FDA.reportPublic FDA data

Waterpik Neo-Temp Temporary Cement

Primary DI
D686522003
Brand
Waterpik Neo-Temp Temporary Cement
Company
WATER PIK, INC.
Model
052200-000
Catalog number
052200-000
Device description
Temporary non-eugenol resin cement
Published
2016-07-29
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
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K884081000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K884081000INTERIM, TEMPORARY CEMENTScientific Pharmaceuticals, Inc.1988-12-02EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D686522003PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume15Milliliter
Weight1.5Gram
Weight10Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store away from sunlight.
Storage Environment Temperature32 Degrees Fahrenheit75 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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00073950333122Waterpik PowerPulseYCN-635EYCN-635E2024-03-15
00073950328258Waterpik PowerPulseYDT-933EYDT-933E2023-08-14
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