# K161256: TheraCem

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Jul 29, 2016 after 86 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: 1 generation back to K082449 (2008). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082449: Biscem Translucent, Model D-45011; Biscem Opaque, Model D-45012, Bisco, Inc. (2008) Summary page 4.

## Most influential descendants
- K192007: TheraBase, TheraBase Ca (2020), 0 descendants of its own

## Indications for use
Use TheraCem to cement the following: 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)

Source page: https://510kreport.com/device/K161256
Methodology: https://510kreport.com/methodology