FDA.reportPublic FDA data

"Smile Sidekick Replacement Head Nylon Dr. H.O.S.S ""S"" Bristles"

Primary DI
00810131040468
Brand
"Smile Sidekick Replacement Head Nylon Dr. H.O.S.S ""S"" Bristles"
Company
Supermouth LLC
Model
38000015
Device description
Replacement Brush Head
Published
2024-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00810131040468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810131040468008101310404688101310404680810131040468

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
049384038
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810131045319Ultim8 Adult Ortho Sonic Rechargeable Toothbrush Pearly White 40000222025-12-02
00810131045326Ultim8 Adult Ortho Sonic Rechargeable Toothbrush Saphire Blue40000232025-12-02
00810131045333Ultim8 Adult Ortho Sonic Rechargeable Toothbrush Rose Gold40000242025-12-02
00810131044190Ultim8 Adult Rose Gold Sonic Rechargeable Toothbrush40000172025-06-30
00810131044725Adult SuperScraper Silver100000072025-06-30
00810131044732Adult SuperScraper Rose Gold100000082025-06-30
00850036799993Ultim8 Sonic Pearly White Toothbrush & UV Sanitizer Box Set 120000262025-06-30
00810131041502Adult Resuable Tongue Scraper 100000032025-05-25
00810131041519Ortho Resuable Tongue Scraper Silver100000042025-05-25
00810131041526Ortho Resuable Tongue Scraper Rose Gold100000052025-05-25
00810131040000Super Vanilla Ortho Floss Fluoride07002020562024-06-01
00810131040017Super StrawberryOrtho Floss Fluoride07002040562024-06-01
00810131040024Super Mint Ortho Floss Fluoride07002050562024-06-01
00810131040031Super Chocolate Ortho Floss Fluoride07002030562024-06-01
00810131040215Superbrush Bluetooth Brush Junior040000012024-06-01
00810131040222Superbrush Orange A Peel Brush Junior040000022024-06-01
00810131040239Superbrush Yellow Sunshine Brush Junior040000032024-06-01
00810131040246Superbrush Tangerine Clean Toothbrush040000042024-06-01
00810131040253Superbrush Breath Mint Toothbrush040000052024-06-01
00810131040260Superbrush Blue Biome Toothbrush040000062024-06-01

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