meddevicedb.com FDA Device Reference

PMMA Blocks for Dental Use

K223477 Class II Traditional
Decision Date
2023-02-16
Sponsor / Applicant
Aidite (Qinhuangdao) Technology Co., Ltd.

Technical Specification

510(k) Submission ID K223477
Product Code EBG
Medical Specialty / Panel Dental
Regulation Citation 21 CFR 872.3770
Decision Date 2023-02-16
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

PMMA Blocks for Dental Use received FDA 510(k) clearance under submission number K223477, sponsored by Aidite (Qinhuangdao) Technology Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2023-02-16.

Classification & Regulation

This clearance is catalogued under FDA product code EBG and 21 CFR 872.3770, within the Dental review panel as a Class II device.