FDA.reportPublic FDA data

Waterpik Wizard Wedges

Primary DI
D6860613080000
Brand
Waterpik Wizard Wedges
Company
WATER PIK, INC.
Model
061308-000
Catalog number
061308-000
Device description
Anatomical wood matrix wedges, large (purple)
Published
2020-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
D686613083PrimaryHIBCC0
D6860613080000Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental wedge, single-useA dental device that is positioned wedge-like at the interdental and cervical area of the teeth during routine intraoral dental procedures. It is used to slightly separate the teeth during the placement of a filling material, or to stabilize and support other devices, e.g., a matrix band or a rubber dam. 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
400
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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Primary DI, Brand, Model table
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