# K210259: Parkell Self-Adhesive Cement

- Pathway: 510(k) (Traditional)
- Applicant: Parkell, Inc.
- Decided: Jan 20, 2022 after 353 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K900510 (1990). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073173: Self-Adhesive Resin Cement, Dentsply Interntional (2008) Summary page 4.

## Most influential descendants
- K253337: REGEN Bioactive Cement (2026), 0 descendants of its own

## Indications for use
Parkell Self-Adhesive Cement is intended for the cementation of indirect restoratives including ceramic, zirconia, composite, and metal-based inlays, onlays, crowns, bridges, and posts.

Source page: https://510kreport.com/device/K210259
Methodology: https://510kreport.com/methodology