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FDA 510(k)

PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT

K-Number: K912256 · 1991-07-24

ApplicantLee Pharmaceuticals
Decision Date1991-07-24
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT is the device name listed in this FDA 510(k) record. The listed applicant is Lee Pharmaceuticals. It received FDA 510(k) clearance on 1991-07-24 under 510(k) number K912256. 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 PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT?

PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT is a medical device that received FDA 510(k) clearance on 1991-07-24. The listed applicant is Lee Pharmaceuticals. The 510(k) number is K912256.

When did PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT receive FDA 510(k) clearance?

PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT received FDA 510(k) clearance on 1991-07-24, under 510(k) number K912256.

Who is the listed applicant for PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT?

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 PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT?

The FDA product code for PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT 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 4K900809LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETSK894315RESTOBOND 3/DENTIN-ENAMEL BONDING AGENTK881903PROSTHODENT 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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