FDA.reportPublic FDA data

Philips Sonicare

Primary DI
00075020097323
Brand
Philips Sonicare
Company
PHILIPS ORAL HEALTHCARE, LLC
Model
HX9035/37
Published
2020-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
00075020071972PrimaryGS10
00075020077455PrimaryGS10
00075020097323Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00075020071972000750200719720750200719720075020071972
00075020077455000750200774550750200774550075020077455
00075020097323000750200973230750200973230075020097323

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
608729869
Device count
5
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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