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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 4-383
Standard
ISO  13078-3 First edition 2023-05
Dentistry - Dental furnace - Part 3: Test method for the evaluation of high temperature sintering furnace measurement with a separate thermocouple
Identical Adoption
ANSI ADA Standard No. 209-2024
Dentistry - Test Method for the Evaluation of High Temperature Sintering Furnace Measurement with a Separate Thermocouple
Scope/Abstract
This document specifies a test method for the calibration of resistance-heated high temperature sintering furnaces that are suitable for the sintering of dental restorations in the temperature range up to 1 700 °C.

NOTE A test method for the calibration of dental furnaces that are suitable for the heat treatment of silica-based dental ceramic restorations in the temperature range between 600 °C and 1 050 °C is specified in ISO 13078:2013. ISO 13078:2013 does not include the calibration of sintering furnace used for sintering of oxide ceramics or sintered metal, in whose firing chamber restorations are sintered at temperatures of 1 000 °C to 1 700 °C.
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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