COLGATE ORAL PHARMACEUTICALS, INC.

Colgate Oral Pharmaceuticals, Inc. specializes in dental devices primarily used by professionals or patients under supervision. Their portfolio includes professional dental coatings and varnishes for tooth desensitization, such as flavored unit-dose applications (e.g., caramel, raspberry, grape, and mint). They also produce dental floss and tooth-bleaching systems, including take-home and in-office whitening kits designed for professional use. These devices are intended for direct application by dental practitioners or patient self-administration in a supervised setting.

Colgate Oral Pharmaceuticals, Inc. is based in the United States. Since the company operates domestically, its devices must comply with FDA regulations, including classification under the agency’s framework. This means their products—such as tooth-desensitizing varnishes and whitening kits—are subject to FDA oversight, including listing in the UDI database for traceability and regulatory transparency.

Colgate Oral Pharmaceuticals, Inc.’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry ensures each product has a unique identifier for tracking, compliance, and transparency in the medical device supply chain. Listing in the UDI system is required for Class I and Class II devices under FDA regulations, which includes the company’s dental coatings, whitening kits, and floss.

Colgate Oral Pharmaceuticals, Inc.’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. For example, tooth-desensitizing varnishes and professional whitening kits fall into these categories due to their intended use and potential impact on patient health, requiring compliance with specific FDA requirements.