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

• Primary Device ID: 00647529000113
• NIH Device Record Key: c1a7ebb0-ea65-44cb-afd6-79ec10edaf9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: laserwhite20 Whitening Gel
• Version Model Number: laserwhite20
• Catalog Number: 7400030
• Company DUNS: 152165700
• Company Name: BIOLASE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00647529000113 [Primary]
GS1	00647529000281 [Package]; Package: Carton [5 Units]; In Commercial Distribution

FDA Product Code

• LBH: Varnish, Cavity

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-12-13

Devices Manufactured by BIOLASE, INC.

• 00647529004722 - Waterlase iPlus Dental Laser System: 2025-02-10 An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser
• 00647529004777 - Waterlase iPlus Dental Laser System: 2025-02-10 An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser
• 00647529004647 - Diode Laser Tips: 2024-05-07 An assortment kit composed of thirty single-use fiberoptic laser tip intended for use with Biolase diode laser systems.
• 00647529003749 - Waterlase Laser Tips: 2023-08-09 A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
• 00647529003770 - Waterlase iPlus Dental Laser System: 2023-08-09 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 System: 2023-08-09 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 Tips: 2023-06-27 A single-use fiberoptic laser tip intended for use with Biolase diode laser systems.
• 00647529000137 - Diode Laser Tips: 2023-06-27 A single-use fiberoptic laser tip intended for use with Biolase diode laser systems.