510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013908Substantially Equivalent

Waterlase Millennium

Biolase MG LLC, Clemente CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013908 is the FDA 510(k) clearance record for WATERLASE MILLENNIUM, a class II device, cleared for Biolase Technology, Inc. on under FDA product code MXF (System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation). FDA records list 31 510(k) clearances for BIOLASE MG LLC, from to . As of , FDA records show no recalls naming K013908.

Clearance record

Decision date
Received
(78 days to decision)
Product code
MXF System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation
Regulation
21 CFR 872.4120
Device class
Class II
Review panel
Dental
Applicant
Biolase Technology, Inc. 981 Calle Amanecer, Clemente CA
510(k) summary
Summary
Third party review
No

Clearances, product code MXF

Trailing 12 months

FDA records hold no clearances under product code MXF in the trailing twelve months.

FDA records show no clearances under product code MXF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MXF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260