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FDA 510(k)

ORTHO-ICE

K-Number: K960799 · 1996-05-09

ApplicantUltimate Wireforms, Inc.
Decision Date1996-05-09
Product CodeEAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHO-ICE is the device name listed in this FDA 510(k) record. The listed applicant is Ultimate Wireforms, Inc.. It received FDA 510(k) clearance on 1996-05-09 under 510(k) number K960799. 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 ORTHO-ICE?

ORTHO-ICE is a medical device that received FDA 510(k) clearance on 1996-05-09. The listed applicant is Ultimate Wireforms, Inc.. The 510(k) number is K960799.

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

ORTHO-ICE received FDA 510(k) clearance on 1996-05-09, under 510(k) number K960799.

Who is the listed applicant for ORTHO-ICE?

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

What is the FDA product code for ORTHO-ICE?

The FDA product code for ORTHO-ICE is EAT.

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 Ultimate Wireforms, 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.

K924805ORTHODONTIC ARCH WIREK923837DIMPLED MULTI MODULUS ARCH WIREK923836.016' X .016 NICKEL TITANIUM UPRIGHTING SPRINGK923838THE ULTIMATE RCS ARCH WIREK923839NITINOL GENTLE TOUCH COIL SPRING

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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