Cleared Traditional

K012511 - WATERLASE MILLENNIUM

K012511 is an FDA 510(k) clearance for WATERLASE MILLENNIUM, manufactured by Biolase Technology, Inc.. The device is a Class 2 Dental device with product code MXF cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K012511 · Biolase Technology, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
165d
Days
Class 2
Risk

K012511 is an FDA 510(k) clearance for the WATERLASE MILLENNIUM. Classified as System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation (product code MXF), Class II - Special Controls.

Submitted by Biolase Technology, Inc. (Clemente, US). The FDA issued a Cleared decision on January 18, 2002 after a review of 165 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4120 - 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 Biolase Technology, Inc. devices

FDA 510(k) Submission Details - K012511

510(k) Number K012511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2001
Decision Date January 18, 2002
Days to Decision 165 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
38d slower than avg
Panel avg: 127d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MXF Device Classification - Class 2, Special Controls

Product Code MXF System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
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.