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FDA 510(k)

COMPOSITE 168 RESTORATIVE SYSTEM

K-Number: K973221 · 1998-02-09

ApplicantDentsply Intl.
Decision Date1998-02-09
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COMPOSITE 168 RESTORATIVE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1998-02-09 under 510(k) number K973221. 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 COMPOSITE 168 RESTORATIVE SYSTEM?

COMPOSITE 168 RESTORATIVE SYSTEM is a medical device that received FDA 510(k) clearance on 1998-02-09. The listed applicant is Dentsply Intl.. The 510(k) number is K973221.

When did COMPOSITE 168 RESTORATIVE SYSTEM receive FDA 510(k) clearance?

COMPOSITE 168 RESTORATIVE SYSTEM received FDA 510(k) clearance on 1998-02-09, under 510(k) number K973221.

Who is the listed applicant for COMPOSITE 168 RESTORATIVE SYSTEM?

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 COMPOSITE 168 RESTORATIVE SYSTEM?

The FDA product code for COMPOSITE 168 RESTORATIVE SYSTEM 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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