Waterpik Kalginate Alginate Impression Material 015021-000

GUDID D6860150219

Regular Set

WATER PIK, INC.

Alginate dental impression material
Primary Device IDD6860150219
NIH Device Record Keyf7c67860-a6d8-4830-ae21-b2adcb8f22da
Commercial Distribution StatusIn Commercial Distribution
Brand NameWaterpik Kalginate Alginate Impression Material
Version Model Number015021-000
Catalog Number015021-000
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

Weight1 Pound
Weight1 Pound
Weight1 Pound
Weight1 Pound
Weight1 Pound
Weight1 Pound
Weight1 Pound
Weight1 Pound
Weight1 Pound
Weight1 Pound
Weight1 Pound
Weight1 Pound
Weight1 Pound
Weight1 Pound
Weight1 Pound
Weight1 Pound
Weight1 Pound
Weight1 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
HIBCCD6860150219 [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 Number4
Public Version Date2023-06-26
Device Publish Date2016-08-02

On-Brand Devices [Waterpik Kalginate Alginate Impression Material]

D68601502398Alginate Impression Material, Fast Set, 1lb (454g) can
D68601502196Alginate Impression Material, Regular Set, 1lb (454g) can
D6860150239Fast Set
D6860150219Regular Set

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