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K Number
K972131
Device Name
BREATH ACE BREATHFRESHENER
Manufacturer
BEYOND 21ST CENTURY, INC.
Date Cleared
1997-07-18

(42 days)

Product Code
LCN
Regulation Number
872.6855
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

To remove food and debri from the mouth resulting in fresher breath.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding a device called "Breath Ace Breathfreshener." It does NOT contain information about acceptance criteria or a study proving that a device meets acceptance criteria.

The document states that the FDA has reviewed the 510(k) for the "Breath Ace Breathfreshener" and determined it to be substantially equivalent to devices marketed prior to May 28, 1976. This is a regulatory approval notice, not a study report.

Therefore, I cannot provide the requested information based on this document. The document primarily focuses on:

  • Substantial Equivalence: The FDA's determination that the Breath Ace Breathfreshener is substantially equivalent to a predicate device.
  • Regulatory Classification: The device is classified as "Unclassified."
  • Indications for Use: "To remove food and debris from the mouth resulting in fresher breath."
  • General Controls: The device is subject to general controls provisions of the Act (registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration).

There is no mention of performance metrics, clinical studies, sample sizes, expert opinions, ground truth, or MRMC studies for this device within the provided text.

§ 872.6855 Manual toothbrush.

(a)
Identification. A manual toothbrush is a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.(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. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.