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FDA 510(k)

DENTAL CHEWING GUM (SUGARLESS)

K-Number: K810037 · 1981-04-08

ApplicantMcdennan Oral Products, Inc.
Decision Date1981-04-08
Product CodeEJR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL CHEWING GUM (SUGARLESS) is the device name listed in this FDA 510(k) record. The listed applicant is Mcdennan Oral Products, Inc.. It received FDA 510(k) clearance on 1981-04-08 under 510(k) number K810037. 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 DENTAL CHEWING GUM (SUGARLESS)?

DENTAL CHEWING GUM (SUGARLESS) is a medical device that received FDA 510(k) clearance on 1981-04-08. The listed applicant is Mcdennan Oral Products, Inc.. The 510(k) number is K810037.

When did DENTAL CHEWING GUM (SUGARLESS) receive FDA 510(k) clearance?

DENTAL CHEWING GUM (SUGARLESS) received FDA 510(k) clearance on 1981-04-08, under 510(k) number K810037.

Who is the listed applicant for DENTAL CHEWING GUM (SUGARLESS)?

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

What is the FDA product code for DENTAL CHEWING GUM (SUGARLESS)?

The FDA product code for DENTAL CHEWING GUM (SUGARLESS) is EJR.

Related Clinical Trials

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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Other records listing Mcdennan Oral Products, 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.

K810279DENTURE CLEANER

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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