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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 063 Date of Entry 12/23/2024 
FR Recognition Number 4-337
Standard
ISO  20608 First edition 2018-04
Dentistry - Powder jet handpieces and powders
Scope/Abstract
ISO 20608:2018 specifies the general requirements, test methods, manufacturer's information, marking and packaging, independently of the design of the powder jet handpieces (see Figure 1).

ISO 20608:2018 applies to powder jet handpieces and their associated powders for use in the field of dentistry. They are used on patients to remove dental debris, discolourations and plaque and to clean and polish teeth where abrasion is a side effect.

ISO 20608:2018 is also applicable to powder jet handpieces and their associated powders that are used in dentistry for air driven abrasion, e.g. minimally invasive cavity preparation, preparation of surfaces for adhesives and for the removal of cement residues where abrasion is part of the desired outcome.

ISO 20608:2018 is not applicable for the dental units that are employed to supply the powder jet handpieces.

ISO 20608:2018 is not applicable to dental prophylaxis handpieces (contra angles), or electrically driven plaque removers (scalers) or multifunctional handpieces (syringes).
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
§872.4200 Handpiece, Air-Powered, Dental Class 1 EFB
§872.6030 Agent, Polishing, Abrasive, Oral Cavity Class 1 EJR
§872.6080 Prophy Powder, Airbrush Accessory Class 2 PIP
Relevant FDA Guidance and/or Supportive Publications*
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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