FDA.reportPublic FDA data

Waterpik Getz Blue Core

Primary DI
D6864141839
Brand
Waterpik Getz Blue Core
Company
WATER PIK, INC.
Model
041418-000
Catalog number
041418-000
Device description
Crown build-up material, single 5 g syringe
Published
2016-07-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
D6864141839PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
001804074
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00073950341295Waterpik Cordless Pearl Water Flosser20034561WF-31CD0102026-06-09
00073950345927Waterpik Cordless Enhance 3200 Water Flosser20034592WF-34W012(S)2026-06-09
00073950346788Waterpik Cordless Pulse 3100 Water Flosser20034678WF-20CD0152026-05-26
00073950345897Waterpik Cordless Enhance 3200 Water Flosser20034589WF-34W010(S)2026-05-26
00073950346122Waterpik Cordless Water Flosser20034612WF-35W017(S)2026-05-26
00073950347167Waterpik Cordless 1200 Water Flosser20034616WF-36W011(S)2026-05-26
10056310971209Water Pik Revive with PowerPulse20034197-120CURV-563M2025-04-09
00073950337885WaterPik Transform RV with PowerPulsePHR-553EPHR-553E2025-01-29
00073950337960WaterPik Transform RV with PowerPulsePHR-559EPHR-559E2025-01-29
00073950338011WaterPik Transform RV with PowerPulsePHR-551EPHR-551E2025-01-29
00073950339230WaterPik Caddy Buddy with PowerPulsePHO-553MEPHO-553ME2025-01-29
00073950339322WaterPik Caddy Buddy with PowerPulsePHO-559MEPHO-559ME2025-01-29
00073950339346WaterPik Caddy Buddy with PowerPulsePHO-555EPHO-555E2025-01-29
00073950333689Waterpik PowerPulse with DualDockQMR-863MEQMR-863ME2024-04-29
00073950333726Waterpik PowerPulse with DualDockQMR-869MEQMR-869ME2024-04-29
00073950333924Waterpik RainFall+ with PowerPulse YPW-833EYPW-833E2024-04-29
00073950334303Waterpik PowerPulseXSP-755MEXSP-755ME2024-04-29
00073950333184Waterpik PowerPulseXFT-763MEXFT-763ME2024-04-02
00073950332996Waterpik RainFall+ with PowerPulse XED-633EXED-633E2024-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00810222900053Midas Restore - C2 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544610Midas Restore - A1 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544627Midas Restore - A2 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544634Midas Restore - A3 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544641Midas Restore - B1 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544658Midas Restore - Bleach - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544665Midas Restore - Unpigmented - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544672Midas Restore - A1 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544689Midas Restore - A2 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544696Midas Restore - A3 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544702Midas Restore - B1 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544719Midas Restore - Bleach - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544726Midas Restore - Unpigmented- Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
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