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FDA 510(k)

ENDO ANALYZER, MODEL 8005

K-Number: K973439 · 1997-12-08

ApplicantSybron Dental Specialties, Inc.
Decision Date1997-12-08
Product CodeEAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENDO ANALYZER, MODEL 8005 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 1997-12-08 under 510(k) number K973439. 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 ENDO ANALYZER, MODEL 8005?

ENDO ANALYZER, MODEL 8005 is a medical device that received FDA 510(k) clearance on 1997-12-08. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K973439.

When did ENDO ANALYZER, MODEL 8005 receive FDA 510(k) clearance?

ENDO ANALYZER, MODEL 8005 received FDA 510(k) clearance on 1997-12-08, under 510(k) number K973439.

Who is the listed applicant for ENDO ANALYZER, MODEL 8005?

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 ENDO ANALYZER, MODEL 8005?

The FDA product code for ENDO ANALYZER, MODEL 8005 is EAT.

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Other records listing Sybron Dental Specialties, 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.

K093341CENTURY MODEL 105CK091091SONICFILL 2010K080089SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPSK073478SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTSK071615FIXAFLOSSK071288MODIFICATION TO KAVO QUATTROCARE

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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.K021298ELEMENTS DIAGNOSTIC UNITSybron Endo/AnalyticK012427PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENTSpecialites SeptodontK011666CHILLITHeatshield, Inc.K990225ENDO ANALYZER, MODEL 8005, MODIFIEDSybron 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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