NYSDA Publications

FDA Takes Action Against Dental Manufacturer Medivance Instruments Ltd.

The United States Food and Drug Administration (FDA) has taken action against Medivance Instruments Ltd., the manufacturer of the Velopex Aquacut Fluid Abrasion Unit (“Velopex Device”) and various accessories as part of the Velopex AquaCare Dental Abrasion line of products.  These products are intended for use in a range of dental procedures, including sealant preparation, composite removal and restoration, and cavity preparation.  The FDA found that these products were misbranded and adulterated in violation of the Federal Food, Drug, and Cosmetic Act.  To read the FDA warning letter issued to Medivance Instruments Ltd., use the link below.