Cleared Traditional

K082668 - BIO-SCREEN

K082668 is an FDA 510(k) clearance for BIO-SCREEN, manufactured by Addent, Inc.. The device is a Class 2 Dental device with product code NXV cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K082668 · Addent, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
133d
Days
Class 2
Risk

K082668 is an FDA 510(k) clearance for the BIO-SCREEN. Classified as Diagnostic Light, Soft Tissue Detector (product code NXV), Class II - Special Controls.

Submitted by Addent, Inc. (Danbury, US). The FDA issued a Cleared decision on January 23, 2009 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6350 - 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.

FDA 510(k) Submission Details - K082668

510(k) Number K082668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2008
Decision Date January 23, 2009
Days to Decision 133 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 128d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NXV Device Classification - Class 2, Special Controls

Product Code NXV Diagnostic Light, Soft Tissue Detector
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6350
Definition To Be Used As An Aid In The Detection Or Visualization Of Abnormalities Of Intraoral Soft Tissue. An Adjunct To Traditional Intraoral Examination By Incandescent Light To Enhance The Visualization Of Oral Mucosal Abnormalities
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NXV Diagnostic Light, Soft Tissue Detector

All 11
Devices cleared under the same product code (NXV) and FDA review panel - the closest regulatory comparables to K082668.
VELSCOPE VX
K102083 · Led Dental, Inc. · Nov 2010
DENTLIGHT ORAL EXAM LIGHT KIT
K101140 · Dentlight, Inc. · Jul 2010
TRIMIRA IDENTAFI 3000
K090135 · Remicalm, LLC · Feb 2009
TRIMIRA OCS 3000
K082603 · Remicalm, LLC · Dec 2008
VIZILITE EYEWEAR
K080043 · Zila, Inc. · Apr 2008
SAPPHIRE O/E ORAL EXAMINATION SYSTEM
K073483 · Den-Mat Holdings, LLC · Apr 2008