FDA.reportPublic FDA data

Osstem Implant Co.,Ltd.

Primary DI
08800000995755
Brand
Osstem Implant Co.,Ltd.
Company
Osstem Implant Co.,Ltd.
Model
BeauTis White Light
Device description
The BeauTis White Light is a teeth whitening lamp that emits visible light to discolored teeth arter applying whitener in order to achieve whitening effect.The BeauTis White Light is a medical device that can be used by male and female adults and can be operated by an individual.The BeauTis White Light is classifiled as Class ll and Type BF applied part.The nornal maximum operation condition is 5 min operation, 5 min rest for BeauTis White Light.The degree of protection against harmful ingress of water is IP21
Published
2022-11-30
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
08800000995755PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800000995755088000009957558800000995755

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
694893867
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800000996264OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSK52025-09-04
08800000995977OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSK52025-04-24
08800000995984OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSK52025-04-24
08800000996042T2 PlusT2-CS-P2025-04-28
08800000996059T2 PlusT2-C-P2025-04-28
08800209338841Estar-ZEZEHTA2012M2024-12-03
08800209338865Estar-ZEZEHTA2014M2024-12-03
08800209338889Estar-ZEZEHTA2016M2024-12-03
08800209338902Estar-ZEZEHTA2018M2024-12-03
08800209338926Estar-ZEZEHTA2020M2024-12-03
08800209338940Estar-ZEZEHTA2022M2024-12-03
08800209338964Estar-ZEZEHTA2025M2024-12-03
08800209338988Estar-ZEZEHTA2030M2024-12-03
08800209339008Estar-ZEZEHTA3010M2024-12-03
08800209339022Estar-ZEZEHTA3012M2024-12-03
08800209339046Estar-ZEZEHTA3014M2024-12-03
08800209339060Estar-ZEZEHTA3016M2024-12-03
08800209339084Estar-ZEZEHTA3018M2024-12-03
08800209339107Estar-ZEZEHTA3020M2024-12-03
08800209339121Estar-ZEZEHTA3022M2024-12-03

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