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FDA 510(k)

PERMACEM AUTOMIX LUTING CEMENT SYSTEM

K-Number: K981813 · 1998-07-10

ApplicantForemost Dental Mfg., Inc.
Decision Date1998-07-10
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERMACEM AUTOMIX LUTING CEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Foremost Dental Mfg., Inc.. It received FDA 510(k) clearance on 1998-07-10 under 510(k) number K981813. 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 PERMACEM AUTOMIX LUTING CEMENT SYSTEM?

PERMACEM AUTOMIX LUTING CEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1998-07-10. The listed applicant is Foremost Dental Mfg., Inc.. The 510(k) number is K981813.

When did PERMACEM AUTOMIX LUTING CEMENT SYSTEM receive FDA 510(k) clearance?

PERMACEM AUTOMIX LUTING CEMENT SYSTEM received FDA 510(k) clearance on 1998-07-10, under 510(k) number K981813.

Who is the listed applicant for PERMACEM AUTOMIX LUTING CEMENT SYSTEM?

The FDA 510(k) record lists Foremost Dental Mfg., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERMACEM AUTOMIX LUTING CEMENT SYSTEM?

The FDA product code for PERMACEM AUTOMIX LUTING CEMENT SYSTEM is EBF.

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Other records listing Foremost Dental Mfg., Inc. as applicant

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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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