Product code MXF— Dental

FDA has cleared 5 devices under product code MXF between 1999 and 2003, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20031 clearance
• 20022 clearances
• 19992 clearances

• Biolase Technology, Inc.4 clearances
• Endo Technic Corp.1 clearance

• K022803 — WATERLASE FOR APICOECTOMYBiolase Technology, Inc.·2003-02-03
• K013908 — WATERLASE MILLENNIUMBiolase Technology, Inc.·2002-02-12
• K012511 — WATERLASE MILLENNIUMBiolase Technology, Inc.·2002-01-18
• K990908 — MILLENNIUMEndo Technic Corp.·1999-05-27
• K990219 — MODIFICATION OF MILLENNIUMBiolase Technology, Inc.·1999-02-24