Cleared Traditional

BRITESMILE BARRIER MATERIAL (K010935) - FDA 510(k) Clearance

Class I Dental device.

K010935 · Britesmile, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
161d
Days
Class 1
Risk

K010935 is an FDA 510(k) clearance for the BRITESMILE BARRIER MATERIAL. 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 September 5, 2001 after a review of 161 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6300 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Britesmile, Inc. devices

Submission Details

510(k) Number K010935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2001
Decision Date September 05, 2001
Days to Decision 161 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 127d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.