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FDA 510(k)

BONDING AGENT, PRESTIGE

K-Number: K760324 · 1976-08-03

ApplicantLee Pharmaceuticals
Decision Date1976-08-03
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BONDING AGENT, PRESTIGE is the device name listed in this FDA 510(k) record. The listed applicant is Lee Pharmaceuticals. It received FDA 510(k) clearance on 1976-08-03 under 510(k) number K760324. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONDING AGENT, PRESTIGE?

BONDING AGENT, PRESTIGE is a medical device that received FDA 510(k) clearance on 1976-08-03. The listed applicant is Lee Pharmaceuticals. The 510(k) number is K760324.

When did BONDING AGENT, PRESTIGE receive FDA 510(k) clearance?

BONDING AGENT, PRESTIGE received FDA 510(k) clearance on 1976-08-03, under 510(k) number K760324.

Who is the listed applicant for BONDING AGENT, PRESTIGE?

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 BONDING AGENT, PRESTIGE?

The FDA product code for BONDING AGENT, PRESTIGE is KLE.

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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: KLE)

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.

K262252MPa Max adhesiveDen-Mat Holdings, LLCK260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.

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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