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FDA 510(k)

LION SE ONE STEP ORTHODONTIC ADHESIVE

K-Number: K080445 · 2008-07-16

ApplicantClassone Orthodontics, Inc.
Decision Date2008-07-16
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LION SE ONE STEP ORTHODONTIC ADHESIVE is the device name listed in this FDA 510(k) record. The listed applicant is Classone Orthodontics, Inc.. It received FDA 510(k) clearance on 2008-07-16 under 510(k) number K080445. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LION SE ONE STEP ORTHODONTIC ADHESIVE?

LION SE ONE STEP ORTHODONTIC ADHESIVE is a medical device that received FDA 510(k) clearance on 2008-07-16. The listed applicant is Classone Orthodontics, Inc.. The 510(k) number is K080445.

When did LION SE ONE STEP ORTHODONTIC ADHESIVE receive FDA 510(k) clearance?

LION SE ONE STEP ORTHODONTIC ADHESIVE received FDA 510(k) clearance on 2008-07-16, under 510(k) number K080445.

Who is the listed applicant for LION SE ONE STEP ORTHODONTIC ADHESIVE?

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

What is the FDA product code for LION SE ONE STEP ORTHODONTIC ADHESIVE?

The FDA product code for LION SE ONE STEP ORTHODONTIC ADHESIVE is DYH.

Related Clinical Trials

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Other records listing Classone Orthodontics, Inc. 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.

K093059SELECT DEFENSE DENTAL PIT AND FISSURE SEALANTK053379RELI-ON ONE STEP, ORTHODONTIC ADHESIVE

Related Devices (Code: DYH)

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.

K261129OrthoFitSpident Co., Ltd.K261840BracePaste Prime PlusAmerican OrthodonticsK250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveOrmco CorporationK242537BracePaste Fluoride SealantAmerican Orthodontics Corp.K2340433M™ Transbond™ Orthodontic Adhesive3M Unitek Orthodontic ProductsK231817AlignerFlow LCVoco GmbH

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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