MXF — System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation Class II

FDA Device Classification

FDA product code MXF covers "System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation", a Class II medical device regulated under 21 CFR 872.4120. Submissions are reviewed by the Dental panel. At least 5 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
MXF
Device Class
Class II
Regulation Number
872.4120
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K022803biolase technologyWATERLASE FOR APICOECTOMYFebruary 3, 2003
K013908biolase technologyWATERLASE MILLENNIUMFebruary 12, 2002
K012511biolase technologyWATERLASE MILLENNIUMJanuary 18, 2002
K990908endo technicMILLENNIUMMay 27, 1999
K990219biolase technologyMODIFICATION OF MILLENNIUMFebruary 24, 1999