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K Number
K981948
Device Name
APOLLO 95E
Manufacturer
DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC.
Date Cleared
1998-08-18

(76 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

The Apollo 95E produces visible light for the polymerization of dental materials and for tooth whitening.

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text from the FDA 510(k) letter for the Apollo 95E device does not contain the specific information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The document is a clearance letter indicating that the FDA has reviewed the device and determined it to be substantially equivalent to a legally marketed predicate device. It defines the "Indications For Use" for the Apollo 95E as producing visible light for the polymerization of dental materials and for tooth whitening.

However, it does not include:

  • A table of acceptance criteria or reported device performance.
  • Details about a study to prove the device meets acceptance criteria.
  • Sample sizes for test or training sets.
  • Information on expert qualifications or adjudication methods.
  • Whether MRMC or standalone performance studies were conducted.
  • The type of ground truth used.

This type of information would typically be found in the 510(k) submission itself, which is a much more extensive document that includes details of testing and performance data. The letter provided is merely the FDA's decision based on that submission.

§ 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.