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FDA 510(k)

ORAJEL ADVANCED TOOTH DESENSITIZER

K-Number: K041680 · 2004-11-10

ApplicantDel Pharmaceuticals, Inc.
Decision Date2004-11-10
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORAJEL ADVANCED TOOTH DESENSITIZER is the device name listed in this FDA 510(k) record. The listed applicant is Del Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2004-11-10 under 510(k) number K041680. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORAJEL ADVANCED TOOTH DESENSITIZER?

ORAJEL ADVANCED TOOTH DESENSITIZER is a medical device that received FDA 510(k) clearance on 2004-11-10. The listed applicant is Del Pharmaceuticals, Inc.. The 510(k) number is K041680.

When did ORAJEL ADVANCED TOOTH DESENSITIZER receive FDA 510(k) clearance?

ORAJEL ADVANCED TOOTH DESENSITIZER received FDA 510(k) clearance on 2004-11-10, under 510(k) number K041680.

Who is the listed applicant for ORAJEL ADVANCED TOOTH DESENSITIZER?

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

What is the FDA product code for ORAJEL ADVANCED TOOTH DESENSITIZER?

The FDA product code for ORAJEL ADVANCED TOOTH DESENSITIZER is KLE.

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Related Devices (Code: KLE)

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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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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