510(k) K990219

Device: MODIFICATION OF MILLENNIUM
Applicant: BIOLASE TECHNOLOGY, INC.
510(k) number: K990219
Product code: MXF
Decision: Substantially Equivalent (SESE)
Decision date: 1999-02-24
Date received: 1999-01-22
Regulation: 872.4120
Classification name: System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation
Medical specialty: Dental
Review panel: Dental
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: ANDREW KIMMEL
Address: 981 Calle Amanecer Clemente CA US 92673 92673

FDA Registration Numbers#

3017125161
2027755

Source Documents#

Other 510(k) Records For Product Code MXF #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K022803	WATERLASE FOR APICOECTOMY	Biolase Technology, Inc.	2003-02-03
K013908	WATERLASE MILLENNIUM	Biolase Technology, Inc.	2002-02-12
K012511	WATERLASE MILLENNIUM	Biolase Technology, Inc.	2002-01-18
K990908	MILLENNIUM	Endo Technic Corp.	1999-05-27

Legacy Summary#

summary

FDA Review#

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