| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
055
|
Date of Entry 12/21/2020
|
|
FR Recognition Number
|
4-272
|
| Standard | |
ANSI ADA Standard No. 63-2013
Root Canal Barbed Broaches and Rasps |
|
Scope/Abstract| This standard specifies requirements and test methods for root canal instruments for hand use utilized in endodontic preparation. |
|
| 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| FDA recognition of ANSI ADA Standard No. 63-2013 [Rec# 4-272] will be superseded by recognition of ANSI ADA Standard No. 63-2020 [Rec# 4-330].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. |
