Device Explorer · FDA GUDID · GMDN 46432

Teeth whitening kit

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

US‑registered devices73in commercial distribution
Companies9labelers on GUDID
Single‑use8%of device records
Sterile0%labelled sterile
Prescription3%Rx‑only share
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Share of device records

Jiangxi Dentalbright Technology Co., Ltd2940%
Nu Radiance Inc2940%
Ortho Dental Lab Llc811%
Perio Sciences, Llc23%
Mavrik Dental System Inc.11%
Aldi Inc.11%
Orthofx11%
Straight Smile Llc11%

Top labelers

CompanyDevicesShare
Jiangxi Dentalbright Technology Co., Ltd2940%
Nu Radiance Inc2940%
Ortho Dental Lab Llc811%
Perio Sciences, Llc23%
Mavrik Dental System Inc.11%
Aldi Inc.11%
Orthofx11%
Straight Smile Llc11%
Discus Dental, Llc11%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Mavrik Dental SystemGlorySmileDr.DENT.coDentiguardSmileDirectClub Whitening plus Lip Balm - 4 PackSmileDirectClub Whitening Refill - 8 PackSmileDirectClub Whitening Pen - 4 Pack Plus LighSmileDirectClub Dissolving StripsGlo ScienceSmileSet Premium Sensitive Whitening StripsSmileSet Premium Whitening Kit – WhiteSmileSet Premium Whitening Kit – MintSmileSet Premium Whitening Kit – BlackBrightbyte Pro Refill PensPerio Sciences Replacement Tooth Whitening PensPerio Sciences LED Tooth Whitener

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
MAUEraser, Dental Stain40
EEGHeat Source For Bleaching Teeth6
EHMStrip, Polishing Agent1
EHYTray, Impression, Preformed1
LBHVARNISH, CAVITY1
OGTOral Irrigation Kit1

GMDN & GCC registration

  • GMDN code 46432 · non‑implantable
  • Single‑use 8% · sterile 0% · Rx‑only 3% · OTC 55%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many teeth whitening kit products are registered in the US?

73 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Teeth whitening kit", from 9 companies. The largest labeler is Jiangxi Dentalbright Technology Co., Ltd with 40% of records.

Which FDA product codes apply?

MAU (Eraser, Dental Stain), EEG (Heat Source For Bleaching Teeth), EHM (Strip, Polishing Agent), EHY (Tray, Impression, Preformed)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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