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FDA 510(k)

PULPDENT DIAMOND POLISH

K-Number: K911284 · 1991-05-30

ApplicantPulpdent Corp.
Decision Date1991-05-30
Product CodeEJR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PULPDENT DIAMOND POLISH is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corp.. It received FDA 510(k) clearance on 1991-05-30 under 510(k) number K911284. 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 PULPDENT DIAMOND POLISH?

PULPDENT DIAMOND POLISH is a medical device that received FDA 510(k) clearance on 1991-05-30. The listed applicant is Pulpdent Corp.. The 510(k) number is K911284.

When did PULPDENT DIAMOND POLISH receive FDA 510(k) clearance?

PULPDENT DIAMOND POLISH received FDA 510(k) clearance on 1991-05-30, under 510(k) number K911284.

Who is the listed applicant for PULPDENT DIAMOND POLISH?

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 PULPDENT DIAMOND POLISH?

The FDA product code for PULPDENT DIAMOND POLISH 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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