Product names: || a) Alginate Dental Impression Material Regular Set, Cinnamon Flavor, Pink Color || b) Alginate Dental Impression Material Regular Set, Mint Flavor, Pink Color || c) Alginate Dental Impression Material Regular Set, Mint Flavor, Pink Color, Dustless || d) Alginate Dental Impression Material Regular Set, Cherry Flavor, No color || e) Alginate Dental Impression Material Fast Set, Mint Flavor, Pink Color || f) Alginate Dental Impression Material Fast Set, Mint Flavor, Pink Color, Dustless || g) Alginate Dental Impression Material Fast Set, Cherry Flavor, No color || All are varieties of alginate dental impression powder packaged in aluminum foil pouches labeled as containing approximately 454 grams (one pound), or in the case of one foreign account, packaged in unlabeled 25 lb. and 39 lb. bulk containers. || The alginate impression material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient''s teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures. || This product was cleared as a prescription device; however, it is not labeled as such.
Distributed throughout the Continental United States and to several countries in the Caribbean and Central America.
Product Description
Product names: || a) Alginate Dental Impression Material Regular Set, Cinnamon Flavor, Pink Color || b) Alginate Dental Impression Material Regular Set, Mint Flavor, Pink Color || c) Alginate Dental Impression Material Regular Set, Mint Flavor, Pink Color, Dustless || d) Alginate Dental Impression Material Regular Set, Cherry Flavor, No color || e) Alginate Dental Impression Material Fast Set, Mint Flavor, Pink Color || f) Alginate Dental Impression Material Fast Set, Mint Flavor, Pink Color, Dustless || g) Alginate Dental Impression Material Fast Set, Cherry Flavor, No color || All are varieties of alginate dental impression powder packaged in aluminum foil pouches labeled as containing approximately 454 grams (one pound), or in the case of one foreign account, packaged in unlabeled 25 lb. and 39 lb. bulk containers. || The alginate impression material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient''s teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures. || This product was cleared as a prescription device; however, it is not labeled as such.