FDA.reportPublic FDA data

Rotadent

Primary DI
D81394000WTYH0
Brand
Rotadent
Company
DEN-MAT HOLDINGS, LLC
Model
94000WTYH
Catalog number
94000WTYH
Device description
RD PROCARE WTY HANDLE
Published
2025-02-19
Public version status
New
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
D81394000WTYH0PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
1-800-433-6628INFO@DENMAT.COM

Regulatory Flags#

DUNS number
809857704
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D8130303761050GBLOCK0303761052023-03-06
D8130303761100GBLOCK0303761102023-03-06
00359883007218EVANESCE0322200322202025-10-08
00359883005214Max Etch 35% Phosphoric Acid Etch 30mL3453023453022025-03-12
00359883005221Max Etch 35% Phosphoric Acid Etch 5mL3455033455032025-03-12
D8130301255000Ceri-Prime0301255000301255002016-09-24
D8130304025501Cerinate®0304025500304025502016-09-24
D8131002AB0Ceri-Prime1002AB1002AB2016-09-24
D8131398B0Ceri-Prime1398B1398B2016-09-24
D81313990Ceri-Prime139913992016-09-24
D813402022B0Other402022B402022B2016-09-24
D8134020600Ceri-Prime4020604020602016-09-24
D81340213100Ceri-Prime402131040213102016-09-24
00359883007201EVANESCE0322550322552025-05-30
00359883005665Tissue Goo™ Hemostatic Gel 4-Pack6419046419042025-03-18
00359883005672Tissue Goo™ Hemostatic Gel Big Shot Syringe Kit6419606419602025-03-18
00359883002053Affinity™ Heavy Body RS 120ml 2-Pack0234010234012025-03-14
00359883002046Affinity™ Heavy Body RS 120ml 2-Pack0234010234012025-03-14
00359883006273Final Shine Cotton Polishing Wheel 50-Pack1335001335002025-03-13
00359883006501Clinician's Choice® G5 Sample Pack9726059726052025-03-13

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