FDA.reportPublic FDA data

TEETH WHITENING KIT

Primary DI
00681131430333
Brand
TEETH WHITENING KIT
Company
Gurunanda, LLC
Model
IVUL-06W-V1
Device description
LED WHITENING ACCELERATOR LIGHT + WHITENING PENS
Published
2023-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
EEGHeat Source For Bleaching Teeth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EEGHeat Source For Bleaching TeethDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00681131430333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00681131430333006811314303336811314303330681131430333

GMDN Terms#

Term, Definition table
TermDefinition
Tooth-bleaching acceleration unitA heat and/or light source intended to increase the oxidative effect of tooth bleachers (e.g., oxygen peroxide, carbamide peroxide, hydrogen peroxide) during tooth whitening dental procedures. It typically consists of a dedicated electromagnetic energy source (e.g., xenon lamp, LED), which may operate within a specific wavelength range, a laser, or an electric powered heater. The device is typically used during procedures in dental offices.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079671169
Device count
1
Premarket exempt
true
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00810051089004GuruNandaGNF1352026-01-28
00810051089479GuruNandaGNF1352026-01-28
00810051089530GuruNanda Ultrasonic Aligner Cleaning PodGN089532025-08-29
00810051088458GuruNanda Water Flosser H3200A H3200A2025-06-27
00810051081787GURUNANDA DUAL-SLICKER FLOSS PICKGNF032025-05-06
00810051083415GURUNANDA ULTIMATE 2-IN-1 FLOSS & INTERDENTAL PICKGNF012025-05-06
10810051081784GURUNANDA DUAL-SLICKER FLOSS PICKGNF032025-05-06
10810051083412GURUNANDA ULTIMATE 2-IN-1 FLOSS & INTERDENTAL PICKGNF012025-05-06
00810051085532GURUNANDA EXPANDABLE FLOSSGNF022025-05-06
00810051086515GuruNanda Water Flosser R3100AR3100A 4.02025-04-02
00810051086843GuruNanda Kids Water FlosserRK1002025-04-02
00810051087048GuruNanda Compact Water Flosser, HM100HM1002025-04-02
00810051087055GuruNanda Compact Water Flosser,HM1002025-04-02
00810051087109GuruNanda Professional Whitening Wireless Kit1.02025-04-01
00810051086317GuruNanda Compact Water Flosser HM100HM1002025-02-26
00810051084702GuruNanda Steel Sonic TB - Rose Gold5500A2024-03-13
00810051084719GuruNanda Steel Sonic TB - Gold5500A2024-03-13
00810051084726GuruNanda Steel Sonic TB - Teal5500A2024-03-13
00810051084764GuruNanda Rotary Toothbrush - Lavederi20002024-03-13

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