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510(k) Data Aggregation
K Number
K241924Device Name
Elastic Impression Material
Manufacturer
Beijing OKVD Biological Technology Ltd.
Date Cleared
2024-12-27
(179 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
Beijing OKVD Biological Technology Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous, orthodontic and implant impression techniques.
Device Description
The product is a kind of addition-cure silicon rubber impression material composed of vinyl polysiloxane and various fillers with neutral smell and applicable to impression in dentistry. This product is mainly composed of a matrix and a catalyst. The matrix is mainly composed of polydimethylsiloxane, vinyl silicone oil, methyl hydrogen polysiloxane, silica dioxide, ,calcium carbonate, and colorants. The catalyst is mainly composed of polydimethylsiloxane, silica dioxide, calcium carbonate, platinum catalyst, and colorants.
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