FDA.reportPublic FDA data

Waterpik Wizard Wedges

Primary DI
D6860612110003
Brand
Waterpik Wizard Wedges
Company
WATER PIK, INC.
Model
061211-000
Catalog number
061211-000
Device description
Wood matrix wedges, small
Published
2020-08-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZNInstruments, Dental Hand

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D6860612110003PrimaryHIBCC0
D6860612110000Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental wedge, single-useA small, dental device intended to be introduced between two adjacent teeth for slight separation during a dental procedure. It is typically used during the placement of a filling material, or to stabilize and support other devices (e.g., a matrix band and/or rubber dam). It may include a removable shield intended to protect the healthy tooth/teeth from damage by the instruments. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(800) 525-2020professional@waterpik.com

Regulatory Flags#

DUNS number
001804074
Device count
500
Premarket exempt
true
Sterilization required before use
true

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Primary DI, Brand, Model table
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Primary DI, Brand, Company table
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