BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Waterpik Wizard Wedges

DI: D686613103 · Model: 061310-000 · WATER PIK, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

400

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Basic Information

Brand Name: Waterpik Wizard Wedges
Primary DI: D686613103
Version / Model: 061310-000
Catalog Number: 061310-000
Company Name: WATER PIK, INC.
Labeler DUNS: 001804074
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 400
Record Status: Published
Publish Date: 2020-08-31
Public Version: 3
Public Version Date: 2025-09-16
Public Version Status: Update
Public Device Record Key: 69f71745-5908-46b4-a382-52f2eea9e55c
Distribution End Date: 2025-09-15

Device Description

Anatomical wood matrix wedges, assortment of sizes - 100 ea - small, medium, large, and extra large

Device Characteristics

Single Use: Yes
Prescription Use (Rx): No
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: Yes
Has Serial Number: No
Has Lot/Batch Number: No
Has Manufacturing Date: No
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: Yes
Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DZN	Instruments, Dental Hand	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45007	Dental wedge, single-use	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D6860613100000	HIBCC
Primary	D686613103	HIBCC

Customer Contacts

Phone: (800) 525-2020
Email: [email protected]