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FDA 510(k)

BISFIL-M(LIGHT CURABLE ANTERIOR COMPOSITE)

K-Number: K853001 · 1985-08-16

ApplicantBisco, Inc.
Decision Date1985-08-16
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BISFIL-M(LIGHT CURABLE ANTERIOR 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 1985-08-16 under 510(k) number K853001. 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 BISFIL-M(LIGHT CURABLE ANTERIOR COMPOSITE)?

BISFIL-M(LIGHT CURABLE ANTERIOR COMPOSITE) is a medical device that received FDA 510(k) clearance on 1985-08-16. The listed applicant is Bisco, Inc.. The 510(k) number is K853001.

When did BISFIL-M(LIGHT CURABLE ANTERIOR COMPOSITE) receive FDA 510(k) clearance?

BISFIL-M(LIGHT CURABLE ANTERIOR COMPOSITE) received FDA 510(k) clearance on 1985-08-16, under 510(k) number K853001.

Who is the listed applicant for BISFIL-M(LIGHT CURABLE ANTERIOR 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 BISFIL-M(LIGHT CURABLE ANTERIOR COMPOSITE)?

The FDA product code for BISFIL-M(LIGHT CURABLE ANTERIOR COMPOSITE) is EBF.

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Other records listing Bisco, Inc. as applicant

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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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