Manufacturer registered with FDA
Sunstar Americas, Inc.
Schaumburg, IL, United States. Lists 10 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 10
- Brands and models
- 76
- 510(k) clearances
- 22011–2013
- Markets registered in
- 61,008 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Sunstar Americas, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Sunstar Americas, Inc. | 2 clearances | 2011–2013 | Below |
| Colombia | INVIMA | Registration holder | SUNSTAR AMERICAS INCSUNSTAR AMERICAS, INC · SUNSTAR AMERICAS, INC. | 980 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | SUNSTAR AMERICAS INC. | 18 | 2002–2023 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SUNSTAR AMERICAS, INC.SUNSTAR AMERICAS INC. | 6 | 2006–2021 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SUNSTAR AMERICAS, INC. | 2 | 2015–2019 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SUNSTAR AMERICAS, INC | 2 | 2022–2022 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Sunstar Americas, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | GUM® AVENGERS ToothbrushGUM® Bright Care ToothbrushGUM® Classic ToothbrushGUM® CRAYOLA Marker ToothbrushGUM® Denticare ToothbrushGUM® Denture ToothbrushGUM® Dome Trim ToothbrushGUM® End-Tuft ToothbrushGUM® Hot Wheels ToothbrushGUM® Junior MONSTERZ Manual Toothbrush (5+) 23 moreGUM® Kids Sponge Bob Manual ToothbrushGUM® Multi-Clean ToothbrushGUM® Original White ToothbrushGUM® Ortho Travel ToothbrushGUM® Paw Patrol Kids Travel toothbrushGUM® Paw Patrol Light Up ToothbrushGUM® PAW PATROL ToothbrushGUM® Proxabrush Interdental Brush 0.6mmGUM® Proxabrush Interdental Brush 0.8mmGUM® Proxabrush Interdental Brush 1.1mmGUM® Proxabrush Interdental Brush 1.2mmGUM® Proxabrush Interdental Brush 1.3mmGUM® Proxabrush Interdental Brush 1.4mmGUM® Proxabrush Interdental Brush 1.6mmGUM® Sponge Bob Kids Travel toothbrushGUM® Technique Enamel Clean ToothbrushGUM® Technique Esmalte Clean ToothbrushGUM® Technique Kids ToothbrushGUM® TECHNIQUE ToothbrushGUM® Tooth and Tongue ToothbrushGUM® Travel ToothBrushTRAV-LERTROLLS Manual Toothbrush | 1992 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | BUTLER FlossBUTLERWEAVE FlossCrayola® Twistables Kid's FlossersFLOSSBRUSHGUM® ADVANCE CARE FLOSSERSGUM® Advanced Care FlossersGUM® COMFORT SLIDE FLOSSERSGUM® DEEP CLEAN EXPANDING FlossGUM® DUAL-DEFENSE FLOSSGUM® ECO FLOSSER 12 moreGUM® Eez-Thru FlossGUM® FINE FLOSSGUM® FlossGUM® Floss ThreadersGUM® FLOSSMATE HandleGUM® Mint FlossGUM® Original FlossersGUM® PROFESSIONAL CLEAN FLOSSGUM® PROFESSIONAL CLEAN FLOSSERSGUM® PROFESSIONAL CLEAN PLUS FLOSSERSGUM® ProWeave FlossGUM® Twisted Mint Flossers | 1992 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | G-U-M Lighted Mirror | 1992 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | GUM® Ortho Wax + Vitamin EGUM® Ortho Wax + Vitamin E & Aloe VeraGUM® Orthodontic Wax +Vitamin EGUM® Orthodontic Wax Mint with Vitamin E and Aloe Vera | 1992 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | BUTLERDUROPROEEZ-TOUCHMONSTERZPROPHYCIENCY | 2008 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Maker | GUM Oral Care Cleaning Kit (EXPLORER, OPERATIVE) | 2023 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | GUM Oral Care Cleaning Kit (SCALER, PERIODONTIC) | 2023 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | BARBIE Power ToothbrushCRAYOLA Power ToothbrushGUM® Sonic Powered Toothbrush Heads | 2001 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | G-U-M Gum StimulatorG-U-M Gum Stimulator RefillsGUM® SOFT-PICKSGUM® SOFT-PICKS® Original | 1992 |
| Tongue ScraperLCN · Class 1 | — | Maker | Dual Action Tongue CleanerG-U-M Tongue Scraper | 2002 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Sunstar Americas, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 29 Oct 2013 | K132325 | GUIDOR BIORESORBABLE MATRIX BARRIER | NPK Intraoral Synthetic Barrier |
| 3 Feb 2011 | K102053 | BUTLER CALCI-FLOR PROPHYLAXIS PASTE | EJR Oral Cavity Abrasive Polishing Agent |
Some of these clearances are listed with FDA today by another company: Collagen Matrix, Inc. (1).
Also lists devices cleared under other names
Sunstar Americas, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: John O. Butler Co. (3).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 16 Jun 1998 | K974761 | BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH | John O. Butler Co. | EFW Manual Toothbrush |
| 28 Jun 1995 | K952091 | VUTLER G.U.M. WITH FLUORIDE | John O. Butler Co. | JES Dental Floss |
| 2 Jun 1995 | K950993 | BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH | John O. Butler Co. | EFW Manual Toothbrush |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SUNSTAR AMERICAS, INC.FDA reg. 1413787 | Schaumburg, IL, United States | Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9016423). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.