Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

055

Date of Entry 12/21/2020 

FR Recognition Number

4-271

Standard

ANSI ADA  Standard No. 34-2013
Dental Cartridge Syringes

Scope/Abstract

This standard specifies requirements and test methods for dental cartridge syringes which are reusable dental syringes of the aspirating, non-aspirating and self-aspirating types using cartridges with dental local anesthetics.

Extent of Recognition

Complete standard

Rationale for Recognition

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Public Law, CFR Citation(s) and Procode(s)*

Regulation Number	Device Name	Device Class	Product Code
§872.6770	Syringe, Cartridge	Class 2	EJI

Relevant FDA Guidance and/or Supportive Publications*

Guidance for Industry and Food and Drug Administration Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued March 2015.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.

FDA Technical Contacts

Lauren Giles   FDA/OC/CDRH/OPEQ/OHTI/DHTIB/   301-796-9552   lauren.giles@fda.hhs.gov

Bobak Shirmohammadi   FDA/OC/CDRH/OPEQ/OHTI/DHTIB/   301-796-3639   Bobak.Shirmohammadi@fda.hhs.gov

Michael Adjodha   FDA/OC/CDRH/OPEQ/OHTI/DHTIB/   301-796-6276   michael.adjodha@fda.hhs.gov

Standards Development Organizations

ANSI	American National Standards Institute	https://www.ansi.org/
ADA	American Dental Association	http://www.ada.org

FDA Specialty Task Group (STG)

Dental/ENT

*These are provided as examples and others may be applicable.