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FDA 510(k)

ELEMENTS OBTURATION UNIT

K-Number: K031664 · 2004-04-28

ApplicantSybron Endo/Analytic
Decision Date2004-04-28
Product CodeEKR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ELEMENTS OBTURATION UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Endo/Analytic. It received FDA 510(k) clearance on 2004-04-28 under 510(k) number K031664. The device is classified under product code EKR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELEMENTS OBTURATION UNIT?

ELEMENTS OBTURATION UNIT is a medical device that received FDA 510(k) clearance on 2004-04-28. The listed applicant is Sybron Endo/Analytic. The 510(k) number is K031664.

When did ELEMENTS OBTURATION UNIT receive FDA 510(k) clearance?

ELEMENTS OBTURATION UNIT received FDA 510(k) clearance on 2004-04-28, under 510(k) number K031664.

Who is the listed applicant for ELEMENTS OBTURATION UNIT?

The FDA 510(k) record lists Sybron Endo/Analytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELEMENTS OBTURATION UNIT?

The FDA product code for ELEMENTS OBTURATION UNIT is EKR.

Related Clinical Trials

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.

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Other records listing Sybron Endo/Analytic 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.

K021253ULTRASONIC TIPS WITH DIAMOND COATINGK021298ELEMENTS DIAGNOSTIC UNIT

Related Devices (Code: EKR)

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.

K060347B&L L-BETA, MODEL WL-B1B&L Biotech Co., Ltd.K042828OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700Young O/S, LLCK860569ENDODONTIC ROOT CANAL PLUGGERDentsply Intl.K831748ENDODONTIC ROOT CANAL PLUGGER FINGER-Union BranchK791019MCSPADDEN CONDENSORTechdent, 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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