FDA.reportPublic FDA data

Teeth whitening kit

Definition
A 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.
GUDID devices
74
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00860012825523SmileDirectClub Dissolving StripsOrtho Dental Lab LLC130-01012025-10-16
00860012825530SmileDirectClub Whitening Pen - 4 Pack Plus LightOrtho Dental Lab LLC150-01422025-10-16
00860012825547SmileDirectClub Whitening Refill - 8 PackOrtho Dental Lab LLC130-01022025-10-16
00860012825561SmileDirectClub Whitening plus Lip Balm - 4 PackOrtho Dental Lab LLC150-01432025-10-16
04061464611665DentiguardAldi Inc.7094762023-02-13
07290113770010Mavrik Dental SystemMavrik Dental System Inc.12023-11-01
00850078989123SmileSet Premium Whitening Kit – BlackOrtho Dental Lab LLC150-01192025-09-25
00850078989130SmileSet Premium Whitening Kit – MintOrtho Dental Lab LLC150-01202025-09-25
00850078989147SmileSet Premium Whitening Kit – WhiteOrtho Dental Lab LLC150-01212025-09-25
00850078989178SmileSet Premium Sensitive Whitening StripsOrtho Dental Lab LLC150-01242025-09-25
00353238006208Perio Sciences LED Tooth WhitenerPerio Sciences, LLC106202024-02-08
00353238106212Perio Sciences Replacement Tooth Whitening PensPerio Sciences, LLC106212024-02-08
27290113770120Mavrik Dental SystemMavrik Dental System Inc.12023-11-01
06970016620643GlorySmileJiangxi Dentalbright Technology Co., LtdGS-0012022-12-21
06970016621404GlorySmileJiangxi Dentalbright Technology Co., LtdGS-003C/P/H2023-02-22
06970016621534GlorySmileJiangxi Dentalbright Technology Co., LtdGS-013H2023-02-22
06970016621831GlorySmileJiangxi Dentalbright Technology Co., LtdGS-SK2023-02-22
06970016621879GlorySmileJiangxi Dentalbright Technology Co., LtdGS-003Z2023-02-22
06970016622005GlorySmileJiangxi Dentalbright Technology Co., LtdGS-002W2023-02-22
06970016622807GlorySmileJiangxi Dentalbright Technology Co., LtdGS-JK2023-02-22
06970016622920GlorySmileJiangxi Dentalbright Technology Co., LtdGS-003B2023-02-22
06970016623057GlorySmileJiangxi Dentalbright Technology Co., LtdGS-002B2023-02-22
06970016623200GlorySmileJiangxi Dentalbright Technology Co., LtdGS-001YF2023-02-22
06970016623293GlorySmileJiangxi Dentalbright Technology Co., LtdGS-003-H2023-02-22
06970016624030GlorySmileJiangxi Dentalbright Technology Co., LtdGS-0012023-02-22
06970016624481GlorySmileJiangxi Dentalbright Technology Co., LtdGS-001Y2023-02-22
06970016624887GlorySmileJiangxi Dentalbright Technology Co., LtdGS-012C2023-02-22
06970016625006GlorySmileJiangxi Dentalbright Technology Co., LtdGS-013VF2023-02-22
06970016625891GlorySmileJiangxi Dentalbright Technology Co., LtdGS-001C2023-02-22
06970016626140GlorySmileJiangxi Dentalbright Technology Co., LtdGS-001A2023-02-22
06970016626232GlorySmileJiangxi Dentalbright Technology Co., LtdGS-DP2023-02-22
06970016627413GlorySmileJiangxi Dentalbright Technology Co., LtdGS-003N2023-02-22
06970016627567GlorySmileJiangxi Dentalbright Technology Co., LtdGS-013V2023-02-22
06970016627680GlorySmileJiangxi Dentalbright Technology Co., LtdGS-001RB2023-02-22
06970016628182GlorySmileJiangxi Dentalbright Technology Co., LtdGS-013N2023-02-22
06970016629196GlorySmileJiangxi Dentalbright Technology Co., LtdGS-003-EFG2023-02-22
06970016629554GlorySmileJiangxi Dentalbright Technology Co., LtdGS-001NR2023-02-22
06970016629608GlorySmileJiangxi Dentalbright Technology Co., LtdGS-003R2023-02-22
06970016629813GlorySmileJiangxi Dentalbright Technology Co., LtdGS-003-ABCD2023-02-22
06970016629851GlorySmileJiangxi Dentalbright Technology Co., LtdGS-003D2023-02-22
06970016624504Dr.DENT.coJiangxi Dentalbright Technology Co., LtdDD-USRLK2023-02-16
06970016625198GlorySmileJiangxi Dentalbright Technology Co., LtdGS-001D2023-02-16
00850017524118Brightbyte Pro Refill PensSTRAIGHT SMILE LLCBBPRP2022-06-06
B77221070ClassicNU RADIANCE INC50 Syringe Pack2022-03-29
B77221140ClassicNU RADIANCE INC50 Syringe Pack2022-03-29
B77221210ClassicNU RADIANCE INC50 Syringe Pack2022-03-29
B7722138ClassicNU RADIANCE INC50 Syringe Pack2022-03-29
B72206150DuetNU RADIANCE INCMaintenance Kit2021-08-17
B72206480DuetNU RADIANCE INCEight Syringe Pack2021-08-17
B77201270ClassicNU RADIANCE INCMaintenance Kit2021-08-17
B77201340ClassicNU RADIANCE INCPatient Kit2021-08-17
B77201430ClassicNU RADIANCE INCTen Syringe Pack2021-08-17
B77201500ClassicNU RADIANCE INC36 Syringe Bulk Pack2021-08-17
B77202260ClassicNU RADIANCE INCMaintenance Kit2021-08-17
B77202330ClassicNU RADIANCE INCPatient Kit2021-08-17
B77202420ClassicNU RADIANCE INCTen Syringe Pack2021-08-17
B77202590ClassicNU RADIANCE INC36 Syringe Bulk Pack2021-08-17
B77203250ClassicNU RADIANCE INCMaintenance Kit2021-08-17
B77203320ClassicNU RADIANCE INCPatient Kit2021-08-17
B77203410ClassicNU RADIANCE INCTen Syringe Pack2021-08-17
B77203580ClassicNU RADIANCE INC36 Syringe Bulk Pack2021-08-17
B77203650ClassicNU RADIANCE INCMaintenance Kit2021-08-17
B77203720ClassicNU RADIANCE INCPatient Kit2021-08-17
B77203890ClassicNU RADIANCE INCTen Syringe Pack2021-08-17
B77203960ClassicNU RADIANCE INC36 Syringe Bulk Pack2021-08-17
B77209290Eure-CaNU RADIANCE INCTen Syringe Pack2021-08-17
B77206220DuetNU RADIANCE INCPatient Kit2021-08-16
B77206530DuetNU RADIANCE INC36 Syringe Bulk Pack2021-08-16
B77208130ForteNU RADIANCE INCMaintenance Kit2021-08-16
B77208150ForteNU RADIANCE INCTouch Up Kit2021-08-16
B77208200ForteNU RADIANCE INCPatient Kit2021-08-16
B77208530ForteNU RADIANCE INC36 Syringe Bulk Pack2021-08-16
00860003321720Glo ScienceORTHOFX6HPGT-rev2020-11-24
18600033217209Glo ScienceORTHOFX6HPGT2020-03-18