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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 066 Date of Entry 05/25/2026 
FR Recognition Number 4-393
Standard
ISO  21533 Second edition 2018-01
Dentistry - Reprocessable cartridge syringes for intraligamentary injections
Identical Adoption
ANSI ADA Standard No. 183-2020
Reprocessable Cartridge Syringes for Intraligamentary Injections
Scope/Abstract
ISO 21533:2018 specifies requirements and test methods for reprocessable cartridge syringes intended for intraligamentary injections.

ISO 21533:2018 specifies requirements for cartridge syringes with ISO metric thread sizes, and only intended for intraligamentary injections. However, attention is drawn to the existence of a variety of syringes with imperial thread sizes (see Annex A).
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
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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