Cleared Traditional

K010935 - BRITESMILE BARRIER MATERIAL

K010935 is an FDA 510(k) clearance for BRITESMILE BARRIER MATERIAL, manufactured by Britesmile, Inc.. The device is a Class 1 Dental device with product code EIE cleared through the Traditional 510(k) pathway after a 161-day FDA review.

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

FDA 510(k) Submission Details - K010935

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.

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
Devices cleared under the same product code (EIE) and FDA review panel - the closest regulatory comparables to K010935.
GC TION GINGIVAL PROTECTOR
K043301 · GC America, Inc. · Jan 2005
PULPDENT PUTTY DAM
K022522 · Pulpdent Corporation · Sep 2002
NIVEOUS LIQUID DAM
K021613 · Shofu Dental Corp. · Jun 2002
POWER BLOCK
K983227 · Kreativ, Inc. · Dec 1998
FASTDAM
K972775 · Interdent, Inc. · Feb 1998
DENTAL DAM SILICONE
K961472 · Worldwide Dental, Inc. · Aug 1996