Cleared Special

K040797 - BRITESMILE MASKING CREAM

K040797 is an FDA 510(k) clearance for BRITESMILE MASKING CREAM, manufactured by Britesmile, Inc.. The device is a Class 1 Dental device with product code EIE cleared through the Special 510(k) pathway after a 4-day FDA review.

K040797 · Britesmile, Inc. · Dental device
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Apr 2004
Decision
4d
Days
Class 1
Risk

K040797 is an FDA 510(k) clearance for the BRITESMILE MASKING CREAM. Classified as Dam, Rubber (product code EIE), Class I - General Controls.

Submitted by Britesmile, Inc. (North Attleboro, US). The FDA issued a Cleared decision on April 2, 2004 after a review of 4 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6300 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Britesmile, Inc. devices

FDA 510(k) Submission Details - K040797

510(k) Number K040797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2004
Decision Date April 02, 2004
Days to Decision 4 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 127d · This submission: 4d
Pathway characteristics
Modification to existing cleared device.

EIE Device Classification - Class 1, General Controls

Product Code EIE Dam, Rubber
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EIE Dam, Rubber

All 12
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