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FDA 510(k)

INSTA-BOND

K-Number: K810517 · 1981-03-24

ApplicantLee Pharmaceuticals
Decision Date1981-03-24
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INSTA-BOND is the device name listed in this FDA 510(k) record. The listed applicant is Lee Pharmaceuticals. It received FDA 510(k) clearance on 1981-03-24 under 510(k) number K810517. 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 INSTA-BOND?

INSTA-BOND is a medical device that received FDA 510(k) clearance on 1981-03-24. The listed applicant is Lee Pharmaceuticals. The 510(k) number is K810517.

When did INSTA-BOND receive FDA 510(k) clearance?

INSTA-BOND received FDA 510(k) clearance on 1981-03-24, under 510(k) number K810517.

Who is the listed applicant for INSTA-BOND?

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

What is the FDA product code for INSTA-BOND?

The FDA product code for INSTA-BOND is DYH.

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Other records listing Lee Pharmaceuticals 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.

K924378RESTOBOND 4K912256PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERTK900809LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETSK894315RESTOBOND 3/DENTIN-ENAMEL BONDING AGENTK881903PROSTHODENT VLK873123LEE COMPOSITE INLAY SYSTEM

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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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