FDA.reportPublic FDA data

BIOLASE MG LLC

Matched from indexed company URL: Biolase Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20277552027755BIOLASE MG LLC1N2026-01-0127042 Towne Centre Drive Suite 270 Foothill Ranch CA US 92610
30171251613017125161BIOLASE MG LLC1N2026-01-014225 Prado Road Suite 102 Corona CA US 92880
20277552027755BIOLASE, INC.1N2020-04-254 CROMWELL Irvine CA US 92618

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00647529003763Waterlase Laser Tips - A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.1-800-321-6717Waterlaseservice@biolase.com
00647529003787Waterlase iPlus Dental Laser System - A kit including a handpiece and tips intended to be utilized with an all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories (protective eyewear, power cords, tip cleaning kit). The patient-contacting components of the delivery system require sterilization prior to use.1-800-321-6717Waterlaseservice@biolase.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3356621633898231K213428EdgeProNVK2021-12-22
3357241633898231K213428EdgeProNVK2021-12-22
3357241776142385K210183Waterlase iPLusGEX2022-04-21
3356621776142385K210183Waterlase iPLusGEX2022-04-21
3357241343822897K192430Epic 980GEX2019-12-04
3356621343822897K192430Epic 980GEX2019-12-04
791801518440958K192430Epic 980GEX2019-12-04
791801403005809K172771Epic Pro 940GEX2017-11-29
3356622067314539K172771Epic Pro 940GEX2017-11-29
3357242067314539K172771Epic Pro 940GEX2017-11-29
791801020706877K163128Epic ProGEX2017-01-11
3357241214287592K163128Epic ProGEX2017-01-11
3356621214287592K163128Epic ProGEX2017-01-11
3357241568277975K161669Waterlase ExpressGEX2016-07-28
3356621568277975K161669Waterlase ExpressGEX2016-07-28
791801870622965K161669Waterlase ExpressGEX2016-07-28
3356621271135530K130465EPIC 10SGEX2013-04-11
3357241271135530K130465EPIC 10SGEX2013-04-11
791801729549630K130465EPIC 10SGEX2013-04-11
3356621343740127K121286EPIC 10GEX2012-09-28
3357241343740127K121286EPIC 10GEX2012-09-28
791801389476202K121286EPIC 10GEX2012-09-28
3356621075494269K101658WATERLASE MD TURBO PLUS MODEL 7200XXXGEX2010-08-11
3357241075494269K101658WATERLASE MD TURBO PLUS MODEL 7200XXXGEX2010-08-11
791801403911116K101658WATERLASE MD TURBO PLUS MODEL 7200XXXGEX2010-08-11
3357241437286504K093852EZLASE 3 LASER SYSTEMGEX2010-03-12
3356621437286504K093852EZLASE 3 LASER SYSTEMGEX2010-03-12
791801786961999K093852EZLASE 3 LASER SYSTEMGEX2010-03-12
791801083047480K090181WATERLASE MDGEX2009-02-11
3356621752381985K090181WATERLASE MDGEX2009-02-11
3357241752381985K090181WATERLASE MDGEX2009-02-11
3356621238772526K031140WATERLASEGEX2004-07-07
3357241238772526K031140WATERLASEGEX2004-07-07
791801647900206

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX312022-04-21
NVK22021-12-22

PMN#

EPIC 10S

2013-04-11

BIOLASE TECHNOLOGY, INC.

EPIC 10

2012-09-28

BIOLASE TECHNOLOGY, INC.

EZLASE

2009-04-14

Biolase Technology, Inc.

EZLASE

2008-12-22

Biolase Technology, Inc.

EZLASE

2007-01-26

BIOLASE TECHNOLOGY, INC.

TWILIGHT

1999-09-10

BIOLASE TECHNOLOGY, INC.

GUDID#

Waterlase iPlus Dental Laser System - A kit including a handpiece and tips intended to be utilized with an all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories (protective eyewear, power cords, tip cleaning kit). The patient-contacting components of the delivery system require sterilization prior to use.

Biolase, Inc.

2023-08-01

200 records. Showing 1-40. Next