FDA.reportPublic FDA data

Philips Sonicare

Primary DI
00075020063793
Brand
Philips Sonicare
Company
PHILIPS ORAL HEALTHCARE, LLC
Model
HX3211/23
Published
2020-05-14
Public version status
Update
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
00075020063793PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00075020063793000750200637930750200637930075020063793

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

Regulatory Flags#

DUNS number
608729869
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00075020072009Philips SonicareHX6062/902022-11-30
00075020072023Philips SonicareHX6062/922022-11-30
00075020072207Philips SonicareHX9023/922022-11-30
00075020106513Philips One BH1022/202022-10-12
00075020106544Philips OneHY1100/062022-10-12
00075020105691Philips SonicareHX9994/122022-09-01
00075020105011Philips SonicareHX3601/012022-08-16
00075020105028Philips SonicareHX9911/902022-06-28
00075020105035Philips SonicareHX9911/912022-06-28
00075020105042Philips SonicareHX9911/922022-06-28
00075020105059Philips SonicareHX9911/932022-06-28
00075020103857Philips oneHY1100/532022-05-20
00075020103864Philips OneHY1100/542022-05-20
00075020103475Philips SonicareHX6829/312022-04-08
00075020104038Philips SonicareHX6829/752022-04-08
00075020104700Philips SonicareHX9068/802022-04-08
00075020104717Philips SonicareHX9068/812022-04-08
00075020095664Philips SonicareHX9048/822022-04-07
00075020103772Philips SonicareHX6068/402022-04-07
00075020095657Philips SonicareHX6068/822022-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00100739503237WaterPik Sensonic Toothbrush Brush Heads (3pk)WATER PIK, INC.JEQ2026-03-03
05060640673342OrdoORDOCLUB LTDJEQ2026-02-06
05060640673359OrdoORDOCLUB LTDJEQ2026-02-06
05060640673366OrdoORDOCLUB LTDJEQ2026-02-06
05060640673403OrdoORDOCLUB LTDJEQ2026-02-06
05060640673472OrdoORDOCLUB LTDJEQ2026-02-06
10197344175871MEDLINEMEDLINE INDUSTRIES, INC.JEQ2026-01-22
10197344175888MEDLINEMEDLINE INDUSTRIES, INC.JEQ2026-01-22
00760236195696MeijerMEIJER, INC.JEQ2025-12-24
00760236195702MeijerMEIJER, INC.JEQ2025-12-24
00760236195719MeijerMEIJER, INC.JEQ2025-12-24
00760236195726MeijerMEIJER, INC.JEQ2025-12-24
00810126506146Joy by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCJEQ2025-12-16
00810131045319Ultim8 Adult Ortho Sonic Rechargeable Toothbrush Pearly White Supermouth LLCJEQ2025-12-02
00810131045326Ultim8 Adult Ortho Sonic Rechargeable Toothbrush Saphire BlueSupermouth LLCJEQ2025-12-02
00810131045333Ultim8 Adult Ortho Sonic Rechargeable Toothbrush Rose GoldSupermouth LLCJEQ2025-12-02
00817277020910UsmileGuangzhou Stars Pulse Co., Ltd.JEQ2025-11-17
00817277020965UsmileGuangzhou Stars Pulse Co., Ltd.JEQ2025-11-17
00817277020972UsmileGuangzhou Stars Pulse Co., Ltd.JEQ2025-11-17
00817277020989UsmileGuangzhou Stars Pulse Co., Ltd.JEQ2025-11-17
00817277021061UsmileGuangzhou Stars Pulse Co., Ltd.JEQ2025-11-17
00850078989109SmileSet Sonic Toothbrush Refill Heads - Black with MintOrtho Dental Lab LLCJEQ2025-09-25
00850078989116SmileSet Sonic Toothbrush Refill Heads - White with MintOrtho Dental Lab LLCJEQ2025-09-25
05060640672468OrdoORDOCLUB LTDJEQ2025-09-05
05060640672475OrdoORDOCLUB LTDJEQ2025-09-05
05060640672482OrdoORDOCLUB LTDJEQ2025-09-05
05060640672505OrdoORDOCLUB LTDJEQ2025-09-05
05060640672512OrdoORDOCLUB LTDJEQ2025-09-05
05060640672529OrdoORDOCLUB LTDJEQ2025-09-05
05060640672949OrdoORDOCLUB LTDJEQ2025-09-05