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FDA 510(k)

DYTRACT FLOW RESTORATIVE

K-Number: K982395 · 1998-08-18

ApplicantDentsply Intl.
Decision Date1998-08-18
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DYTRACT FLOW RESTORATIVE is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1998-08-18 under 510(k) number K982395. 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 DYTRACT FLOW RESTORATIVE?

DYTRACT FLOW RESTORATIVE is a medical device that received FDA 510(k) clearance on 1998-08-18. The listed applicant is Dentsply Intl.. The 510(k) number is K982395.

When did DYTRACT FLOW RESTORATIVE receive FDA 510(k) clearance?

DYTRACT FLOW RESTORATIVE received FDA 510(k) clearance on 1998-08-18, under 510(k) number K982395.

Who is the listed applicant for DYTRACT FLOW RESTORATIVE?

The FDA 510(k) record lists Dentsply Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYTRACT FLOW RESTORATIVE?

The FDA product code for DYTRACT FLOW RESTORATIVE is EBF.

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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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