Waterpik Neo-Temp Temporary Cement 052200-000

GUDID D686522003

Temporary non-eugenol resin cement

WATER PIK, INC.

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin
Primary Device IDD686522003
NIH Device Record Keyf1fece42-3484-4506-9603-cf6737f4fd47
Commercial Distribution StatusIn Commercial Distribution
Brand NameWaterpik Neo-Temp Temporary Cement
Version Model Number052200-000
Catalog Number052200-000
Company DUNS001804074
Company NameWATER PIK, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
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

Device Dimensions

Weight10 Gram
Weight1.5 Gram
Total Volume15 Milliliter
Weight10 Gram
Weight1.5 Gram
Total Volume15 Milliliter
Weight10 Gram
Weight1.5 Gram
Total Volume15 Milliliter
Weight10 Gram
Weight1.5 Gram
Total Volume15 Milliliter
Weight10 Gram
Weight1.5 Gram
Total Volume15 Milliliter
Weight10 Gram
Weight1.5 Gram
Total Volume15 Milliliter
Weight10 Gram
Weight1.5 Gram
Total Volume15 Milliliter
Weight10 Gram
Weight1.5 Gram
Total Volume15 Milliliter
Weight10 Gram
Weight1.5 Gram
Total Volume15 Milliliter
Weight10 Gram
Weight1.5 Gram
Total Volume15 Milliliter
Weight10 Gram
Weight1.5 Gram
Total Volume15 Milliliter
Weight10 Gram
Weight1.5 Gram
Total Volume15 Milliliter
Weight10 Gram
Weight1.5 Gram
Total Volume15 Milliliter
Weight10 Gram
Weight1.5 Gram
Total Volume15 Milliliter
Weight10 Gram
Weight1.5 Gram
Total Volume15 Milliliter
Weight10 Gram
Weight1.5 Gram
Total Volume15 Milliliter
Weight10 Gram
Weight1.5 Gram
Total Volume15 Milliliter
Weight10 Gram
Weight1.5 Gram
Total Volume15 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from sunlight.
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from sunlight.
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from sunlight.
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from sunlight.
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from sunlight.
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from sunlight.
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from sunlight.
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from sunlight.
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from sunlight.
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from sunlight.
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from sunlight.
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from sunlight.
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from sunlight.
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from sunlight.
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from sunlight.
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from sunlight.
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from sunlight.
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD686522003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-06-13
Device Publish Date2016-07-29

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