Waterpik Opotow Trial Cement 052120-000

GUDID D686521203

Non-hardening zinc oxide eugenol temporary dental cement

WATER PIK, INC.

Zinc oxide eugenol dental cement
Primary Device IDD686521203
NIH Device Record Key63b4ae1b-a582-4dbc-840f-9f0f407d0e7a
Commercial Distribution StatusIn Commercial Distribution
Brand NameWaterpik Opotow Trial Cement
Version Model Number052120-000
Catalog Number052120-000
Company DUNS001804074
Company NameWATER PIK, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com

Device Dimensions

Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram
Weight10 Gram
Weight38 Gram

Operating and Storage Conditions

Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD686521203 [Primary]

FDA Product Code

EMBZinc Oxide Eugenol

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-08
Device Publish Date2020-08-31

Devices Manufactured by WATER PIK, INC.

00073950335232 - Water Pik Ultra Plus Waterflosser2025-07-10 Countertop Waterflosser
00073950335454 - WaterPik Ultra Water Flosser2025-07-10 Countertop Waterflosser, Black
00073950335485 - WaterPik Ultra Water Flosser2025-07-10 Countertop Waterflosser, Black
10073950342886 - WaterPik Ultra Combo Pack2025-06-26 1 Countertop Water Flosser (White), 1 Countertop Water Flosser (Black)
00073950337151 - Waterpik Cordless 1000 Water Flosser2025-06-23 Cordless Handheld Water Flosser, White
00073950338059 - WaterPik Cordless Plus 5000 Water Flosser2025-06-17 Cordless Handheld Water Flosser - White
00073950338103 - WaterPik Cordless Plus 5000 Water Flosser2025-06-17 Cordless Handheld Water Flosser - Black
10056310971209 - Water Pik Revive with PowerPulse2025-04-17 Handheld Pivoting Showerhead, Chrome Finish

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.