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FDA 510(k)

DENFIL

K-Number: K042124 · 2004-08-13

ApplicantVericom Co., Ltd.
Decision Date2004-08-13
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENFIL is the device name listed in this FDA 510(k) record. The listed applicant is Vericom Co., Ltd.. It received FDA 510(k) clearance on 2004-08-13 under 510(k) number K042124. 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 DENFIL?

DENFIL is a medical device that received FDA 510(k) clearance on 2004-08-13. The listed applicant is Vericom Co., Ltd.. The 510(k) number is K042124.

When did DENFIL receive FDA 510(k) clearance?

DENFIL received FDA 510(k) clearance on 2004-08-13, under 510(k) number K042124.

Who is the listed applicant for DENFIL?

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

What is the FDA product code for DENFIL?

The FDA product code for DENFIL is EBF.

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Other records listing Vericom Co., Ltd. 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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