# K253337: REGEN Bioactive Cement

- Pathway: 510(k) (Traditional)
- Applicant: Inter-Med, Inc.
- Decided: Apr 15, 2026 after 197 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: 6 generations back to K900510 (1990). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210259: Parkell Self-Adhesive Cement, Parkell, Inc. (2022) Summary page 5.

## Indications for use
Designed for luting of indirect restorations (inlays, onlays, crowns, bridges, and endodontic posts) made of metal alloys, composite resins, porcelain, lithium disilicate or zirconia.

Source page: https://510kreport.com/device/K253337
Methodology: https://510kreport.com/methodology