Analysis for Key Points of Registration Applications and Difficulties of Process Control of 3D Printed Customized Dentures.
10.3969/j.issn.1671-7104.2023.05.017
- Author:
Zhijun REN
1
;
Ran CHEN
1
;
Zhicheng HUANG
1
Author Information
1. Beijing Center for Medical Device Evaluation and Inspection, Beijing,
- Publication Type:Journal Article
- Keywords:
3D printing denture;
key process verification;
medical devices registration;
product performance research;
quality management system
- From:
Chinese Journal of Medical Instrumentation
2023;47(5):557-561
- CountryChina
- Language:Chinese
-
Abstract:
With the highlighted advantages of 3D printing technology in the field of dental prosthodontics, there is increasing in the numbers of registration applications for additive manufacturing customized dentures. However, there is still a lack of unified analysis in the core elements of process control, the key points of registration and the safety production quality control. Based on the current research status of the industry, the study is intended to clarify confusion and difficulties, deeply analyse the mechanism of the product defects, sort the core elements of process control, then try to establish a systematic evaluation system from product performance research, key process verification, production quality control and the description of registration files, so that it can provide help for practitioners to clarify research direction, establishing quality management system, improving the efficiency of registration and ensuring product quality.
