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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d faster than avg
Panel avg: 128d · 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 31
Devices cleared under the same product code (EIE) and FDA review panel - the closest regulatory comparables to K040797.
Triumph Resin Dam
K151945 · Denali Corporation · Feb 2016
BARI-KAD PACKING DEVICE
K050318 · Bioenvelop Agro, Inc. · Mar 2005
GC TION GINGIVAL PROTECTOR
K043301 · GC America, Inc. · Jan 2005
PULPDENT PUTTY DAM
K022522 · Pulpdent Corporation · Sep 2002
LIGHT CURE DENTAL DAM
K021524 · Prime Dental Manufacturing, Inc. · Jul 2002
NIVEOUS LIQUID DAM
K021613 · Shofu Dental Corp. · Jun 2002
K040797 · BRITESMILE MASKING CREAM
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