BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Waterpik Opotow Standard Z.O.E. Impression Paste

DI: D686122003 · Model: 012200-000 · WATER PIK, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: Waterpik Opotow Standard Z.O.E. Impression Paste
Primary DI: D686122003
Version / Model: 012200-000
Catalog Number: 012200-000
Company Name: WATER PIK, INC.
Labeler DUNS: 001804074
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
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: 00bbeeca-425a-4fa3-9c21-c2d25e75f18a
Distribution End Date: 2025-09-15

Device Description

Zinc oxide eugenol impression paste, Type I heavy-bodied

Device Characteristics

Single Use: No
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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EMB	Zinc Oxide Eugenol	Dental	872.3275	1

GMDN Terms

Code	Name	Definition	Implantable	Status
17844	Dental articulation paste/solution	A substance intended to characterize the contact relationship between the maxillary and the mandibular teeth during occlusion, and between interproximal surfaces, to help determine the proper seating of full or partial dentures, crowns and bridges, and to program and/or assess progress of orthodontic treatment. It may include one or more substances (e.g., wetting spray, silicone paste, drying liquid that turns into a removable film) and is designed to be applied to the teeth or a restorative prosthesis to show the contact surfaces in situ or on a substrate (e.g., impression material) that displays visible marks when the patient bites. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D686122003	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Weight	80	Gram
Weight	145	Gram

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: 68 – 77 Degrees Fahrenheit