Whitening Handpiece Disposable Shields 6400180

GUDID 00647529002711

Disposable shields are single-use, non-sterile, clear plastic protective covers intended for and specifically designed for use with the Biolase Whitening Handpiece during tooth whitening procedures. The disposable shields fit over the head of the Handpiece and must be discarded after one-time use to avoid cross-contamination between patients.

BIOLASE, INC.

Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile
Primary Device ID00647529002711
NIH Device Record Key6047e460-4116-4c10-a52d-876ba2f2a150
Commercial Distribution StatusIn Commercial Distribution
Brand NameWhitening Handpiece Disposable Shields
Version Model Number6400180
Catalog Number6400180
Company DUNS152165700
Company NameBIOLASE, INC.
Device Count30
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100647529002704 [Unit of Use]
GS100647529002711 [Primary]

FDA Product Code

MMPCover, Barrier, Protective

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-26
Device Publish Date2018-09-25

Devices Manufactured by BIOLASE, INC.

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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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