# K143292: TheraCal DC

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Aug 4, 2015 after 260 days
- Product code: EJK (Liner, Cavity, Calcium Hydroxide)
- Device class: 2
- Regulation: 21 CFR 872.3250
- 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 K922721 (1992). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063237: Theracal LC, Bisco, Inc. (2006) Summary page 4.

## Most influential descendants
- K180344: TheraCal DC (2018), 1 descendant of its own
- K211905: UltraCal XS (2021), 0 descendants of its own

## Indications for use
TheraCal DC is indicated for use for: 1. Pulpotomy 2. Temporary filling material 3. Repair of root perforations 4. Repair of furcation perforations 5. Repair of perforating internal and external resorptions 6. Root-end filling in endodontic surgery 7. Pulp exposures (direct pulp capping) 8. Protective liner (Indirect Pulp Capping) and Base for use under a variety of substrates

Source page: https://510kreport.com/device/K143292
Methodology: https://510kreport.com/methodology