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FDA 510(k)

DUAL CEMENT

K-Number: K901917 · 1990-06-28

ApplicantIvoclar North America, Inc.
Decision Date1990-06-28
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DUAL CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar North America, Inc.. It received FDA 510(k) clearance on 1990-06-28 under 510(k) number K901917. 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 DUAL CEMENT?

DUAL CEMENT is a medical device that received FDA 510(k) clearance on 1990-06-28. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K901917.

When did DUAL CEMENT receive FDA 510(k) clearance?

DUAL CEMENT received FDA 510(k) clearance on 1990-06-28, under 510(k) number K901917.

Who is the listed applicant for DUAL CEMENT?

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

What is the FDA product code for DUAL CEMENT?

The FDA product code for DUAL CEMENT is EBF.

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Other records listing Ivoclar North America, 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.

K012174ERIS LAYERING MATERIALSK011491HELIOSEAL CLEAR CHROMAK011492IN TEN-SK011490MODIFICATION TO EXCITEK011022BIOUNIVERSAL PDFK011023D.SIGN 96

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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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