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K Number
K042048
Device Name
GELATO PROPHYLAXIS PASTE
Manufacturer
DEEPAK PRODUCTS, INC.
Date Cleared
2004-10-26

(88 days)

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

For cleaning and polishing procedures as part of a professionally administered prophylaxis treatment. Pastes containing fluoride are not considered a replacement for other forms of fluoride therapy. Gelato dental prophylaxis paste is for professional use only and is designed for application during standard dental practice hygiene procedures. This product contains fluoride at a concentration of 1.23% fluoride ion.

Device Description

Gelato Prophylaxis Paste

AI/ML Overview

The provided text is a 510(k) cleared device letter from the FDA for "Gelato Prophylaxis Paste". This document is a clearance letter, not a study report, and therefore does not contain information about acceptance criteria, study design, or performance metrics of a device in the way a clinical trial or validation study would.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This means the FDA did not require new performance data or a clinical study proving the device met specific acceptance criteria. Instead, the clearance is based on its "substantial equivalence" to a predicate device already on the market.

Therefore, I cannot provide the requested information from the given text because it does not exist within these documents. There is no information on:

  1. A table of acceptance criteria and the reported device performance: Not applicable for a 510(k) substantial equivalence determination when new performance data isn't required.
  2. Sample size used for the test set and the data provenance: No test set information is provided.
  3. Number of experts used to establish the ground truth for the test set and the qualifications: No ground truth establishment is described.
  4. Adjudication method: Not described.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
  6. Standalone performance: Not applicable in this context.
  7. Type of ground truth used: Not applicable.
  8. Sample size for the training set: Not applicable (no algorithm training is mentioned).
  9. How the ground truth for the training set was established: Not applicable.

The document is a regulatory clearance based on substantial equivalence, not a report of a scientific study demonstrating specific performance metrics against pre-defined acceptance criteria.

§ 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.