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FDA 510(k)

HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER

K-Number: K854795 · 1986-03-04

ApplicantFran Hazelton Co.
Decision Date1986-03-04
Product CodeEIS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER is the device name listed in this FDA 510(k) record. The listed applicant is Fran Hazelton Co.. It received FDA 510(k) clearance on 1986-03-04 under 510(k) number K854795. The device is classified under product code EIS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER?

HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER is a medical device that received FDA 510(k) clearance on 1986-03-04. The listed applicant is Fran Hazelton Co.. The 510(k) number is K854795.

When did HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER receive FDA 510(k) clearance?

HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER received FDA 510(k) clearance on 1986-03-04, under 510(k) number K854795.

Who is the listed applicant for HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER?

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

What is the FDA product code for HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER?

The FDA product code for HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER is EIS.

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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Related Devices (Code: EIS)

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.

K992649ATD AUTOMATIC BRIDGE REMOVERJ. Morita USA, Inc.K951299EASY PNEUMATIC CROWN AND BRIDGE REMOVERDentco, Inc.K863500STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CARPacific Union Dental, Inc.K842026H-TYPE BRIDGE REMOVERHiga Manufacturing , Ltd.K833290C & B 40 PENTRO C & B40Genesis Industries, Inc.K833287SATIN CAST ECONOCASTGenesis Industries, 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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