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FDA 510(k)

DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER)

K-Number: K860971 · 1986-03-25

ApplicantDen-Mat Corp.
Decision Date1986-03-25
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER) 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 1986-03-25 under 510(k) number K860971. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER)?

DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER) is a medical device that received FDA 510(k) clearance on 1986-03-25. The listed applicant is Den-Mat Corp.. The 510(k) number is K860971.

When did DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER) receive FDA 510(k) clearance?

DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER) received FDA 510(k) clearance on 1986-03-25, under 510(k) number K860971.

Who is the listed applicant for DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER)?

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 GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER)?

The FDA product code for DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER) is KLE.

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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: KLE)

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.

K262252MPa Max adhesiveDen-Mat Holdings, LLCK260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.

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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