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510(k) K012511

WATERLASE MILLENNIUM by Biolase Technology, Inc. — Product Code MXF

K012511 is an FDA 510(k) premarket notification submitted by Biolase Technology, Inc. for the device "WATERLASE MILLENNIUM". The FDA issued a decision of Substantially Equivalent on January 18, 2002. The device falls under product code MXF (System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation), a Class II device regulated under 21 CFR 872.4120. Biolase Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2002
Date Received
August 6, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type

Other clearances by Biolase Technology, Inc.

  • K122368 — WATERLASE IPLUS ALL TISSUE LASER (May 2, 2013)
  • K130465 — EPIC 10S (April 11, 2013)
  • K121327 — DIOLASE 10S (February 1, 2013)
  • K121286 — EPIC 10 (September 28, 2012)
  • K101658 — WATERLASE MD TURBO PLUS MODEL 7200XXX (August 11, 2010)
  • K093852 — EZLASE 3 LASER SYSTEM (March 12, 2010)
  • K091746 — WATERLASE MD, MODEL 7100102 (December 7, 2009)
  • K083927 — WATERLASE MD (October 1, 2009)
  • K091922 — WATERLASE C100, MODEL 7100104 (July 14, 2009)
  • K083595 — EZLASE (April 14, 2009)

Other clearances for product code MXF

  • K022803 — WATERLASE FOR APICOECTOMY (February 3, 2003)
  • K013908 — WATERLASE MILLENNIUM (February 12, 2002)
  • K990908 — MILLENNIUM (May 27, 1999)
  • K990219 — MODIFICATION OF MILLENNIUM (February 24, 1999)

FDA data resources