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FDA 510(k)

INSTA-GLAZE

K-Number: K854588 · 1986-02-04

ApplicantGeorge Taub Products & Fusion Co., Inc.
Decision Date1986-02-04
Product CodeEJR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INSTA-GLAZE is the device name listed in this FDA 510(k) record. The listed applicant is George Taub Products & Fusion Co., Inc.. It received FDA 510(k) clearance on 1986-02-04 under 510(k) number K854588. The device is classified under product code EJR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSTA-GLAZE?

INSTA-GLAZE is a medical device that received FDA 510(k) clearance on 1986-02-04. The listed applicant is George Taub Products & Fusion Co., Inc.. The 510(k) number is K854588.

When did INSTA-GLAZE receive FDA 510(k) clearance?

INSTA-GLAZE received FDA 510(k) clearance on 1986-02-04, under 510(k) number K854588.

Who is the listed applicant for INSTA-GLAZE?

The FDA 510(k) record lists George Taub Products & Fusion Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INSTA-GLAZE?

The FDA product code for INSTA-GLAZE is EJR.

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 George Taub Products & Fusion Co., 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.

K833640HYDROXYLINE

Related Devices (Code: EJR)

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.

K171189AIR-FLOW PLUS Prophylaxis powderE.M.S Electro Medical Systems S.AK121698NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMINDentsply International, Inc.K103114OSSPRAY SYLC CROsspray, Ltd.K102053BUTLER CALCI-FLOR PROPHYLAXIS PASTESunstar Americas, Inc.K101104REMIN PROVoco GmbHK100539PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDEPreventive Technologies, 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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