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FDA 510(k)

FORTIFY

K-Number: K882915 · 1988-08-12

ApplicantBisco, Inc.
Decision Date1988-08-12
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FORTIFY is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 1988-08-12 under 510(k) number K882915. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FORTIFY?

FORTIFY is a medical device that received FDA 510(k) clearance on 1988-08-12. The listed applicant is Bisco, Inc.. The 510(k) number is K882915.

When did FORTIFY receive FDA 510(k) clearance?

FORTIFY received FDA 510(k) clearance on 1988-08-12, under 510(k) number K882915.

Who is the listed applicant for FORTIFY?

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 FORTIFY?

The FDA product code for FORTIFY is EBF.

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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.

K250156Choice 2 DCK242816QuantiumK192007TheraBase, TheraBase CaK182917FluoroCalK180344TheraCal DCK171147REVEAL Bulk

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Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, Inc.

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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