Recognized standard

Standard No. 47-2-2021

FDA recognition 4-342 · ANSI · Dental/ENT

Key facts

Recognition number 4-342
Designation Standard No. 47-2-2021
Title Stationary Dental Units and Patient Chairs-Part 2: Air, Water, Suction and Wastewater Systems
Standards developer American National Standards Institute
Specialty area Dental/ENT
Date of entry May 26, 2025
Device classes Class 1
Scope (excerpt) This document specifies requirements and test methods concerning: a) the configuration of dental unit connections to the compressed air supply, water supply, suction supply, and wastewater drain plumbing, b) the materials, design, and construction of the compressed air and water system within the…

At a glance

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  • 1–9 FDA guidance documents

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