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FDA 510(k)

KEN'S PROPHY GEL - REGULAR

K-Number: K896661 · 1990-02-14

ApplicantPulpdent Corp.
Decision Date1990-02-14
Product CodeEJR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KEN'S PROPHY GEL - REGULAR is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corp.. It received FDA 510(k) clearance on 1990-02-14 under 510(k) number K896661. 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 KEN'S PROPHY GEL - REGULAR?

KEN'S PROPHY GEL - REGULAR is a medical device that received FDA 510(k) clearance on 1990-02-14. The listed applicant is Pulpdent Corp.. The 510(k) number is K896661.

When did KEN'S PROPHY GEL - REGULAR receive FDA 510(k) clearance?

KEN'S PROPHY GEL - REGULAR received FDA 510(k) clearance on 1990-02-14, under 510(k) number K896661.

Who is the listed applicant for KEN'S PROPHY GEL - REGULAR?

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

What is the FDA product code for KEN'S PROPHY GEL - REGULAR?

The FDA product code for KEN'S PROPHY GEL - REGULAR is EJR.

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Other records listing Pulpdent 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.

K014138PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENTK014133PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVEK020115PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEMK014059PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVEK013411PULPDENT CAVITY PREPARATION IVK994180PULPDENT CAVITY PREPARATION III

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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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