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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 4-390
Standard
ISO  15912 Second edition 2016-01
Dentistry - Refractory investment and die material
Scope/Abstract
ISO 15912:2016 gives requirements and test methods for determining the compliance of dental casting investment, dental brazing investment, dental pressable-ceramic investment and dental refractory die materials used in the dental laboratory, regardless of the composition of the refractory powder, the composition of the binder, or the particular application.

ISO 15912:2016 classifies such products into types and classes, according to their intended use and the burn-out procedure recommended by the manufacturer.

It also gives requirements for marking, labelling and manufacturer's instructions.

It specifies requirements for the essential physical and mechanical properties of the products and the test methods to be used for determining them.

NOTE 1 Compliance with all of the requirements presented in Clause 5 may not be necessary for some products, and a requirement might not be applicable to a product with a particular binder chemistry or be intended for an application in which that requirement is irrelevant. When this is the case, a clear statement to this effect is given according to Clause 5.

NOTE 2 A specific quantitative requirement for setting expansion is not included in this International Standard. If the setting expansion of gypsum-bonded investment is measured, then the procedure given in ISO 6873[1] can be considered a procedure not recommended, however, for investment materials with other binders.
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 Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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