BREATHAID TONGUE SCRAPER

• K Number: K981808
• Device Name: BREATHAID TONGUE SCRAPER
• Manufacturer: BREATHAID, LLC.
• Date Cleared: 1998-08-11 ( 82 days)
• Product Code: LCN
• Regulation Number: 872.6855
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, or study methodologies. The document is a 510(k) clearance letter from the FDA for a device called "BreathAid Tongue Scraper." It confirms that the device is substantially equivalent to a predicate device and can be marketed.

Therefore, I cannot fulfill your request for the detailed information on acceptance criteria and study design as it is not present in the given text.

Regulation Number and Section

§ 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.