FDA.report

Philips Sonicare

Primary DI
00075020031891
Brand
Philips Sonicare
Company
PHILIPS ORAL HEALTHCARE, LLC
Model
HX3013/64
Published
2020-08-21
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

Related Records

Product Codes

CodeName
JEQTOOTHBRUSH, POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
JEQToothbrush, PoweredDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00075020031891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00075020031891000750200318910750200318910075020031891

GMDN Terms

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

Regulatory Flags

DUNS number
608729869
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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 DIBrandModelCatalogPublished
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
00075020104106Philips SonicareHX6462/712022-04-06
00075020104113Philips SonicareHX6422/862022-04-06
00075020104205Philips SonicareHX9913/712022-04-06
00075020104212Philips SonicareHX9913/722022-04-06
00075020104229Philips SonicareHX9913/812022-04-06
00075020104236Philips SonicareHX9913/822022-04-06

Other Devices Sharing Product Codes

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