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510(k) Data Aggregation
K Number
K143292Device Name
TheraCal DC
Manufacturer
Bisco Inc
Date Cleared
2015-08-04
(260 days)
Product Code
EJK, CLA
Regulation Number
872.3250Why did this record match?
Applicant Name (Manufacturer) :
Bisco Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TheraCal DC is indicated for use for:
- 1. Pulpotomy
- 2. Temporary filling material
- 3. Repair of root perforations
- Repair of furcation perforations 4.
- 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
Device Description
TheraCal DC is a biocompatible, dual-cured, resin-modified calcium silicate that is used to treat damaged dentin in both the crown and the root. TheraCal DC's precise placement allows its use in all deep cavity preparations and endodontic repairs. The dual-cure set permits immediate placement and condensation of the restorative material. Its proprietary formulation allows for a command set with a light curing unit while maintaining ease of placement due to its thixotropic properties.
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