# K223477: PMMA Blocks for Dental Use

- Pathway: 510(k) (Traditional)
- Applicant: Aidite (Qinhuangdao) Technology Co., Ltd.
- Decided: Feb 16, 2023 after 90 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K070991 (2007). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190217: Aidite PMMA, Aidite (Qinhuangdao) Technology Co., Ltd. (2020) Summary page 4.

## Indications for use
The device is made from PMMA (polymethylmethacrylate) for the fabrication of temporary crowns and bridges and is intended for use in the oral cavity for up to six (6) months while awaiting a permanent restoration. Restorations are designed and manufactured by a dental Professional (Technician) using CAD technology.

Source page: https://510kreport.com/device/K223477
Methodology: https://510kreport.com/methodology