5. Standalone algorithm performance.
  6. Specific ground truth types.

Instead, the document states:

  • "PULPDENT DUAL CURE COMPOSITE MATERIALS are substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above."
  • It refers to predicate devices that have "been found substantially equivalent under the 510(k) Premarket Notification process as Class II Dental Devices."
  • It cites a general statement from an NIH Technology Assessment Conference regarding the high benefit-to-risk ratio and safety of dental restorative materials over time.

In summary, this document describes a regulatory pathway based on substantial equivalence to predicate devices for a dental material, not a de novo study with performance metrics as typically seen for AI/ML device evaluations.

§ 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.