FDA.reportPublic FDA data

Electric Toothbrush

Primary DI
00850007728069
Brand
Electric Toothbrush
Company
Access Dental Lab, LLC
Model
100-0357
Device description
Power toothbrush-Blurple-ECOMM
Published
2019-08-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
00850007728069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850007728069008500077280698500077280690850007728069

GMDN Terms#

Term, Definition table
TermDefinition
Basic electric toothbrush, battery-poweredA battery-powered instrument designed to be used by a person to brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and distal head to which is attached two or more rows of bristles (e.g., nylon) grouped in separate tufts, in rows, or evenly distributed. The device provides automated bristle movement (e.g., rotary or vibratory) intended to augment brushing, and is typically used with toothpaste; it is normally available [non-prescription] over-the-counter (OTC). The toothbrush head may be exchangeable. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
901-361-0576joe.miller@accessdentallab.com

Regulatory Flags#

DUNS number
054012763
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850007728427SmileDirectClub Retainer 140-00042023-11-30
00850007728410ALIGNER SEATER PURPLE220-00052023-02-17
00850007728243SDC impression material (Zest)200-01062023-02-17
00850007728250SDC-impression material (Kulzer)200-01072023-02-17
00850007728342Smile stretcher-purple bag200-00492023-02-17
00850007728366Impression Tray XSM200-00112023-02-17
00850007728373IMPRESSION TRAY SM200-00122023-02-17
00850007728380IMPRESSION TRAY MED200-00132023-02-17
00850007728397IMPRESSION TRAY LRG200-00142023-02-17
00850007728403IMPRESSION TRAY XLG200-00152023-02-17
00850007728274SDC ALIGNERS MCC100-00102022-12-09
00850007728281SDC Aligners-REF100-00122022-12-09
00850007728298SDC Aligners-REP100-03552022-12-09
00850007728304NIGHTTIME CLEAR ALIGNERS100-03622022-12-09
00850007728311NIGHTTIME ALIGNERS-MCC100-03632022-12-09
00850007728328NIGHTTIME ALIGNERS - REF100-03642022-12-09
00850007728335NIGHTTIME -REP100-03652022-12-09
00850007728267SDC Aligners-100-03522022-12-07
00850007728052electric toothbrush100-03562019-08-14
00850007728076ElectricToothbrush100-03582019-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06938320799899SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799905SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799912SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799929SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799936SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799943SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799950SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799967SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799981SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799998SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
05060640673731OrdoORDOCLUB LTDJEQ2026-09-22
05060640673748OrdoORDOCLUB LTDJEQ2026-09-22
05060640674097OrdoORDOCLUB LTDJEQ2026-09-22
05060640674141OrdoORDOCLUB LTDJEQ2026-09-22
05060640674486OrdoORDOCLUB LTDJEQ2026-09-22
00072239332290Dr. Brown'sDr. Brown's CompanyJEQ2026-06-05
00072239332511Dr. Brown'sDr. Brown's CompanyJEQ2026-06-05
00072239332528Dr. Brown'sDr. Brown's CompanyJEQ2026-06-05
05060640673717OrdoORDOCLUB LTDJEQ2026-05-29
05060640673830OrdoORDOCLUB LTDJEQ2026-05-29
05060640673953OrdoORDOCLUB LTDJEQ2026-05-29
05060640673960OrdoORDOCLUB LTDJEQ2026-05-29
05060640673991OrdoORDOCLUB LTDJEQ2026-05-29
05060640674004OrdoORDOCLUB LTDJEQ2026-05-29
05060640674011OrdoORDOCLUB LTDJEQ2026-05-29
05060640674035OrdoORDOCLUB LTDJEQ2026-05-29
00073950323734WaterPik Sensonic Toothbrush Brush Heads (3pk)WATER PIK, INC.JEQ2026-03-03
00197344175874MEDLINEMEDLINE INDUSTRIES, INC.JEQ2026-01-22
00197344175881MEDLINEMEDLINE INDUSTRIES, INC.JEQ2026-01-22
00194346288038EQUATEWAL-MART STORES, INC.JEQ2024-11-15