laserwhite20 Whitening Gel 7400030

GUDID 00647529000113

laserwhite20 Whitening Gel contains 5 patient treatment kits. Each kit contains one syringe of whitening gel base, one syringe of gel activator, one syringe of liquid dam and one syringe of desensitizer. Accessories such as applicators are also included. The product is intended for use with Biolase diode lasers.

BIOLASE, INC.

Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing
Primary Device ID00647529000113
NIH Device Record Keyc1a7ebb0-ea65-44cb-afd6-79ec10edaf9c
Commercial Distribution StatusIn Commercial Distribution
Brand Namelaserwhite20 Whitening Gel
Version Model Numberlaserwhite20
Catalog Number7400030
Company DUNS152165700
Company NameBIOLASE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100647529000113 [Primary]
GS100647529000281 [Package]
Package: Carton [5 Units]
In Commercial Distribution

FDA Product Code

LBHVarnish, Cavity

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-02-07
Device Publish Date2016-12-13

Devices Manufactured by BIOLASE, INC.

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00647529003770 - Waterlase iPlus Dental Laser System2023-08-09 A handpiece utilized with an all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. Th
00647529003787 - Waterlase iPlus Dental Laser System2023-08-09 A kit including a handpiece and tips intended to be utilized with an all-tissue dental laser system intended for a variety of so
00647529000120 - Diode Laser Tips2023-06-27 A single-use fiberoptic laser tip intended for use with Biolase diode laser systems.
00647529000137 - Diode Laser Tips2023-06-27 A single-use fiberoptic laser tip intended for use with Biolase diode laser systems.
00647529000687 - Waterlase Laser Tips 2023-06-27 A single-use fiberoptic accessory intended for use with Waterlase Laser delivery systems.
00647529000922 - Waterlase Laser Tips 2023-06-27 A single-use fiberoptic accessory intended for use with Waterlase Laser delivery systems.
00647529001509 - Waterlase Express Handpiece 2023-06-27 A reusable handpiece intended for use with the Waterlase Express Laser System in a variety of dental hard-tissue and soft-tissue

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