APPLIED DENTAL, INC.

Applied Dental, Inc. specializes in sutures, which are used in surgical and medical procedures to close wounds or tissues. Their product range includes bioabsorbable sutures like polyester (monofilament and multifilament), polyglycolic acid, and poliglecaprone, as well as non-bioabsorbable options such as nylon (monofilament) and catgut (plain and chromic). These sutures vary in absorbability, strength, and material composition to suit different clinical applications.

Applied Dental, Inc. is based in the United States, which means their devices are subject to regulation by the U.S. Food and Drug Administration (FDA). Since they manufacture medical devices, their products must comply with FDA requirements, including classification, listing, and traceability through systems like the FDA’s Unique Device Identifier (UDI) database.

Applied Dental, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures that each device has a standardized identifier for traceability, compliance tracking, and transparency in the medical device supply chain. Listing in the UDI database is a requirement for many FDA-regulated devices in the U.S.

Applied Dental, Inc.’s sutures are classified under the FDA’s medical device classification system into three categories: Class I, Class II, and unclassified (U). The classification depends on factors like the risk associated with the device, its intended use, and potential health impacts. For example, lower-risk sutures may fall under Class I, while those requiring additional controls (like specific performance standards) may be Class II. Unclassified sutures may not yet have a formal classification assigned.