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FDA 510(k)

QUANTEC-E ENDO SYSTEM

K-Number: K990739 · 1999-05-26

ApplicantSybron Dental Specialties, Inc.
Decision Date1999-05-26
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

QUANTEC-E ENDO SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Dental Specialties, Inc.. It received FDA 510(k) clearance on 1999-05-26 under 510(k) number K990739. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTEC-E ENDO SYSTEM?

QUANTEC-E ENDO SYSTEM is a medical device that received FDA 510(k) clearance on 1999-05-26. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K990739.

When did QUANTEC-E ENDO SYSTEM receive FDA 510(k) clearance?

QUANTEC-E ENDO SYSTEM received FDA 510(k) clearance on 1999-05-26, under 510(k) number K990739.

Who is the listed applicant for QUANTEC-E ENDO SYSTEM?

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

What is the FDA product code for QUANTEC-E ENDO SYSTEM?

The FDA product code for QUANTEC-E ENDO SYSTEM is EKX.

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Other records listing Sybron Dental Specialties, Inc. as applicant

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Related Devices (Code: EKX)

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.

K261987Reusable SmartPegOsstell ABK252223Alpha Endo Handpiece (Alpha Endo)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K251597InnerView SystemPerimetrics, Inc.K243692EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L.K242514Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)Shenzhen Rogin Medical Co., Ltd.K241065ChecQ (AC100)Dentis Co., Ltd.

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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