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Medivance Instruments Ltd. was cited for manufacturing the Velopex Aquacut Fluid Abrasion Unit and related dental devices without adequate regulatory authorization, as the products underwent significant design modifications—including a new air regulator and changes to powder tubing materials—that exceeded the scope of the company's original 510(k) clearance issued in 2003. The FDA determined that these material changes to device components, manufacturing methods, and operating parameters constituted modifications substantial enough to require new premarket notification, yet the company continued marketing the devices without obtaining updated clearance or demonstrating substantial equivalence to predicate devices. The warning was issued following an FDA inspection conducted in August 2022 at the company's London, United Kingdom facility, and the company's September 2022 response was found inadequate to address the identified violations.