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FDA 510(k)

FLEXI-FLOW CEMENT WITH TITANIUM

K-Number: K922250 · 1994-01-26

ApplicantEssential Dental Systems, Inc.
Decision Date1994-01-26
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FLEXI-FLOW CEMENT WITH TITANIUM is the device name listed in this FDA 510(k) record. The listed applicant is Essential Dental Systems, Inc.. It received FDA 510(k) clearance on 1994-01-26 under 510(k) number K922250. 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 FLEXI-FLOW CEMENT WITH TITANIUM?

FLEXI-FLOW CEMENT WITH TITANIUM is a medical device that received FDA 510(k) clearance on 1994-01-26. The listed applicant is Essential Dental Systems, Inc.. The 510(k) number is K922250.

When did FLEXI-FLOW CEMENT WITH TITANIUM receive FDA 510(k) clearance?

FLEXI-FLOW CEMENT WITH TITANIUM received FDA 510(k) clearance on 1994-01-26, under 510(k) number K922250.

Who is the listed applicant for FLEXI-FLOW CEMENT WITH TITANIUM?

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

What is the FDA product code for FLEXI-FLOW CEMENT WITH TITANIUM?

The FDA product code for FLEXI-FLOW CEMENT WITH TITANIUM is EMA.

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Other records listing Essential Dental Systems, 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.

K223340EDS Calculus Softener TURBO CRK152691EDS Universal CementK111541ENDO-EXPRESS (R) HANDPIECEK101504TI-CORE FLOWK072555EDTA PLUSK070401ENDO-CHX

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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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