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FDA 510(k)

REMBRANDT PORCELAIN TINTING KIT

K-Number: K864346 · 1987-01-07

ApplicantDen-Mat Corp.
Decision Date1987-01-07
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REMBRANDT PORCELAIN TINTING KIT 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 1987-01-07 under 510(k) number K864346. 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 REMBRANDT PORCELAIN TINTING KIT?

REMBRANDT PORCELAIN TINTING KIT is a medical device that received FDA 510(k) clearance on 1987-01-07. The listed applicant is Den-Mat Corp.. The 510(k) number is K864346.

When did REMBRANDT PORCELAIN TINTING KIT receive FDA 510(k) clearance?

REMBRANDT PORCELAIN TINTING KIT received FDA 510(k) clearance on 1987-01-07, under 510(k) number K864346.

Who is the listed applicant for REMBRANDT PORCELAIN TINTING KIT?

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 REMBRANDT PORCELAIN TINTING KIT?

The FDA product code for REMBRANDT PORCELAIN TINTING KIT is EBF.

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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

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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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