Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013520830

FEI Number

3013520830

Entity Name

WSD LABS USA INC

City/State/Country

Tonawanda, NY, US

Establishment Address

255 Cooper Ave, Suite 110, Tonawanda, NY 14150, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

WSD LABS USA INC (Owner Number: 10056909)

Owner / Operator Contact Address

255 Cooper Ave, Suite 110, Tonawanda, NY 14150, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Teeth Wipes,Brush Ups,Finger Brush,Oral Brush Ups Vitamin E Swab Smart Teeth Whitening Device; Smart Teeth Whitening Light; Teeth Whitening Lamp; Teeth Whitening Accelerator; Teeth Whitening Mini Light; Mini Light 1led/5led;Teeth Whitening Light 8led/16led; Teeth Whitening Mouth Tray Light Plusma Light; Teeth Whitening Light; Teeth whitening Led Light; Portable Teeth Whitening Light; Teeth whitening Led Light 8led/16led; Teeth Whitening Mouth Tray Led Light; VivaStyle Whitening LED Kit Cheek Retractor/Mouth Opener/Lip Retractor Denture Cleansing Tablet Thermoplastic Mouth Tray/Mouth Piece/Teeth Whitening Mouth Tray/Foam Strip Mouth Tray/Gel Prefilled Mouth Tray Remineralization Gel/Desensitizing Gel/Teeth Whitening Kit/Teeth Whitening Home Kit/Teeth Whitening System; Coconut oil pulling; Coconut oil sachet Teeth Whitening Pen/Bleaching Pen/Teeth Whitener/Teeth Whitening Gel 3ml/5ml/10ml/PROFESSIONAL WHITENING GEL; Dual Barrel Gel, Double Barrel Gel, Dual Barrel Syring Gel, Double Barrel Syringe Gel; Teeth Bleaching System/Teeth Bleaching Kit/Teeth Whitening Strips/Double Elastic Gel Strips Dry Strips/Dissolving Strip; teeth whitening powder; charcoal teeth whitening powder Syringe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2018-01-30
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2018-01-29
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2018-01-30
EIG	Retractor, All Types	Dental	Class 1	872.4565	2018-01-30
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2018-01-30
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2018-01-30
MAU	Eraser, Dental Stain	Dental	Class 1	872.6855	2018-01-30
EIB	Syringe, Irrigating (Dental)	Dental	Class 1	872.4565	2018-08-22

Official Correspondent

Gregory Heward

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

WSD LABS USA INC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013520830. Last updated year: 2026. Please use registration number 3013520830 when referencing this establishment in official correspondence.