Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
|
063
|
Date of Entry 12/23/2024
|
FR Recognition Number
|
4-330
|
Standard | |
ANSI ADA Standard No. 63-2020 Endodontic Instruments - Auxillary |
|
Scope/AbstractThis standard specifies requirements and test methods for hand-held or mechanically operated instruments for performing root canal procedures not cited in ANSI/ADA Standard Nos. 28, 71, 95 or 101. It also specifies requirements for size, product designation, safety considerations, instructions and labeling.
This standard is a modified adoption of ISO 3630-4:2009 Dentistry - Root canal instruments - Part 4: Auxiliary instruments. |
|
Extent of Recognition
|
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. |
|
Transition Period
FDA recognition of ANSI ADA Standard No. 63-2013 [Rec# 4-272] will be superseded by recognition of ANSI ADA Standard No. 63-2020 [Rec# 4-330]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-272] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 4-272] will not be accepted. |
|
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§872.4565 |
Broach, Endodontic
|
Class 1
|
EKW
|
|
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
|
Standards Development Organizations
|
FDA Specialty Task Group (STG)
|
*These are provided as examples and others may be applicable. |