FDA.reportPublic FDA data

OralKleen

Primary DI
00850030081001
Brand
OralKleen
Company
Oralkleen, LLC
Model
V1
Catalog number
715-0020
Device description
Electric Suctioning Toothbrush
Published
2022-11-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EAZLight, Operating, Dental
JEQToothbrush, Powered
JOLCatheter And Tip, Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAZLight, Operating, DentalDental1
JEQToothbrush, PoweredDental1
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850030081001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850030081001008500300810018500300810010850030081001

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
602-767-2422contact@oralkleen.com

Regulatory Flags#

DUNS number
122347960
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850030081124OralKleen™V1.2715-00802025-10-22
00850030081056OralKleenV1.1615-01102024-09-12
00850030081063OralKleen™V1.1715-00762024-09-12
00850030081018OralKleenV1615-01002022-11-15
10850030081015OralKleenV1615-01002022-11-15

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