| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
065
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Date of Entry 12/22/2025
|
|
FR Recognition Number
|
4-365
|
| Standard | |
ISO 6873 Third edition 2013-04
Dentistry - Gypsum products |
|
Identical AdoptionANSI ADA Standards No. 25-2015 (R2021)
Dental Gypsum Products |
|
Scope/Abstract| ISO 6873:2013 gives a classification of, and specifies requirements for, gypsum products used for dental purposes such as making oral impressions, moulds, casts, dies or model bases, and mounting models. It specifies the test methods to be employed to determine compliance with these requirements. It also includes requirements for the labelling of packaging and for adequate instructions to accompany each package. |
|
| 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. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §872.3660 |
Material, Impression
|
Class 2
|
ELW
|
|
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 Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
