Document Details
Name of Department/Committee : MHD 08
Document Number : MHD 08 ( 27944)
Document Title [English] : Dentistry Pre-capsulated Dental Amalgam
Document Title [Hindi] : दंत चिकित्सा — पूर्व कैप्सूलयुक्त दंत अमलगम
Document Type : New
Language : English
Priority : 2
ICS Code : 11.060.10
Date of Project Approval : 29-04-2025
Standards to be Superseded :


Classification Details
Group : Medical and Hospital Equipments
Sub Group : Dentistry instruments/equipment and accessories
Sub Sub Group : Filling and restorative materials
Aspects : Product Specification
Risk : Medium
Certification : Voluntary Certification
Short Commom Man's Title :
ITCHS Code :
Ministry :
  • Ministry of Health and Family Welfare - Department of Health and Family Welfare
Sustainable development Goals :
Degree of Equivalence : Identical under dual numbering
Identical/Equivalent Standards : ISO 20749 : 2023
Organization Type: ISO

Sl.No. Synosis Points
1 This document specifies the requirements and test methods for dental amalgam products supplied to the user in capsules, pre-dosed with dental amalgam alloy powder and dental mercury in quantities suitable for the creation of a single dental restoration.
2 This document specifies the requirements and test methods for the capsule and the requirements for packaging and marking.
3 This document is not applicable to other metallic materials in which an alloy powder reacts with an alloy that is liquid at ambient temperature to produce a solid metallic material intended for dental restoration.
4 This document is restricted to dental amalgam products marketed in pre-capsulated form, alone. Other products intended for use in the production of dental amalgam restorations (dental amalgam alloy as a free-flowing powder supplied in bulk masses, dental amalgam alloy powder supplied as compressed tablets and dental mercury sachets) are described in ISO 24234.

Timeline Details


S.No. P-Draft
Completion Date
WC-Draft
Completion Date
Final-Draft
Completion Date
Project
Completion Date(Gazette)
Entered By Entered On
1 29-04-2025 29-08-2025 29-09-2025 29-01-2026 Ms. HARSHADA GANESH KADAM 29-04-2025