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FDA 510(k)

VENUS DIAMOND FLOW

K-Number: K091635 · 2009-09-03

ApplicantHeraeus Kulzer, LLC
Decision Date2009-09-03
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VENUS DIAMOND FLOW is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, LLC. It received FDA 510(k) clearance on 2009-09-03 under 510(k) number K091635. 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 VENUS DIAMOND FLOW?

VENUS DIAMOND FLOW is a medical device that received FDA 510(k) clearance on 2009-09-03. The listed applicant is Heraeus Kulzer, LLC. The 510(k) number is K091635.

When did VENUS DIAMOND FLOW receive FDA 510(k) clearance?

VENUS DIAMOND FLOW received FDA 510(k) clearance on 2009-09-03, under 510(k) number K091635.

Who is the listed applicant for VENUS DIAMOND FLOW?

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

What is the FDA product code for VENUS DIAMOND FLOW?

The FDA product code for VENUS DIAMOND FLOW is EBF.

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Other records listing Heraeus Kulzer, LLC 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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