FDA.reportPublic FDA data

Dentiguard

Primary DI
04061464611665
Brand
Dentiguard
Company
Aldi Inc.
Model
709476
Device description
LED Teeth Whitening Kit - Pen and Light
Published
2023-02-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EEGHeat Source For Bleaching Teeth
EHMStrip, Polishing Agent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EEGHeat Source For Bleaching TeethDental1
EHMStrip, Polishing AgentDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04061464611665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04061464611665040614646116654061464611665

GMDN Terms#

Term, Definition table
TermDefinition
Teeth whitening kitA collection of devices intended to whiten natural teeth through bleaching. It typically includes a bleaching agent (e.g., a gel containing a low concentration of an oxidizing agent, such as carbamide peroxide or hydrogen peroxide), a syringe(s), a tray(s), a mouthguard, an applicator (e.g., a brush) and strips to apply/retain the bleaching agent to/on the teeth for a recommended period. This is a reusable device.

Regulatory Flags#

DUNS number
006940423
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04061464695061Visage7097212023-07-12
04061464695078Visage7097212023-07-12
04061464695085Visage7097212023-07-12
04061464695160Visage7097212023-07-12
04061464695177Visage7097212023-07-12
04061464695184Visage7097212023-07-12
04099100312362ViSAGE7000662022-03-10
04099100312379ViSAGE7000662022-03-10
04099100312386ViSAGE7000662022-03-10
04099100312393ViSAGE7000662022-03-10
04099100312409ViSAGE7000662022-03-10
04099100312447ViSAGE7000662022-03-10
04099100312454ViSAGE7000662022-03-10
04099100312461ViSAGE7000662022-03-10
04099100312478ViSAGE7000662022-03-10
04099100312485ViSAGE7000662022-03-10
04099100312492ViSAGE7000662022-03-10
04099100312508ViSAGE7000662022-03-10
04061463669100VISAGE517982022-09-21
04061463669223VISAGE517982022-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ESUN3048Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46708Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46718Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46728Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46738Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46748Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46768Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46778Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46808Jiffy proximal sawDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46838Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3541008Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF354L8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF354LD8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3568Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF356L8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3638Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3648Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3668Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF37258Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3725BULK5008Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3725LW8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3738Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF373D8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3748Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF374BULK5008Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF374D8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF374LW8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3768Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF376D8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNG30450MM8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30