FDA.reportPublic FDA data

PerioSciences Replacement Electric Toothbrush Heads

Primary DI
00353238106113
Brand
PerioSciences Replacement Electric Toothbrush Heads
Company
Perio Sciences, LLC
Model
10611
Device description
Replacement toothbrush heads for PerioSciences LED electric toothbrush
Published
2024-02-08
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
00353238106113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00353238106113003532381061133532381061130353238106113

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
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
00353238006109PerioSciences LED Electric Toothbrush106102024-02-08
00353238006208Perio Sciences LED Tooth Whitener106202024-02-08
00353238106212Perio Sciences Replacement Tooth Whitening Pens106212024-02-08

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