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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 4-382
Standard
ISO  13078-2 First edition 2016-07
Dentistry - Dental furnace - Part 2: Test method for evaluation of furnace programme via firing glaze
Identical Adoption
ANSI ADA Standard No. 164-2018 (R2023)
Dental Furnance, Part 2: Test Method for Evaluation of Furnace Program via Firing Glaze
Scope/Abstract
ISO 13078-2:2016 determines a degree of firing to be implemented by the user. It represents a test method for adapting the firing program of a dental furnace by determining the degree of firing of fired test specimens for a dental ceramic.

The test method is suitable for powdered dental ceramics according to ISO 6872, Type I.

The test method enables monitoring of the temperature control in the dental furnace by evaluating the firing degree of a dental ceramic. The test method is also suitable for evaluating the reproducibility of the firings in a dental furnace or for comparing several dental furnaces.
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
§872.3920 Teeth, Porcelain Class 2 ELL
§872.6660 Powder, Porcelain Class 2 EIH
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
 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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