FDA.reportPublic FDA data

PerioSciences LED Electric Toothbrush

Primary DI
00353238006109
Brand
PerioSciences LED Electric Toothbrush
Company
Perio Sciences, LLC
Model
10610
Device description
An electrically powered device designed to be used by a patient-consumer to brush clean their teeth and gums (i.e., to remove plaque, tartar and stains). It comprises a proximal handle and an exchangeable distal head with rows of bristles group in separate tufts. The device provides automated vibratory bristle movement intended to augment brushing. The brush also provides a blue and red LED light to help clean the teeth, stimulate soft tissue, and promote overall oral health. The brush is typically used with toothpaste.
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
JEQToothbrush, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEQToothbrush, PoweredDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00353238006109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00353238006109003532380061093532380061090353238006109

GMDN Terms#

Term, Definition table
TermDefinition
Basic electric toothbrushAn electrically-powered device designed to be used by a patient to brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and an exchangeable distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device provides automated bristle movement (e.g., rotary or vibratory) intended to augment brushing, and is typically used with toothpaste. 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
00353238006208Perio Sciences LED Tooth Whitener106202024-02-08
00353238106113PerioSciences Replacement Electric Toothbrush Heads106112024-02-08
00353238106212Perio Sciences Replacement Tooth Whitening Pens106212024-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00073950323734WaterPik Sensonic Toothbrush Brush Heads (3pk)WATER PIK, INC.JEQ2026-03-03
00197344175874MEDLINEMEDLINE INDUSTRIES, INC.JEQ2026-01-22
00197344175881MEDLINEMEDLINE INDUSTRIES, INC.JEQ2026-01-22
00817277021054UsmileGuangzhou Stars Pulse Co., Ltd.JEQ2025-10-05
00194346288038EQUATEWAL-MART STORES, INC.JEQ2024-11-15
00032251933578Family WellnessFamily Dollar StoresJEQ2024-04-09
00073950330046Waterpik Sensonic Complete CareWATER PIK, INC.JEQ2024-02-13
10810063755321OralPro Electric Toothbrush Replacement HeadSAFCO DENTAL SUPPLY CO.JEQ2023-08-14
10810063755345OralPro Ultra Sensitive Electric Toothbrush Replacement HeadSAFCO DENTAL SUPPLY CO.JEQ2023-08-14
10810063755352SonicPro Electric Toothbrush Replacement HeadSAFCO DENTAL SUPPLY CO.JEQ2023-08-14
10810063755376SonicPro Compact Electric Toothbrush Replacement HeadSAFCO DENTAL SUPPLY CO.JEQ2023-08-14
10810063755383SonicPro Ultra Sensitive Electric Toothbrush Replacement HeadSAFCO DENTAL SUPPLY CO.JEQ2023-08-14
00194346119691Equate Essential Clean Replacement Toothbrush Brush HeadsWAL-MART STORES, INC.JEQ2023-07-10
00194346119707Equate Advanced Clean Replacement Toothbrush Brush HeadsWAL-MART STORES, INC.JEQ2023-07-10
00723896001936Smilegoods Sonic Toothbrush BlackPRACTICON, INC.JEQ2023-06-09
00723896018729Smilegoods Sonic Toothbrush White PRACTICON, INC.JEQ2023-06-09
00723896018743Smilegoods Sonic Toothbrush PinkPRACTICON, INC.JEQ2023-06-09
00073950324779Waterpik Cordless Pearl Water Flosser and Sensonic ToothbrushWATER PIK, INC.JEQ2023-06-02
00810051084313Gurunanda Ultimate Oral Care ComboGurunanda, LLCJEQ2023-05-31
00810051083637Sonic Vibration Expert Clean Toothbrush - 2 PackGurunanda, LLCJEQ2023-04-27
00073950314596Waterpik Complete Care SensonicWATER PIK, INC.JEQ2023-04-13
00073950314572Waterpik Complete Care SensonicWATER PIK, INC.JEQ2023-04-12
00070942122542GUM®SUNSTAR AMERICAS, INC.JEQ2023-02-28
00070942122559GUM®SUNSTAR AMERICAS, INC.JEQ2023-02-28
00817169023067Joy by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCJEQ2023-01-11
00817169023074Joy by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCJEQ2023-01-11
00817169023081Joy by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCJEQ2023-01-11
00075020072009Philips SonicarePHILIPS ORAL HEALTHCARE, LLCJEQ2022-11-30
00075020072023Philips SonicarePHILIPS ORAL HEALTHCARE, LLCJEQ2022-11-30
00075020072207Philips SonicarePHILIPS ORAL HEALTHCARE, LLCJEQ2022-11-30