Recognized standard

7494-2 Second edition 2015-04-01

FDA recognition 4-221 · ISO · Dental/ENT

Key facts

Recognition number 4-221
Designation 7494-2 Second edition 2015-04-01
Title Dentistry - Dental units - Part 2: Air, water, suction and waste water systems
Standards developer International Organization for Standardization
Specialty area Dental/ENT
Date of entry Apr 4, 2016
Device classes Class 1
Scope (excerpt) This part of ISO 7494 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…

At a glance

  • 1–9 Product codes
  • 1–9 FDA guidance documents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA-recognized consensus standards

The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.

Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date:

Browse all FDA-recognized consensus standards