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FDA 510(k)

CORE BUILD UP COMPOSITE

K-Number: K896950 · 1990-03-13

ApplicantConfi-Dental Products Co.
Decision Date1990-03-13
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CORE BUILD UP COMPOSITE is the device name listed in this FDA 510(k) record. The listed applicant is Confi-Dental Products Co.. It received FDA 510(k) clearance on 1990-03-13 under 510(k) number K896950. 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 CORE BUILD UP COMPOSITE?

CORE BUILD UP COMPOSITE is a medical device that received FDA 510(k) clearance on 1990-03-13. The listed applicant is Confi-Dental Products Co.. The 510(k) number is K896950.

When did CORE BUILD UP COMPOSITE receive FDA 510(k) clearance?

CORE BUILD UP COMPOSITE received FDA 510(k) clearance on 1990-03-13, under 510(k) number K896950.

Who is the listed applicant for CORE BUILD UP COMPOSITE?

The FDA 510(k) record lists Confi-Dental Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORE BUILD UP COMPOSITE?

The FDA product code for CORE BUILD UP COMPOSITE is EBF.

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Other records listing Confi-Dental Products Co. 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: 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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