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FDA 510(k)

COPPER TONGUE SCRAPER

K-Number: K980842 · 1998-05-20

ApplicantOntel Products Corp.
Decision Date1998-05-20
Product CodeLCN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COPPER TONGUE SCRAPER is the device name listed in this FDA 510(k) record. The listed applicant is Ontel Products Corp.. It received FDA 510(k) clearance on 1998-05-20 under 510(k) number K980842. 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 COPPER TONGUE SCRAPER?

COPPER TONGUE SCRAPER is a medical device that received FDA 510(k) clearance on 1998-05-20. The listed applicant is Ontel Products Corp.. The 510(k) number is K980842.

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

COPPER TONGUE SCRAPER received FDA 510(k) clearance on 1998-05-20, under 510(k) number K980842.

Who is the listed applicant for COPPER TONGUE SCRAPER?

The FDA 510(k) record lists Ontel Products Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COPPER TONGUE SCRAPER?

The FDA product code for COPPER TONGUE SCRAPER is LCN.

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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.K981808BREATHAID TONGUE SCRAPERBreathaid, LLCK980075CYBERSONICAmerican 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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