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510(k) Data Aggregation
K Number
K013993Device Name
NEOCALEX
Manufacturer
Date Cleared
2002-02-22
(80 days)
Regulation Number
872.4565Why did this record match?
Applicant Name (Manufacturer) :
STEPHEN M KORAL, DMD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Neocalex is indicated for the following uses in dentistry:
1. root canal filling
2. apexification
3. direct pulp cap
4. indirect pulp cap
Device Description
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