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FDA 510(k)

ULTRA II PORCELAIN POLISHING PASTE

K-Number: K896071 · 1990-08-14

ApplicantShofu Dental Corp.
Decision Date1990-08-14
Product CodeEJR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULTRA II PORCELAIN POLISHING PASTE is the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corp.. It received FDA 510(k) clearance on 1990-08-14 under 510(k) number K896071. 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 ULTRA II PORCELAIN POLISHING PASTE?

ULTRA II PORCELAIN POLISHING PASTE is a medical device that received FDA 510(k) clearance on 1990-08-14. The listed applicant is Shofu Dental Corp.. The 510(k) number is K896071.

When did ULTRA II PORCELAIN POLISHING PASTE receive FDA 510(k) clearance?

ULTRA II PORCELAIN POLISHING PASTE received FDA 510(k) clearance on 1990-08-14, under 510(k) number K896071.

Who is the listed applicant for ULTRA II PORCELAIN POLISHING PASTE?

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

What is the FDA product code for ULTRA II PORCELAIN POLISHING PASTE?

The FDA product code for ULTRA II PORCELAIN POLISHING PASTE is EJR.

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Other records listing Shofu Dental 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.

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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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