Sunstar Americas, Inc.
Schaumburg, IL, US
SUNSTAR AMERICAS, INC. appears in FDA device records in Schaumburg, IL. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Sunstar Americas, Inc. between 2011 and 2018. The busiest year on record is 2011, with 1. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2013 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K181134 | G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray | LFD | Substantially Equivalent | |
| K132325 | GUIDOR BIORESORBABLE MATRIX BARRIER | NPK | Substantially Equivalent | |
| K102053 | BUTLER CALCI-FLOR PROPHYLAXIS PASTE | EJR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1413787 | 1413787 | SUNSTAR AMERICAS, INC. | 301 East Central Road, Schaumburg, IL 60195 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0720-2022 | BUTLER Clear Dip, 12 bottles/case | Product lacks premarket clearance. | Class II | Terminated | |
| Z-1837-2021 | 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 plaque causing bacteria. | Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans. | Class II | Terminated | |
| Z-1382-2021 | SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA | Product may be contaminated with Burkholderia contaminans. | Class II | Terminated | |
| Z-1182-2021 | 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, sweeteners and flavors that collectively have lubricating, moisturizing, soothing, and refreshing properties to help relieve and manage the symptoms of dry mouth. | The product may be contaminated with Burkholderia cepacia | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain