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FDA 510(k)

PERFIT DENTAL RESTORATIVE COMPOSITE

K-Number: K781580 · 1978-10-11

ApplicantLocite Corp.
Decision Date1978-10-11
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERFIT DENTAL RESTORATIVE COMPOSITE is the device name listed in this FDA 510(k) record. The listed applicant is Locite Corp.. It received FDA 510(k) clearance on 1978-10-11 under 510(k) number K781580. 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 PERFIT DENTAL RESTORATIVE COMPOSITE?

PERFIT DENTAL RESTORATIVE COMPOSITE is a medical device that received FDA 510(k) clearance on 1978-10-11. The listed applicant is Locite Corp.. The 510(k) number is K781580.

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

PERFIT DENTAL RESTORATIVE COMPOSITE received FDA 510(k) clearance on 1978-10-11, under 510(k) number K781580.

Who is the listed applicant for PERFIT DENTAL RESTORATIVE COMPOSITE?

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

What is the FDA product code for PERFIT DENTAL RESTORATIVE COMPOSITE?

The FDA product code for PERFIT DENTAL RESTORATIVE COMPOSITE is EBF.

Related Clinical Trials

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.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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