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FDA 510(k)

ORTHODONTIC BONDING ADHESIVE CONTROL

K-Number: K904090 · 1991-04-29

ApplicantLancer Orthodontics, Inc.
Decision Date1991-04-29
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHODONTIC BONDING ADHESIVE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Lancer Orthodontics, Inc.. It received FDA 510(k) clearance on 1991-04-29 under 510(k) number K904090. 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 ORTHODONTIC BONDING ADHESIVE CONTROL?

ORTHODONTIC BONDING ADHESIVE CONTROL is a medical device that received FDA 510(k) clearance on 1991-04-29. The listed applicant is Lancer Orthodontics, Inc.. The 510(k) number is K904090.

When did ORTHODONTIC BONDING ADHESIVE CONTROL receive FDA 510(k) clearance?

ORTHODONTIC BONDING ADHESIVE CONTROL received FDA 510(k) clearance on 1991-04-29, under 510(k) number K904090.

Who is the listed applicant for ORTHODONTIC BONDING ADHESIVE CONTROL?

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

What is the FDA product code for ORTHODONTIC BONDING ADHESIVE CONTROL?

The FDA product code for ORTHODONTIC BONDING ADHESIVE CONTROL is DYH.

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Other records listing Lancer Orthodontics, Inc. as applicant

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K122069STORM MINI SCREWK071192BLUGOO HDK051552O.A.S.I. SYSTEMK991481PARAGONK904092LANCER ORIGINAL, SIERRA, GENERAL PURPOSEK904093BUCCAL TUBE, BUCCAL ATTACHMENT

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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

View on FDA Database →

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

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