FDA.reportPublic FDA data

Toothbrushes

Primary DI
00616784486123
Brand
Toothbrushes
Company
DYNAREX CORPORATION
Model
4861
Device description
Toothbrushes, Adult, 30 Tuft, Ivory
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

Product Codes#

Code, Name table
CodeName
EFWToothbrush, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFWToothbrush, ManualDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784486123PackageGS16In Commercial Distribution
00616784486130PackageGS110In Commercial Distribution
00616784486116PrimaryGS10
00616784486109Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784486123006167844861236167844861230616784486123
00616784486130006167844861306167844861300616784486130
00616784486116006167844861166167844861160616784486116
00616784486109006167844861096167844861090616784486109

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
008124539
Device count
24
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00616784709734Blood Pressure Cuff Kits, Sphygmomanometer, 3-Cuffs, Child, Adult, Large Adult70972017-11-21
00616784710327Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71032016-09-24
00616784710518Sphygmomanometer71052016-09-24
00616784710617Sphygmomanometer71062016-09-24
00616784711027Single Head Stethoscope, Single Head71102021-04-22
00616784711126Stethoscope Dual Head71112021-04-22
00616784711225PA SensiLance Pressure Activated Safety Lancets, Sterile71122021-05-21
00616784711423PA [SensiLance Pressure Activated Safety Lancets,Sterile71142021-05-21
00616784709833Blood Pressure Cuff Kits, Sphygmomanometer, 5-Cuffs, Infant, Child, Adult, Large70982017-11-21
00616784709529Digital Blood Pressure Monitor70952021-01-19
00616784709628Digital Blood Monitors70962021-01-19
00616784709925Blood Pressure Kit,Sphymomanometer with Dual Head Stethoscope70992016-09-24
00616784710020Blood Pressure Kit Sphygmomanometer with Stethoscope71002016-09-24
00616784710228Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71022016-09-24
00840117344761Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310612026-05-25
00840117344778Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310622026-05-25
00840117346215Resp-O2 Closed Suction Endotracheal Catheter, 10 FR (3.3 mm)310632026-05-25
00840117349711IV Extension Sets Needle-Free Luer Lock Connector For Injection, Non-Toxic, 17"70612016-09-24
00840117349742IV Extension Sets Needle-Free Luer Lock Connector, Non-Toxic, 8" (20.3 cm)70622016-09-24
00616784706313IV Extension Sets Needle-Free Luer Lock Connector for Injection Non-Toxic70632024-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817169029892Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEFW2026-03-05
00810126504371Dream by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEFW2025-12-16
10884392008427Safety 1stDOREL JUVENILE GROUP, INC.EFW2025-12-15
10889483563403BALLARD™SUNMED, LLCEFW2025-12-01
10070942007365GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-08-15
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
00304040192474Henry ScheinHENRY SCHEIN, INC.EFW2025-07-08
00194346458844EquateWAL-MART STORES, INC.EFW2025-07-07
06935883900014UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
06935883900021UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
06935883900038UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
06935883900045UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
06935883900052UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
06935883900069UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
06935883900076UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
06935883900083UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
06935883900090UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
06935883900106UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
00810180842044DynaCare Kids, Kids Toothbrushes, Assorted Colors, Soft Nylon Bristles Dynarex CorporationEFW2025-06-02
00072239331057Dr. Brown'sDr. Brown's CompanyEFW2025-05-23
00072239330418Dr. Brown'sDr. Brown's CompanyEFW2025-05-22
20070942006372GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-05-19
20070942008109GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-05-19
20070942008116GUM Technique Deep CleanSUNSTAR AMERICAS, INC.EFW2025-05-19
20810063756240KIDS BUDDY ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
20810063756257Power Curve ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
20810063756264Esprit Ultra Fine ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
20810063756271Whisper Tech Ultra-Fine ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19