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FDA 510(k)

FLEXI-CAST CROWN CORE SYSTEM

K-Number: K896693 · 1990-02-14

ApplicantEssential Dental Systems, Inc.
Decision Date1990-02-14
Product CodeELR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FLEXI-CAST CROWN CORE SYSTEM 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 1990-02-14 under 510(k) number K896693. The device is classified under product code ELR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXI-CAST CROWN CORE SYSTEM?

FLEXI-CAST CROWN CORE SYSTEM is a medical device that received FDA 510(k) clearance on 1990-02-14. The listed applicant is Essential Dental Systems, Inc.. The 510(k) number is K896693.

When did FLEXI-CAST CROWN CORE SYSTEM receive FDA 510(k) clearance?

FLEXI-CAST CROWN CORE SYSTEM received FDA 510(k) clearance on 1990-02-14, under 510(k) number K896693.

Who is the listed applicant for FLEXI-CAST CROWN CORE SYSTEM?

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-CAST CROWN CORE SYSTEM?

The FDA product code for FLEXI-CAST CROWN CORE SYSTEM is ELR.

Related Clinical Trials

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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: ELR)

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.

K060075FIBER-METAL POSTForemost Dental, LLCK042848FRC POSTEC PLUSIvoclar Vivadent, Inc.K030820EVERSTICK POSTStick Tech , Ltd.K020431FIBIOCOREEst. AnthogyrK012496CARBON POSTJ. Morita USA, Inc.K013802FRC POSTECIvoclar Vivadent, 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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