| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
065
|
Date of Entry 12/22/2025
|
|
FR Recognition Number
|
4-349
|
| Standard | |
ANSI ADA Standard No. 34-2025
Dental Cartridge Syringes |
|
Scope/Abstract
This is a modified adoption of ISO 9997 Third edition 2020-01 Dentistry-Cartridge syringes. |
|
| 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| FDA recognition of ANSI ADA Standard No. 34-2013 [Rec# 4-271] will be superseded by recognition of ANSI ADA Standard No. 34-2025 [Rec# 4-349]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-271] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 4-271] will not be accepted. |
|
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
|
| Standards Development Organizations
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
