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FDA 510(k)

AQUAFRESH PLAQUE FIGHTING GUM

K-Number: K944575 · 1994-12-15

Decision Date1994-12-15
Product CodeEJR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AQUAFRESH PLAQUE FIGHTING GUM is the device name listed in this FDA 510(k) record. The listed applicant is Smithkline Beecham Consumer Healthcare Products. It received FDA 510(k) clearance on 1994-12-15 under 510(k) number K944575. 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 AQUAFRESH PLAQUE FIGHTING GUM?

AQUAFRESH PLAQUE FIGHTING GUM is a medical device that received FDA 510(k) clearance on 1994-12-15. The listed applicant is Smithkline Beecham Consumer Healthcare Products. The 510(k) number is K944575.

When did AQUAFRESH PLAQUE FIGHTING GUM receive FDA 510(k) clearance?

AQUAFRESH PLAQUE FIGHTING GUM received FDA 510(k) clearance on 1994-12-15, under 510(k) number K944575.

Who is the listed applicant for AQUAFRESH PLAQUE FIGHTING GUM?

The FDA 510(k) record lists Smithkline Beecham Consumer Healthcare Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AQUAFRESH PLAQUE FIGHTING GUM?

The FDA product code for AQUAFRESH PLAQUE FIGHTING GUM 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.

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.

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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