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FDA 510(k)

RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT

K-Number: K894315 · 1989-10-31

ApplicantLee Pharmaceuticals
Decision Date1989-10-31
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT is the device name listed in this FDA 510(k) record. The listed applicant is Lee Pharmaceuticals. It received FDA 510(k) clearance on 1989-10-31 under 510(k) number K894315. 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 RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT?

RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT is a medical device that received FDA 510(k) clearance on 1989-10-31. The listed applicant is Lee Pharmaceuticals. The 510(k) number is K894315.

When did RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT receive FDA 510(k) clearance?

RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT received FDA 510(k) clearance on 1989-10-31, under 510(k) number K894315.

Who is the listed applicant for RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT?

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 RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT?

The FDA product code for RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT 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 BRACKETSK881903PROSTHODENT VLK873123LEE COMPOSITE INLAY SYSTEMK863157RESTODENT POSTERIOR

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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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