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FDA 510(k)

DEN-MAT DENTIN LINK

K-Number: K862449 · 1986-07-22

ApplicantDen-Mat Corp.
Decision Date1986-07-22
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DEN-MAT DENTIN LINK is the device name listed in this FDA 510(k) record. The listed applicant is Den-Mat Corp.. It received FDA 510(k) clearance on 1986-07-22 under 510(k) number K862449. 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 DEN-MAT DENTIN LINK?

DEN-MAT DENTIN LINK is a medical device that received FDA 510(k) clearance on 1986-07-22. The listed applicant is Den-Mat Corp.. The 510(k) number is K862449.

When did DEN-MAT DENTIN LINK receive FDA 510(k) clearance?

DEN-MAT DENTIN LINK received FDA 510(k) clearance on 1986-07-22, under 510(k) number K862449.

Who is the listed applicant for DEN-MAT DENTIN LINK?

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

What is the FDA product code for DEN-MAT DENTIN LINK?

The FDA product code for DEN-MAT DENTIN LINK 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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Other records listing Den-Mat Corp. 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.

K9831061ST IMPRESSIONK895731DEN-MAT CERINATE PORCELAINK895269DEN-MAT LAMI-QUICKK881918LIGHT-CURED ZIONOMER CEMENTK875351DEN-MAT PORETCH (PORCELAIN ETCHANT)K872510DEN-MAT TENURE

View all 29 devices →

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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