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FDA 510(k)

DENTAL COMPOSITE RESTORATIVE

K-Number: K863092 · 1986-09-19

ApplicantDentsply Intl.
Decision Date1986-09-19
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL COMPOSITE 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 1986-09-19 under 510(k) number K863092. 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 DENTAL COMPOSITE RESTORATIVE?

DENTAL COMPOSITE RESTORATIVE is a medical device that received FDA 510(k) clearance on 1986-09-19. The listed applicant is Dentsply Intl.. The 510(k) number is K863092.

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

DENTAL COMPOSITE RESTORATIVE received FDA 510(k) clearance on 1986-09-19, under 510(k) number K863092.

Who is the listed applicant for DENTAL COMPOSITE 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 DENTAL COMPOSITE RESTORATIVE?

The FDA product code for DENTAL COMPOSITE RESTORATIVE is EBF.

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Other records listing Dentsply Intl. 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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