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FDA 510(k)

TI-CORE FLOW

K-Number: K101504 · 2010-10-29

ApplicantEssential Dental Systems, Inc.
Decision Date2010-10-29
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TI-CORE FLOW 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 2010-10-29 under 510(k) number K101504. 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 TI-CORE FLOW?

TI-CORE FLOW is a medical device that received FDA 510(k) clearance on 2010-10-29. The listed applicant is Essential Dental Systems, Inc.. The 510(k) number is K101504.

When did TI-CORE FLOW receive FDA 510(k) clearance?

TI-CORE FLOW received FDA 510(k) clearance on 2010-10-29, under 510(k) number K101504.

Who is the listed applicant for TI-CORE FLOW?

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 TI-CORE FLOW?

The FDA product code for TI-CORE FLOW is EMA.

Other records listing Essential Dental Systems, Inc. as applicant

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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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