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FDA 510(k)

SR-ISOSIT SPECTRA LINK SYSTEM

K-Number: K910069 · 1992-03-02

ApplicantIvoclar North America, Inc.
Decision Date1992-03-02
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SR-ISOSIT SPECTRA LINK SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar North America, Inc.. It received FDA 510(k) clearance on 1992-03-02 under 510(k) number K910069. 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 SR-ISOSIT SPECTRA LINK SYSTEM?

SR-ISOSIT SPECTRA LINK SYSTEM is a medical device that received FDA 510(k) clearance on 1992-03-02. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K910069.

When did SR-ISOSIT SPECTRA LINK SYSTEM receive FDA 510(k) clearance?

SR-ISOSIT SPECTRA LINK SYSTEM received FDA 510(k) clearance on 1992-03-02, under 510(k) number K910069.

Who is the listed applicant for SR-ISOSIT SPECTRA LINK SYSTEM?

The FDA 510(k) record lists Ivoclar North America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SR-ISOSIT SPECTRA LINK SYSTEM?

The FDA product code for SR-ISOSIT SPECTRA LINK SYSTEM is KLE.

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Other records listing Ivoclar North America, Inc. 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.

K012174ERIS LAYERING MATERIALSK011491HELIOSEAL CLEAR CHROMAK011492IN TEN-SK011490MODIFICATION TO EXCITEK011023D.SIGN 96K011022BIOUNIVERSAL PDF

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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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