Waterpik Key-To Alginate Impression Material 013126-000

GUDID D6860131261

Heavy Body, Fast Set

WATER PIK, INC.

Alginate dental impression material
Primary Device IDD6860131261
NIH Device Record Key7d20d1b0-5441-4be9-82b4-3bc5d55fb660
Commercial Distribution Discontinuation2023-04-21
Commercial Distribution StatusNot in Commercial Distribution
Brand NameWaterpik Key-To Alginate Impression Material
Version Model Number013126-000
Catalog Number013126-000
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

Weight25 Pound
Weight25 Pound
Weight25 Pound
Weight25 Pound
Weight25 Pound
Weight25 Pound
Weight25 Pound
Weight25 Pound
Weight25 Pound
Weight25 Pound
Weight25 Pound
Weight25 Pound
Weight25 Pound
Weight25 Pound
Weight25 Pound
Weight25 Pound
Weight25 Pound
Weight25 Pound

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD6860131261 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELWMaterial, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2023-06-26
Device Publish Date2016-08-02

On-Brand Devices [Waterpik Key-To Alginate Impression Material]

D68601312612Alginate Impression Material, Heavy Body - Fast Set, 25lb (11.34kg) drum
D68601311396Alginate Impression Material, Regular Body - Fast Set, 1lb (454g) can
D68601311295Alginate Impression Material, Heavy Body - Fast Set, 1lb (454g) can
D68601311194Alginate Impression Material, Regular Body - Regular Set, 1lb (454g) can
D6860131261Heavy Body, Fast Set
D6860131139Regular Body, Fast Set
D6860131129Heavy Body, Fast Set
D6860131119Regular Body, Regular Set

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