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510(k) Data Aggregation
K Number
K201483Device Name
Impression Material
Manufacturer
Zhengzhou Huaer Electro Optics Technology Co., Ltd
Date Cleared
2020-10-08
(126 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
Zhengzhou Huaer Electro Optics Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Used for all crown, bridge, and orthodontic impression techniques.
Device Description
The Impression Material is a kind of addition-cure rubber impression material composed of vinyl polysiloxane and various fillers, with neutral smell and applicable to impression in dentistry. It consists of base and catalyst, in which putty base contains Vinyl polysiloxane, Methylhydrogensiloxane dimethylsiloxane, dimeticone, white oil and silicon. Catalyst mainly contains vinyl polysiloxane, platinum catalyst, dimeticone, white oil and silicon. The product is provided non-sterile.
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