35newtons L.L.C.

35newtons L.L.C. specializes in antimicrobial dental prosthesis/implant plugs. These devices are specifically designed to help prevent microbial colonization in dental implants and prostheses, ensuring better long-term outcomes for patients.

The company is headquartered in the United States. This location allows it to comply with U.S. regulatory requirements for medical devices, including those related to antimicrobial dental implants.

The devices produced by 35newtons L.L.C., such as FirstPlug and FirstPlug Alpha 2.0, are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S.

The company’s devices fall under the FDA’s Class I classification. This classification is typically assigned to low-risk medical devices, such as antimicrobial dental prosthesis/implant plugs, which require less stringent regulatory oversight compared to higher-risk categories.