Home › Device types › KOO
Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
FDA product code KOO · Class 1 · Dental
12
Registered devices
773
Adverse events
3
Recalls
4
510(k) clearances
Devices with this code
DG Health — DOLGENCORP, LLCStaydent — SHEFFIELD PHARMACEUTICALS, LLCFreshmint — NEW WORLD IMPORTS, INC.Freshmint — NEW WORLD IMPORTS, INC.CareALL — NEW WORLD IMPORTS, INC.SECURE Denture Adhesive — FITTYDENT INTERNATIONAL GmbHDyna Care Denture Adhesive — Dynarex CorporationSECURE Denture Adhesive Sensitive — FITTYDENT INTERNATIONAL GmbHAffinity™ Tray Adhesive — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.Affinity™ Tray Adhesive — DEN-MAT HOLDINGS, LLCDawnMist — Dukal LLCRexall — DOLGENCORP, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-10-04 | Family Dollar Stores, Llc. | Products were stored outside of labeled temperature requirements. |
| 2022-06-23 | Family Dollar Stores, Llc. | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. |
| 2022-06-23 | Family Dollar Stores, Llc. | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. |
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