| ISO 28319 Second edition 2018-04 Dentistry - Laser welding and filler materials |
| Recognition Number | Dental/ENT |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 4-247 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Dental/ENT |
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This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| Regulation Number | Device Name | Device Class | Product Code |
| §872.3710 | Alloy, Metal, Base | Class 2 | EJH |
| §872.3060 | Alloy, Gold-Based Noble Metal | Class 2 | EJT |
| §872.3060 | Alloy, Other Noble Metal | Class 2 | EJS |
| 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. |