FDA.reportPublic FDA data

OralKleen™

Primary DI
00850030081124
Brand
OralKleen™
Company
Oralkleen, LLC
Model
V1.2
Catalog number
715-0080
Device description
Electric Suctioning Toothbrush, 3.7V
Published
2025-10-22
Public version status
New
Distribution status
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
00850030081124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850030081124008500300811248500300811240850030081124

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.

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
00850030081056OralKleenV1.1615-01102024-09-12
00850030081063OralKleen™V1.1715-00762024-09-12
00850030081018OralKleenV1615-01002022-11-15
00850030081001OralKleenV1715-00202022-11-15
10850030081015OralKleenV1615-01002022-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192896123977Yankauer Pediatric Suction TubeSONTEC INSTRUMENTS, INC.JOL2026-10-27
06938320799707SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-23
06938320799714SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-23
06938320799738SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-23
06938320799745SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-23
00827002606616OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606623OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606630OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606647OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606654OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606661OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606678OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606685OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606692OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606708OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606715OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606722OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606739OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606746OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606753OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606760OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606777OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606784OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606791OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606807OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606814OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606821OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002613553CookCOOK INCORPORATEDJOL2026-10-22
04719965090020LED Operating LightCHUAN FU MEDICAL INSTRUMENT CO., LTD.EAZ2026-10-22
08033837933021CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13