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FDA 510(k)

SWIRL PROPHYLAXIS PASTE

K-Number: K903986 · 1991-03-28

ApplicantBio-Medica Concepts
Decision Date1991-03-28
Product CodeEJR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SWIRL PROPHYLAXIS PASTE is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Medica Concepts. It received FDA 510(k) clearance on 1991-03-28 under 510(k) number K903986. 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 SWIRL PROPHYLAXIS PASTE?

SWIRL PROPHYLAXIS PASTE is a medical device that received FDA 510(k) clearance on 1991-03-28. The listed applicant is Bio-Medica Concepts. The 510(k) number is K903986.

When did SWIRL PROPHYLAXIS PASTE receive FDA 510(k) clearance?

SWIRL PROPHYLAXIS PASTE received FDA 510(k) clearance on 1991-03-28, under 510(k) number K903986.

Who is the listed applicant for SWIRL PROPHYLAXIS PASTE?

The FDA 510(k) record lists Bio-Medica Concepts as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SWIRL PROPHYLAXIS PASTE?

The FDA product code for SWIRL PROPHYLAXIS PASTE is EJR.

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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

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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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