# K192007: TheraBase, TheraBase Ca

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Mar 17, 2020 after 232 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: 2 generations back to K082449 (2008). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161256: TheraCem, Bisco, Inc. (2016) Summary page 4.

## Indications for use
1. Metal crowns, bridges, inlays, and onlays (includes porcelain-fused-to-metal and composite-to-metal) 2. Porcelain, Ceramic Crowns, inlays, and onlays (includes alumina and zirconia) 3. Resin crowns, bridges, inlays, and onlays (resin-based composite/composite-ceramic hybrid) 4. Metal (prefabricated or cast) and non-metal/fiber endodontic posts 5. Implant supported restorations 6. Orthodontic Appliances (brackets, bands) 7. Lining and basing applications under restorations

Source page: https://510kreport.com/device/K192007
Methodology: https://510kreport.com/methodology