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Perio Sciences Replacement Tooth Whitening Pens

Primary DI
00353238106212
Brand
Perio Sciences Replacement Tooth Whitening Pens
Company
Perio Sciences, LLC
Model
10621
Device description
Replacement pens for the Perio Sciences LED Tooth Whitener Device. The composition is used in the whitening tray which encloses the teeth during the whitening procedure.
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
MAUEraser, Dental Stain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAUEraser, Dental StainDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00353238106212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00353238106212003532381062123532381062120353238106212

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
00353238006208Perio Sciences LED Tooth Whitener106202024-02-08
00353238106113PerioSciences Replacement Electric Toothbrush Heads106112024-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860012825516SmileDirectClub Whitening Pen - 9 Pack Plus LightOrtho Dental Lab LLCMAU2025-10-16
00860012825523SmileDirectClub Dissolving StripsOrtho Dental Lab LLCMAU2025-10-16
00860012825530SmileDirectClub Whitening Pen - 4 Pack Plus LightOrtho Dental Lab LLCMAU2025-10-16
00860012825547SmileDirectClub Whitening Refill - 8 PackOrtho Dental Lab LLCMAU2025-10-16
00860012825561SmileDirectClub Whitening plus Lip Balm - 4 PackOrtho Dental Lab LLCMAU2025-10-16
00850078989123SmileSet Premium Whitening Kit – BlackOrtho Dental Lab LLCMAU2025-09-25
00850078989130SmileSet Premium Whitening Kit – MintOrtho Dental Lab LLCMAU2025-09-25
00850078989147SmileSet Premium Whitening Kit – WhiteOrtho Dental Lab LLCMAU2025-09-25
00850078989154SmileSet Premium Whitening Refill – 4 PackOrtho Dental Lab LLCMAU2025-09-25
00850078989161SmileSet Premium Whitening Sample Pen – 3 mlOrtho Dental Lab LLCMAU2025-09-25
00850078989178SmileSet Premium Sensitive Whitening StripsOrtho Dental Lab LLCMAU2025-09-25
00353238006208Perio Sciences LED Tooth WhitenerPerio Sciences, LLCMAU2024-02-08
06970016621824NonJiangxi Dentalbright Technology Co., LtdMAU2023-05-06
07506338301480MDC DentalMDC DENTALMAU2023-05-04
06970016623651DanielJiangxi Dentalbright Technology Co., LtdMAU2023-03-25
06970016621404GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016621534GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016621831GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016621879GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016622005GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016622807GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016622920GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016623057GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016623200GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016623293GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016624030GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016624481GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016624887GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016625006GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016625891GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22