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FDA 510(k)

DURAFILL MICROFILL RESTORATIVE MATERIAL

K-Number: K811669 · 1981-07-01

ApplicantKulzer, Inc.
Decision Date1981-07-01
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DURAFILL MICROFILL RESTORATIVE MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Kulzer, Inc.. It received FDA 510(k) clearance on 1981-07-01 under 510(k) number K811669. 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 DURAFILL MICROFILL RESTORATIVE MATERIAL?

DURAFILL MICROFILL RESTORATIVE MATERIAL is a medical device that received FDA 510(k) clearance on 1981-07-01. The listed applicant is Kulzer, Inc.. The 510(k) number is K811669.

When did DURAFILL MICROFILL RESTORATIVE MATERIAL receive FDA 510(k) clearance?

DURAFILL MICROFILL RESTORATIVE MATERIAL received FDA 510(k) clearance on 1981-07-01, under 510(k) number K811669.

Who is the listed applicant for DURAFILL MICROFILL RESTORATIVE MATERIAL?

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

What is the FDA product code for DURAFILL MICROFILL RESTORATIVE MATERIAL?

The FDA product code for DURAFILL MICROFILL RESTORATIVE MATERIAL is EBF.

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Other records listing Kulzer, Inc. as applicant

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.

K905058PALAVIT LK904928PALAVIT GLCK910263CHARISMAK910719SILICOATER MDK905131DURAFILL COLOR VSK905302DENTHESIVE

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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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