Search Results
Found 1 results
510(k) Data Aggregation
K Number
K162661Device Name
SavDenTM MTA Root Canal Filling Materials
Manufacturer
Date Cleared
2017-04-25
(211 days)
Product Code
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
tYDS Biotech Incorporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
- A root end filling material.
- For the repair of root canals as an apical plug during apexification.
- For repair of root perforations during root canal therapy or as a consequence of internal resorption.
- As a pulp capping material.
- Pulpotomy of primary teeth in the child (ages >2-12 years) and adolescent (ages >12-21 years) pediatric patient populations.
Device Description
SavDen™ MTA powder consists of fine, hydrophilic particles that set in the presence of water. Hydration of the powder creates a colloidal gel that is solidified to form an impermeable barrier that fully cures over a four-week period.
Ask a Question
Ask a specific question about this device
Page 1 of 1