FDA.report

Toothbrushes

Primary DI
00616784486239
Brand
Toothbrushes
Company
DYNAREX CORPORATION
Model
4862
Device description
Toothbrushes, Soft Nylon Bristles, 46 Tufts, Teal
Published
2021-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EFWToothbrush, Manual

Product Code Classifications

CodeDeviceSpecialtyClass
EFWToothbrush, ManualDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784486239PackageGS110In Commercial Distribution
00616784486222PrimaryGS10
00616784486215Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784486239006167844862396167844862390616784486239
00616784486222006167844862226167844862220616784486222
00616784486215006167844862156167844862150616784486215

GMDN Terms

TermDefinition
Basic manual toothbrushAn instrument designed to be used by a patient to manually brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device is typically used with toothpaste. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
144
DM exempt
false
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
true
Sterilization required before use
false

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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10889483563403BALLARD™SUNMED, LLCEFW2025-12-01
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10070942007419GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-08-15
20070942008093GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-08-15
10855424008487Freshen-UpMKJ Brands Limited Liability CompanyEFW2025-08-01
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06935883900021UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
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06935883900045UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
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