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FDA 510(k)

AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE

K-Number: K040548 · 2004-03-19

ApplicantHarry J. Bosworth Co.
Decision Date2004-03-19
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE is the device name listed in this FDA 510(k) record. The listed applicant is Harry J. Bosworth Co.. It received FDA 510(k) clearance on 2004-03-19 under 510(k) number K040548. 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 AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE?

AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE is a medical device that received FDA 510(k) clearance on 2004-03-19. The listed applicant is Harry J. Bosworth Co.. The 510(k) number is K040548.

When did AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE receive FDA 510(k) clearance?

AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE received FDA 510(k) clearance on 2004-03-19, under 510(k) number K040548.

Who is the listed applicant for AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE?

The FDA 510(k) record lists Harry J. Bosworth Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE?

The FDA product code for AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE is DYH.

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Other records listing Harry J. Bosworth Co. 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.

K103585BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACPK100731BOSWORTH AIR POLISHERK061611BOSWORTH DENTIN RESINK051224BOSWORTH SEALK043170BOSWORTH BONDK040547AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE

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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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