# K180344: TheraCal DC

- Pathway: 510(k) (Special)
- Applicant: Bisco, Inc.
- Decided: Apr 5, 2018 after 56 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: 3 generations back to K922721 (1992). 3 ancestors in all.
1 later device descends 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)
- K143292: TheraCal DC, Bisco, Inc. (2015) Summary page 4.

## Most influential descendants
- K211905: UltraCal XS (2021), 0 descendants of its own

## Indications for use
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/K180344
Methodology: https://510kreport.com/methodology