FDA.reportPublic FDA data

Waterpik Key-To Alginate Impression Material

Primary DI
D6860131139
Brand
Waterpik Key-To Alginate Impression Material
Company
WATER PIK, INC.
Model
013113-000
Catalog number
013113-000
Device description
Regular Body, Fast Set
Published
2016-08-02
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
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970594000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970594000KALGINATE IMPRESSION MATERIALTeledyne Water Pik1997-03-31ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D6860131139PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Alginate dental impression materialA material containing alginate as an essential gel-forming ingredient, which, after mixing with water, reaches a consistency suitable for taking impressions of a patient's teeth and gums, or other oral anatomy. The material is placed on an impression tray and inserted into the mouth. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight1Pound

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

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

Other Devices From This Company#

Primary DI, Brand, Model table
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00073950346122Waterpik Cordless Water Flosser20034612WF-35W017(S)2026-05-26
00073950347167Waterpik Cordless 1200 Water Flosser20034616WF-36W011(S)2026-05-26
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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
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00073950333924Waterpik RainFall+ with PowerPulse YPW-833EYPW-833E2024-04-29
00073950334303Waterpik PowerPulseXSP-755MEXSP-755ME2024-04-29
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00073950332996Waterpik RainFall+ with PowerPulse XED-633EXED-633E2024-03-15

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