Data / Medical devices / United States / Sunstar Americas, Inc.
Sunstar Americas, Inc.: FDA-registered device maker in Schaumburg, IL, United States, 3 510(k) clearances
Sunstar Americas, Inc. is registered with the FDA (registration 1413787) in Schaumburg, IL, United States. It lists 10 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 16, 1998. 4 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1413787
- Address
- 301 East Central Road, Schaumburg, IL, United States, 60195
- Owner or operator
- Sunstar Americas, Inc. (9016423)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- June 25, 1992
- Registered through
- 2027
- Brand names listed
- BARBIE Power Toothbrush, BUTLER, BUTLER Floss, BUTLERWEAVE Floss, CRAYOLA Power Toothbrush, Crayola® Twistables Kid's Flossers, DUROPRO, Dual Action Tongue Cleaner and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cup, Prophylaxis | EHK | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Explorer, Operative | EKB | 1 | Specification developer | accessdata.fda.gov |
| Floss, Dental | JES | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pick, Massaging | JET | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scaler, Periodontic | EMN | 1 | Specification developer | accessdata.fda.gov |
| Scraper, Tongue | LCN | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Toothbrush, Powered | JEQ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 16, 1998 | K974761 | BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH | EFW | Substantially Equivalent | John O. Butler Co. | accessdata.fda.gov |
| June 28, 1995 | K952091 | VUTLER G.U.M. WITH FLUORIDE | JES | Substantially Equivalent | John O. Butler Co. | accessdata.fda.gov |
| June 2, 1995 | K950993 | BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH | EFW | Substantially Equivalent | John O. Butler | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 14, 2022 | 89460 | Class II | Terminated | BUTLER Clear Dip, 12 bottles/case | Product lacks premarket clearance. | accessdata.fda.gov |
| May 21, 2021 | 87976 | Class II | Terminated | SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from pla | Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans. | accessdata.fda.gov |
| March 23, 2021 | 87600 | Class II | Terminated | SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA | Product may be contaminated with Burkholderia contaminans. | accessdata.fda.gov |
| February 18, 2021 | 87371 | Class II | Terminated | SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 - Product Usage: The device is formulated with water, moisturizers /humectants including one plant-based moisture rich humectant, s | The product may be contaminated with Burkholderia cepacia | accessdata.fda.gov |
Compare with other makers
- All makers of Explorer, Operative
- All makers of Floss, Dental
- All makers of Toothbrush, Manual
- All makers of Scaler, Periodontic
- All makers of Cup, Prophylaxis
- All makers of Toothbrush, Powered
Updated June 16, 1998. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.