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FDA 510(k)

TEMPO CEM (MULTIPLE)

K-Number: K970775 · 1997-06-03

ApplicantForemost Dental Mfg., Inc.
Decision Date1997-06-03
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TEMPO CEM (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 1997-06-03 under 510(k) number K970775. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEMPO CEM (MULTIPLE)?

TEMPO CEM (MULTIPLE) is a medical device that received FDA 510(k) clearance on 1997-06-03. The listed applicant is Foremost Dental Mfg., Inc.. The 510(k) number is K970775.

When did TEMPO CEM (MULTIPLE) receive FDA 510(k) clearance?

TEMPO CEM (MULTIPLE) received FDA 510(k) clearance on 1997-06-03, under 510(k) number K970775.

Who is the listed applicant for TEMPO CEM (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 TEMPO CEM (MULTIPLE)?

The FDA product code for TEMPO CEM (MULTIPLE) is EMA.

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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)K970683ZENTIH FLOWABLE COMPOSITE (MULTIPLE)K970774TEMPOCEM NE (MULTIPLE)K954867IONOSIT SEAL

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Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, 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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