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K Number
K962370
Device Name
PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE
Manufacturer
CHALLENGE PRODUCTS, INC.
Date Cleared
1997-03-31

(285 days)

Product Code
EJR
Regulation Number
872.6030
Type
Traditional
Panel
Dental
Reference & Predicate Devices
K940496
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The intended use of the prophy paste is to help remove materia alba, plaque and resistant stains from the teeth.

Device Description

The device is a prophy paste which is used by dental professionals to help remove resistant stains from the surface of the teeth.

AI/ML Overview

This document is a 510(k) summary for a prophy paste, which is a dental abrasive used for cleaning teeth. It does not present acceptance criteria or a study proving the device meets said criteria in the way typically found for medical devices that utilize algorithms or AI.

The information provided describes:

  • Device Name: Prophy paste
  • Manufacturer: Challenge Products, Inc.
  • Predicate Device: Challenge Products, Inc. Prophy Paste (K940496)
  • Device Description: A prophy paste used by dental professionals to help remove resistant stains.
  • Intended Use: To help remove materia alba, plaque, and resistant stains from teeth.
  • Technological Characteristics: Minor differences from the predicate, not impacting safety or effectiveness.
  • Safety Review: A review of 11 MDR records related to FDA product code "EJR" (prophy paste).

Therefore, I cannot provide the requested table or answer the questions related to acceptance criteria, algorithm performance, ground truth, or study methodology because this information is not present in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device, a different regulatory pathway than showing performance against pre-defined acceptance criteria through a study for a novel device or AI.

§ 872.6030 Oral cavity abrasive polishing agent.

(a)
Identification. An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.