FDA.reportPublic FDA data

Silk'n

Primary DI
17290112451672
Brand
Silk'n
Company
HOME SKINOVATIONS LTD
Model
ToothWave US
Catalog number
7290112451675
Device description
ToothWave™ is a powered radiofrequency toothbrush intended to promote good oral hygiene, including reduction of plaque and the prevention and treatment of gingivitis. ToothWave™ is intended for over-the-counter use.
Published
2021-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QMJPowered Radiofrequency Toothbrush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QMJPowered Radiofrequency ToothbrushDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN190039000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN190039000ToothWave™Home Skinovations , Ltd.2020-09-17QMJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290112451675Direct MarkingGS10
27290112451679PackageGS16In Commercial Distribution
17290112451672PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290112451675072901124516757290112451675
2729011245167927290112451679
1729011245167217290112451672

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency toothbrush An electrically-powered toothbrush, that additionally applies to dentition a radio-frequency (RF) alternating current, designed to be used to brush clean teeth and gums (i.e., remove plaque, tartar, stains). It consists of a proximal handle, and an exchangeable distal head with rows of bristles (e.g., nylon) and electrodes to generate the RF current into toothpaste and along dentition. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-877-367-4556contact@silkn.com

Regulatory Flags#

DUNS number
514891048
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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10075020040319PHILIPSLumea Comfort SC19810750200403122016-08-15
10866057000311SISLOYSupreme8660570003142017-06-18
17290015418468Silk'nFlash & Go Compact72900154184612016-08-15
17290015418512Silk'nGlide 150K Brazil72900154185152017-04-26
17290015418864Silk'nFlash & Go Express 72900154188672016-08-15
17290015763858Silk'nTitan72900157638512017-05-09
17290015764039Silk'nGlide Express Brazil 72900157640322017-04-26
17290015764527Silk'nBellaGlide72900157645202016-08-15
17290015764633Silk'nFaceFX 36072900157646362018-12-19
17290015764640Silk'nJewel72900157646432016-08-15
17290016627081Silk'nBellaFlash Pro72900166270842018-01-25
17290016627128Silk'nFlash & Go Pro72900166271212018-01-25
17290016627388Silk'nBellaGlide72900166273812017-07-12
17290016627852Silk'nFlash & Go LUXX72900166278552018-01-25
17290106259215PREMIER (AVOLOGI)Renelif72901062592182017-01-26
17290112450552Silk'nFlash & Go LUXX Mini-Spa72901124505552020-06-17
18712856055712Silk'nGlide87128560557152017-07-12
27290112450559Silk'nFlash & Go LUXX Mini-Spa72901124505552020-06-17
17290112452013Silk'n BellaVisage Hybrid72901124520162021-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290112451675Silk'n HOME SKINOVATIONS LTDQMJ2021-05-19