FDA.reportPublic FDA data

Perio Sciences LED Tooth Whitener

Primary DI
00353238006208
Brand
Perio Sciences LED Tooth Whitener
Company
Perio Sciences, LLC
Model
10620
Device description
This device utilizes a tooth whitening tray which surrounds the teeth and holds a whitening formulation during the teeth whitening procedure. The whitening formulation is supplied in three single use pens. The device is fitted with blue and red LED lights to simultaneously help enhance the bleaching procedure and protect the gums and soft tissues.
Published
2024-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
EHYTray, Impression, Preformed
MAUEraser, Dental Stain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHYTray, Impression, PreformedDental1
MAUEraser, Dental StainDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00353238006208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00353238006208003532380062083532380062080353238006208

GMDN Terms#

Term, Definition table
TermDefinition
Teeth whitening kitA collection of devices intended to whiten natural teeth through bleaching. It typically includes a bleaching agent (e.g., a gel containing a low concentration of an oxidizing agent, such as carbamide peroxide or hydrogen peroxide), a syringe(s), a tray(s), a mouthguard, an applicator (e.g., a brush) and strips to apply/retain the bleaching agent to/on the teeth for a recommended period. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961798605
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00353238006109PerioSciences LED Electric Toothbrush106102024-02-08
00353238106113PerioSciences Replacement Electric Toothbrush Heads106112024-02-08
00353238106212Perio Sciences Replacement Tooth Whitening Pens106212024-02-08

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Primary DI, Brand, Company table
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