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FDA 510(k)

BREATHAID TONGUE SCRAPER

K-Number: K981808 · 1998-08-11

ApplicantBreathaid, LLC
Decision Date1998-08-11
Product CodeLCN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BREATHAID TONGUE SCRAPER is the device name listed in this FDA 510(k) record. The listed applicant is Breathaid, LLC. It received FDA 510(k) clearance on 1998-08-11 under 510(k) number K981808. The device is classified under product code LCN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREATHAID TONGUE SCRAPER?

BREATHAID TONGUE SCRAPER is a medical device that received FDA 510(k) clearance on 1998-08-11. The listed applicant is Breathaid, LLC. The 510(k) number is K981808.

When did BREATHAID TONGUE SCRAPER receive FDA 510(k) clearance?

BREATHAID TONGUE SCRAPER received FDA 510(k) clearance on 1998-08-11, under 510(k) number K981808.

Who is the listed applicant for BREATHAID TONGUE SCRAPER?

The FDA 510(k) record lists Breathaid, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BREATHAID TONGUE SCRAPER?

The FDA product code for BREATHAID TONGUE SCRAPER is LCN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LCN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K992270MIRACLEBREATH TONGUE CLEANERStellar Labs, Inc.K990344ORALGIENE TONGUE CLEANEROralgiene USA, Inc.K983683UNIK TONGUE CLEANERUnik Products, Inc.K983087BREATHTIQUE TONGUE SCRAPERCustom Medical Arts, Inc.K980842COPPER TONGUE SCRAPEROntel Products Corp.K980075CYBERSONICAmerican Dentronics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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