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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 050 Date of Entry 09/17/2018 
FR Recognition Number 4-247
Standard
ISO  28319 Second edition 2018-04
Dentistry - Laser welding and filler materials
Identical Adoption
ANSI ADA Standard No. 84-2020
Laser Welding and Filler Materials in Dentistry
Scope/Abstract
This document specifies requirements and test methods for laser welding and the filler materials thereto used in the dental laboratory for welding of metallic restorations and appliances.

For filler materials used in laser welding, this document also specifies the information given in the instructions for use, marking and labelling.
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
Relevant FDA Guidance and/or Supportive Publications*
Class II Special Controls Guidance Document: Dental Noble Metal Alloys - Guidance for Industry and FDA Staff, Issued August 2004.

Class II Special Controls Guidance Document: Dental Base Metal Alloys - Guidance for Industry and FDA Staff, 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
 Michael Adjodha
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6276
  michael.adjodha@fda.hhs.gov
 Joel Anderson
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6520
  joel.anderson@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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