FDA.reportPublic FDA data

Waterpik Getz Blue Core

Primary DI
D686414183
Brand
Waterpik Getz Blue Core
Company
WATER PIK, INC.
Model
041418-000
Catalog number
041418-000
Device description
Light-cured crown build-up material
Published
2016-07-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K832781000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K832781000CURAY-SUPPORT, CORE BUILD-UP MATERIALScientific Pharmaceuticals, Inc.1983-10-19EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D686414183PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis restorative material, unfilled resinA material designed to repair dental prostheses that consists of an unfilled polymeric resin. The material works as a bonding agent to provide a strong and long-lasting attachment to the segments of a broken or cracked prosthesis; it typically consists of a single or two-component polymeric (e.g., acrylic) resin that usually becomes a solid polymer when treated with light and/or heat. The material is used in a dentist?s office or dental laboratory to repair fixed dental prostheses and/or partial or total dentures.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight5Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store away from sunlight
Storage Environment Temperature68 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 525-2020professional@waterpik.com

Regulatory Flags#

DUNS number
001804074
Device count
1
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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00073950345897Waterpik Cordless Enhance 3200 Water Flosser20034589WF-34W010(S)2026-05-26
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00073950339322WaterPik Caddy Buddy with PowerPulsePHO-559MEPHO-559ME2025-01-29
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00073950333689Waterpik PowerPulse with DualDockQMR-863MEQMR-863ME2024-04-29
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