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FDA 510(k)

BISCO DUO LINK D/C LUTING COMPOSITE

K-Number: K934596 · 1994-01-26

ApplicantBisco, Inc.
Decision Date1994-01-26
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BISCO DUO LINK D/C LUTING COMPOSITE is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 1994-01-26 under 510(k) number K934596. 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 BISCO DUO LINK D/C LUTING COMPOSITE?

BISCO DUO LINK D/C LUTING COMPOSITE is a medical device that received FDA 510(k) clearance on 1994-01-26. The listed applicant is Bisco, Inc.. The 510(k) number is K934596.

When did BISCO DUO LINK D/C LUTING COMPOSITE receive FDA 510(k) clearance?

BISCO DUO LINK D/C LUTING COMPOSITE received FDA 510(k) clearance on 1994-01-26, under 510(k) number K934596.

Who is the listed applicant for BISCO DUO LINK D/C LUTING COMPOSITE?

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

What is the FDA product code for BISCO DUO LINK D/C LUTING COMPOSITE?

The FDA product code for BISCO DUO LINK D/C LUTING COMPOSITE is KLE.

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Other records listing Bisco, 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.

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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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