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FDA 510(k)

Papacarie Duo

K-Number: K233768 · 2024-07-18

ApplicantElevate Oral Care
Decision Date2024-07-18
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Papacarie Duo is the device name listed in this FDA 510(k) record. The listed applicant is Elevate Oral Care. It received FDA 510(k) clearance on 2024-07-18 under 510(k) number K233768. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Papacarie Duo?

Papacarie Duo is a medical device that received FDA 510(k) clearance on 2024-07-18. The listed applicant is Elevate Oral Care. The 510(k) number is K233768.

When did Papacarie Duo receive FDA 510(k) clearance?

Papacarie Duo received FDA 510(k) clearance on 2024-07-18, under 510(k) number K233768.

Who is the listed applicant for Papacarie Duo?

The FDA 510(k) record lists Elevate Oral Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Papacarie Duo?

The FDA product code for Papacarie Duo is LBH.

Other records listing Elevate Oral Care as applicant

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.

K253778Allday Moisturizing RinseK222323Black Diamond

Related Devices (Code: LBH)

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.

K253052Fluoride Varnish (Type A,Type C)Nagy Oral Technology Qinhuangdao Co., Ltd.K252073VOCO Profluorid Varnish + BioMinVoco GmbHK261404UltraEZUltradent Products, Inc.K260830APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)Sangi Co., Ltd.K250714FluoroDose VarnishCentrix, Inc.K243777Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum)Theodent, LLC

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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