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FDA 510(k)

ENDO-ICE

K-Number: K881826 · 1988-08-23

ApplicantThe Hygenic Corp.
Decision Date1988-08-23
Product CodeEAT
Advisory CommitteeDE
DecisionSubstantially Equivalent for Some Indications

Device Summary

ENDO-ICE is the device name listed in this FDA 510(k) record. The listed applicant is The Hygenic Corp.. It received FDA 510(k) clearance on 1988-08-23 under 510(k) number K881826. The device is classified under product code EAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the ENDO-ICE?

ENDO-ICE is a medical device that received FDA 510(k) clearance on 1988-08-23. The listed applicant is The Hygenic Corp.. The 510(k) number is K881826.

When did ENDO-ICE receive FDA 510(k) clearance?

ENDO-ICE received FDA 510(k) clearance on 1988-08-23, under 510(k) number K881826.

Who is the listed applicant for ENDO-ICE?

The FDA 510(k) record lists The Hygenic Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDO-ICE?

The FDA product code for ENDO-ICE is EAT.

Other records listing The Hygenic Corp. 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.

K954990DENTAL DAMK930764ENDO-ICE-PULP TESTER-THERMALK905418GATES GLIDDEN DRILLSK911225TRAY DOUGHK905640SOLID CORE GUTTA PERCHA CARRIERK900301NOVUS BONDING AGENT

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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.K973439ENDO ANALYZER, MODEL 8005Sybron 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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