Millennium

FDA 510(k) K990908 · Endo Technic Corp.

Substantially Equivalent

510(k) numberK990908

Submission

Device name
Millennium
Applicant
Endo Technic Corp.
San Clemente, CA, US
Received
March 18, 1999
Decision date
May 27, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MXF – System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation
Device class
Class II (moderate risk)
Regulation
21 CFR 872.4120
Specialty
Dental

Other 510(k)s with product code MXF

510(k)DeviceApplicantDecision
K022803Waterlase for ApicoectomyMXF · Traditional Biolase Technology, Inc.02/03/2003SE
K013908Waterlase MillenniumMXF · Traditional Biolase Technology, Inc.02/12/2002SE
K012511Waterlase MillenniumMXF · Traditional Biolase Technology, Inc.01/18/2002SE
K990219Modification of MillenniumMXF · Traditional Biolase Technology, Inc.02/24/1999SE

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Questions and answers

When was Millennium cleared by the FDA?

Millennium (K990908) received a 510(k) decision of Substantially Equivalent on May 27, 1999, 70 days after the submission was received.

What is the product code of K990908?

The FDA product code is MXF – System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation, a Class II (moderate risk) device regulated under 21 CFR 872.4120.