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FDA 510(k)

ZENTIH FLOWABLE COMPOSITE (MULTIPLE)

K-Number: K970683 · 1997-07-15

ApplicantForemost Dental Mfg., Inc.
Decision Date1997-07-15
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZENTIH FLOWABLE COMPOSITE (MULTIPLE) 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 1997-07-15 under 510(k) number K970683. 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 ZENTIH FLOWABLE COMPOSITE (MULTIPLE)?

ZENTIH FLOWABLE COMPOSITE (MULTIPLE) is a medical device that received FDA 510(k) clearance on 1997-07-15. The listed applicant is Foremost Dental Mfg., Inc.. The 510(k) number is K970683.

When did ZENTIH FLOWABLE COMPOSITE (MULTIPLE) receive FDA 510(k) clearance?

ZENTIH FLOWABLE COMPOSITE (MULTIPLE) received FDA 510(k) clearance on 1997-07-15, under 510(k) number K970683.

Who is the listed applicant for ZENTIH FLOWABLE COMPOSITE (MULTIPLE)?

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 ZENTIH FLOWABLE COMPOSITE (MULTIPLE)?

The FDA product code for ZENTIH FLOWABLE COMPOSITE (MULTIPLE) is EBF.

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Other records listing Foremost Dental Mfg., 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.

K982201ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE)K981813PERMACEM AUTOMIX LUTING CEMENT SYSTEMK980963HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES)K970774TEMPOCEM NE (MULTIPLE)K970775TEMPO CEM (MULTIPLE)K954867IONOSIT SEAL

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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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