Cleared Traditional

K121282 - MICROLUX/DL MICROLUX/BLU BIO/SCREEN (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K121282 · Addent, Inc. · Dental device
Jul 2012
Decision
85d
Days
Class 2
Risk

K121282 is an FDA 510(k) clearance for the MICROLUX/DL MICROLUX/BLU 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 July 24, 2012 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K121282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2012
Decision Date July 24, 2012
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 158d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.