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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 066 Date of Entry 05/25/2026 
FR Recognition Number 4-370
Standard
ANSI ADA  Standard No. 126-2015 (R2023)
Casting Investments and Refractory Die Materials
Scope/Abstract
This standard is applicable to dental casting, brazing and refractory investments and refractory die materials, regardless of the nature of the binding system or the particular application. This standard presents requirements for the essential physical and mechanical properties of the materials and the test methods used to determine them.

This standard is a modified adoption consisting of identical adoptions of ISO 15912:2006, Dentistry-Casting investments and refractory die materials and Amendment 1:2011, Requirement and test method for adequacy of expansion of Type 1 and Type 2 materials.
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
§872.3060 Alloy, Other Noble Metal Class 2 EJS
§872.3060 Alloy, Gold-Based Noble Metal Class 2 EJT
§872.3710 Alloy, Metal, Base Class 2 EJH
§872.3920 Teeth, Porcelain Class 2 ELL
§872.6660 Powder, Porcelain Class 2 EIH
Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Dental Noble Metal Alloys, issued August 2004.

2. Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Dental Base Metal Alloys, issued August 2004.

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
 Joel Anderson
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6520
  Joel.Anderson@fda.hhs.gov
 Ran Huo
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  240-402-6705
  Ran.Huo@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
ADA American Dental Association http://www.ada.org
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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