Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1413787

FEI Number

1413787

Entity Name

SUNSTAR AMERICAS, INC.

City/State/Country

Schaumburg, IL, US

Establishment Address

301 East Central Road, Schaumburg, IL 60195, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Sunstar Americas, Inc. (Owner Number: 9016423)

Owner / Operator Contact Address

301 E Central Rd, Schaumburg, IL 60195, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

G-U-M Lighted Mirror GUM Oral Care Cleaning Kit (EXPLORER, OPERATIVE) GUM® Orthodontic Wax +Vitamin E GUM® Orthodontic Wax Mint with Vitamin E and Aloe Vera PROPHYCIENCY BUTLER DUROPRO MONSTERZ EEZ-TOUCH GUM® Proxabrush Interdental Brush 1.2mm GUM® Proxabrush Interdental Brush 1.4mm GUM® Proxabrush Interdental Brush 1.6mm GUM® Proxabrush Interdental Brush 0.8mm GUM® Proxabrush Interdental Brush 0.6mm TRAV-LER GUM® Proxabrush Interdental Brush 1.3mm GUM® Proxabrush Interdental Brush 1.1mm GUM® SOFT-PICKS® Original GUM® SOFT-PICKS G-U-M Gum Stimulator G-U-M Gum Stimulator Refills BUTLERWEAVE CRAYOLA Eez-Thru G-U-M Floss Threaders FLOSSMATE Handle FLOSSBRUSH BUTLER Floss GUM® Floss DEEP CLEAN EXPANDING BARBIE PROFESSIONAL CLEAN PLUS LADY BUG DUAL-DEFENSE GUM® ECO FLOSSER COMFORT SLIDE Twisted Mint FINE ProWeave GUM® Original Flossers PROFESSIONAL CLEAN ADVANCE CARE GUM® Mint Floss TROLLS AVENGERS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EAX	Mirror, Mouth	Dental	Class 1	872.4565	1992-06-25
EKB	Explorer, Operative	Dental	Class 1	872.4565	2023-05-25
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	1992-06-25
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2024-11-11
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2008-01-16
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2023-03-01
JET	Pick, Massaging	Dental	Class 1	872.6650	1992-06-25
JES	Floss, Dental	Dental	Class 1	872.6390	1992-06-25

Official Correspondent

Paula Wendland

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sunstar Americas, 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
K821629	Moyco Industries, Inc.	FIXIDENT	1982-06-14
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10

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3004077103	KWANG MYUNG DAICOM LTD.	SEOUL, KR
9615399	DIADENT GROUP INTL., INC.	Vancouver British Columbia, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1413787. Last updated year: 2026. Please use registration number 1413787 when referencing this establishment in official correspondence.