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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
- —
- —
- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1413787
- DUNS Number
- —
Catalogue (180)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Gum® | KIT36 | FDA UDI | Class I | Active |
| Gum | KIT58 | FDA UDI | Class I | Active |
| Gum® | 2014 | FDA UDI | Class I | Active |
| Gum® | 612 | FDA UDI | Class I | Active |
| Gum® | 4110 | FDA UDI | Class I | Active |
| Gum® | 895 | FDA UDI | Class I | Active |
| Gum® | 1115 | FDA UDI | Class I | Active |
| Gum® | 414 | FDA UDI | Class I | Active |
| Gum® | 414 | FDA UDI | Class I | Active |
| Gum® | 2273 | FDA UDI | Class I | Active |
| Gum® | 3612 | FDA UDI | Class I | Active |
| Gum | KIT57 | FDA UDI | Class I | Active |
| Gum® | 3200 | FDA UDI | Class I | Active |
| GUM Dual Technique | 90189 | FDA UDI | Class I | Active |
| GUM Technique Sensitive Clean | 527 | FDA UDI | Class I | Active |
| Gum® | 874 | FDA UDI | Class I | Active |
| Gum® | 4110 | FDA UDI | Class I | Active |
| Gum® | 2008 | FDA UDI | Class I | Active |
| Gum® | 898 | FDA UDI | Class I | Active |
| Gum® | 462 | FDA UDI | Class I | Active |
| Gum® | 470 | FDA UDI | Class I | Active |
| Gum® | 887 | FDA UDI | Class I | Active |
| Guidor | C11-007 | FDA UDI | Class II | Unknown |
| Gum® | ORTHKITPRB | FDA UDI | Class I | Active |
| Gum® | KIT525 | FDA UDI | Class I | Active |
| GUM Technique Sensitive Clean | 527 | FDA UDI | Class I | Active |
| GUM Technique Sensitive Clean | 524CNL | FDA UDI | Class I | Active |
| G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray | K181134 | FDA 510(k) | U | Active |
| Guidor Bioresorbable Matrix Barrier | K132325 | FDA 510(k) | Class II | Active |
| Butler Calci-Flor Prophylaxis Paste | K102053 | FDA 510(k) | Class I | Active |
Related Companies
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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 |