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Sign in to claim this brandSUNSTAR AMERICAS, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 301 East Central Road, Schaumburg, IL, 60195
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1413787
- DUNS Number
- —
Catalogue (180)
Page 3 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Gum® | 4100 | FDA UDI | Class I | Active |
| Guidor | 5090 | FDA UDI | Class II | Unknown |
| Gum® | 871 | FDA UDI | Class I | Active |
| Gum® | 832 | FDA UDI | Class I | Active |
| Gum® | 1940 | FDA UDI | Class I | Active |
| Gum® | 612 | FDA UDI | Class I | Active |
| Gum® | 872 | FDA UDI | Class I | Active |
| Gum | 9935 | FDA UDI | Class I | Active |
| Gum® | KIT591 | FDA UDI | Class I | Active |
| Gum | KIT153 | FDA UDI | Class I | Active |
| Guidor | C11-008 | FDA UDI | Class II | Unknown |
| Gum® | 821 | FDA UDI | Class I | Active |
| Gum® | 614 | FDA UDI | Class I | Active |
| Gum® | 1612 | FDA UDI | Class I | Active |
| Gum® | 872 | FDA UDI | Class I | Active |
| Gum® | 3615 | FDA UDI | Class I | Active |
| Gum® | 3612 | FDA UDI | Class I | Active |
| Gum® | 230 | FDA UDI | Class I | Active |
| Gum® | 871 | FDA UDI | Class I | Active |
| Gum® | 3612 | FDA UDI | Class I | Active |
| Gum® | 625 | FDA UDI | Class I | Active |
| Gum® | 9691 | FDA UDI | Class I | Active |
| Gum® | 3014 | FDA UDI | Class I | Active |
| Gum® | 840 | FDA UDI | Class I | Active |
| Gum® | 3614 | FDA UDI | Class I | Active |
| Gum® | 891 | FDA UDI | Class I | Active |
| Gum® | 871 | FDA UDI | Class I | Active |
| Gum® | 2203 | FDA UDI | Class I | Active |
| Gum® | 4110 | FDA UDI | Class I | Active |
| Gum® | 872 | FDA UDI | Class I | Active |
| GUM Technique Deep Clean | 525 | FDA UDI | Class I | Active |
| Gum® | 618 | FDA UDI | Class I | Active |
| Gum® | 845 | FDA UDI | Class I | Active |
| Gum® | 612 | FDA UDI | Class I | Active |
| Gum® | 3210 | FDA UDI | Class I | Active |
| Guidor | 5050 | FDA UDI | Class II | Unknown |
| Gum® | 228 | FDA UDI | Class I | Active |
| Gum® | 2030 | FDA UDI | Class I | Active |
| Gum® | 872 | FDA UDI | Class I | Active |
| Gum® | 888 | FDA UDI | Class I | Active |
| Gum® | 898 | FDA UDI | Class I | Active |
| Gum® | 614 | FDA UDI | Class I | Active |
| Gum® | 472 | FDA UDI | Class I | Active |
| Gum® | 891 | FDA UDI | Class I | Active |
| Gum® | 706 | FDA UDI | Class I | Active |
| GUM Crayola Power Toothbrush | 9794 | FDA UDI | Class I | Active |
| Gum® | KIT35 | FDA UDI | Class I | Active |
| Gum® | 3200 | FDA UDI | Class I | Active |
| Gum® | 1815 | FDA UDI | Class I | Active |
| Gum® | 1415 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
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Authorities
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FDA Recalls (4)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 14, 2022 | Z-0720-2022 | — | terminated | Product lacks premarket clearance. |
| May 21, 2021 | Z-1837-2021 | — | terminated | Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans. |
| Mar 23, 2021 | Z-1382-2021 | — | terminated | Product may be contaminated with Burkholderia contaminans. |
| Feb 18, 2021 | Z-1182-2021 | — | terminated | The product may be contaminated with Burkholderia cepacia |