FDA.reportPublic FDA data

Gemini

Primary DI
00857848007094
Brand
Gemini
Company
Beyond International Inc.
Model
BY-GM224
Published
2023-05-08
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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857848007094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857848007094008578480070948578480070940857848007094

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
080721790
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857848007124BEYOND® Polus® Advanced Whitening AcceleratorPLS-868A 2022-12-23
00857848007131BEYOND® II Whitening AcceleratorBE-8182022-12-23
00857848007209BEYOND® BlueSeal® Gingival Protection (5 pack) BY-PD022052022-12-23
00857848007216BEYOND® FlexiBlue® Comfort Cheek Retractors (5 pack)BY-PD01205M2022-12-23
00857848007223BEYOND® FlexiBlue® Comfort Cheek Retractors (5 pack)BY-PD01205L2022-12-23
00857848007292BEYOND® II Cheek Retractor (5 pack)BY-M0122022-12-23
00857848007315BEYOND® BlueSeal® Gingival Protection Twin PackBY-PD022022022-12-23
00857848007599BEYOND® FlexiPro™ Cheek Retractor (5 pack)-LBY-M015-L2022-12-23
00857848007605BEYOND® FlexiPro™ Cheek Retractor (single pack)-LBY-M016-L2022-12-23
00857848007674InPulse Dental LaserInPulse Touch 1002022-12-23
00857848007681BEYOND® FlexiPro™ Cheek Retractor (5 pack)-MBY-M015-M2022-12-23
00857848007698BEYOND® FlexiPro™ Cheek Retractor (single pack)-MBY-M016-M2022-12-23
00857848007704BEYOND® FlexiPro™ Cheek Retractor (5 pack)-MixedBY-M015-MIX2022-12-23
00857848007711BEYOND® Polus® Advanced Ultra Whitening AcceleratorPLS-868UL2022-12-23
00857848007728BEYOND® II Ultra Whitening AcceleratorBE-818UL2022-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00872320006440Picasso Pro Diode LaserCAO GROUP, INC.EEG2026-04-10
E241WR0040WR Premium Perfection Kit + LedCavex Holland B.V.EEG2026-03-09
08719327516041WR Premium Perfection Kit + LedCavex Holland B.V.EEG2026-03-09
E241WR0100WR Premium Perfection Kit Led EUCavex Holland B.V.EEG2026-03-09
E241BW0620Cavex Bite&White ExSense BrushpenCavex Holland B.V.EEG2026-03-05
E241BW1600Cavex Bite&White ExSense tubeCavex Holland B.V.EEG2026-03-05
E241BW0070Cavex Bite&White 3 syringes CP16Cavex Holland B.V.EEG2026-03-05
E241BW0080Cavex Bite&White 3 syringes CP22Cavex Holland B.V.EEG2026-03-05
E241BW0310Cavex Bite&White Ready 2 UseCavex Holland B.V.EEG2026-03-05
E241BW0500Cavex Bite&White In-Office 25% Starter Cavex Holland B.V.EEG2026-03-05
E241BW0510Cavex Bite&White In-Office 25% Pen bulkCavex Holland B.V.EEG2026-03-05
E241BW0520Cavex Bite&White In-Office 25% Barrier bulkCavex Holland B.V.EEG2026-03-05
08719327516058Cavex Bite&White ExSense BrushpenCavex Holland B.V.EEG2026-03-05
E241BW0820Cavex Bite&White Aligner Whitening penCavex Holland B.V.EEG2026-03-05
08720299509207Cavex Bite&White ExSense tubeCavex Holland B.V.EEG2026-03-05
00850079280397CavexHexa DentalEEG2026-01-22
00850079280403CavexHexa DentalEEG2026-01-22
00850079280410CavexHexa DentalEEG2026-01-22
00850079280137HEXAHexa DentalEEG2026-01-21
00850079280144HexaHexa DentalEEG2026-01-21
00301260033211Colgate Optic White Professional In Office Whitening KitCOLGATE ORAL PHARMACEUTICALS, INC.EEG2025-11-06
00860012825516SmileDirectClub Whitening Pen - 9 Pack Plus LightOrtho Dental Lab LLCEEG2025-10-16
00860012825530SmileDirectClub Whitening Pen - 4 Pack Plus LightOrtho Dental Lab LLCEEG2025-10-16
00850078989123SmileSet Premium Whitening Kit – BlackOrtho Dental Lab LLCEEG2025-09-25
00850078989130SmileSet Premium Whitening Kit – MintOrtho Dental Lab LLCEEG2025-09-25
00850078989147SmileSet Premium Whitening Kit – WhiteOrtho Dental Lab LLCEEG2025-09-25
06974624062116PIOONWuhan Pioon Technology Co., Ltd.EEG2025-07-08
06974624062109PIOONWuhan Pioon Technology Co., Ltd.EEG2025-07-07
06972868590013AHVTEFOSHAN OUSIDUN PERSONAL CARE PRODUCTS CO.,LTDEEG2025-05-06
06972868590020AHVTEFOSHAN OUSIDUN PERSONAL CARE PRODUCTS CO.,LTDEEG2025-05-06