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FDA 510(k)

ELEMENTS DIAGNOSTIC UNIT

K-Number: K021298 · 2002-06-19

ApplicantSybron Endo/Analytic
Decision Date2002-06-19
Product CodeEAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ELEMENTS DIAGNOSTIC 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 2002-06-19 under 510(k) number K021298. The device is classified under product code EAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELEMENTS DIAGNOSTIC UNIT?

ELEMENTS DIAGNOSTIC UNIT is a medical device that received FDA 510(k) clearance on 2002-06-19. The listed applicant is Sybron Endo/Analytic. The 510(k) number is K021298.

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

ELEMENTS DIAGNOSTIC UNIT received FDA 510(k) clearance on 2002-06-19, under 510(k) number K021298.

Who is the listed applicant for ELEMENTS DIAGNOSTIC 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 DIAGNOSTIC UNIT?

The FDA product code for ELEMENTS DIAGNOSTIC UNIT is EAT.

Related Clinical Trials

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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.

K031664ELEMENTS OBTURATION UNITK021253ULTRASONIC TIPS WITH DIAMOND COATING

Related Devices (Code: EAT)

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.

K022097THERMIQUEParkell, Inc.K012427PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENTSpecialites SeptodontK011666CHILLITHeatshield, Inc.K990225ENDO ANALYZER, MODEL 8005, MODIFIEDSybron Dental Specialties, Inc.K973439ENDO ANALYZER, MODEL 8005Sybron Dental Specialties, Inc.K970715SYSTEM B HEAT SOURCESybron Dental Specialties, 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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