Search Results
Found 1 results
510(k) Data Aggregation
K Number
K250317Device Name
EsFlow PLUS
Manufacturer
Spident CO. LTD
Date Cleared
2025-05-30
(115 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Spident CO. LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Direct restorations
- Base and Liner
- Block out undercut
- Repair of (in)direct aesthetic restorations
- Core build-up
Device Description
EsFlow PLUS is a light-cured radiopaque flowable composite resin used for direct restoration. It has a smooth surface, so it is applied smoothly to the teeth, and has good gloss and aesthetics. In addition, it has high mechanical strength, so it can sufficiently withstand the occlusal force. EsFlow PLUS has two types of viscosities, so it can be applied to various clinical cases. The inorganic filler of EsFlow PLUS has a particle size range of 0.01 to 0.5 μm, and a volume ratio of about 42 to 47% depending on the model.
Ask a Question
Page 1 of 1