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FDA 510(k)

SCI-PRO, PROPHYLAXIS PASTE

K-Number: K854828 · 1986-03-26

ApplicantScientific Pharmaceuticals, Inc.
Decision Date1986-03-26
Product CodeEJR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SCI-PRO, PROPHYLAXIS PASTE is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1986-03-26 under 510(k) number K854828. 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 SCI-PRO, PROPHYLAXIS PASTE?

SCI-PRO, PROPHYLAXIS PASTE is a medical device that received FDA 510(k) clearance on 1986-03-26. The listed applicant is Scientific Pharmaceuticals, Inc.. The 510(k) number is K854828.

When did SCI-PRO, PROPHYLAXIS PASTE receive FDA 510(k) clearance?

SCI-PRO, PROPHYLAXIS PASTE received FDA 510(k) clearance on 1986-03-26, under 510(k) number K854828.

Who is the listed applicant for SCI-PRO, PROPHYLAXIS PASTE?

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

What is the FDA product code for SCI-PRO, PROPHYLAXIS PASTE?

The FDA product code for SCI-PRO, PROPHYLAXIS PASTE is EJR.

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Other records listing Scientific Pharmaceuticals, 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.

K051952EUGENONEK041886PROVISOK013555SCI-PHARM POST SECUREK001446LIGHT-CURED ORTHODONTIC BAND CEMENTK993324CARBOCEM ZINC POLYCARBOXYLATE CEMENTK982915SCI-PHARM DFV VARNISH

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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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