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510(k) Data Aggregation
K Number
K143382Device Name
DentiAnn Smart Sil
Manufacturer
Date Cleared
2015-02-23
(90 days)
Product Code
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
SeilGlobal Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
DentiAnn Light-body is to be used as a light body material for:
- Two step putty/wash technique
- · Single step putty/wash technique
- Functional peripheries
- Reline impressions
- = Crown/bridge work
- Inlays, Onlays
DentiAnn Heavy-body is to be used as a heavy body material for:
- · Two step putty/wash technique
- · Single step putty/wash technique
- · Functional peripheries
- Crown/bridge work
- Inlays, Onlays
SmartSil-Putty is to be used as a preliminary material for:
- · Two step putty/wash technique
- · Single step putty/wash technique
- · Functional peripheries
- Crown/bridge work
- · Inlays, Onlays
SmartSil-Bite is to be used as a light body material for:
- = Making accurate occlusal registrations
- Standards bite registrations in the end bite position.
- · Key material for needle point registration.
- · Production of small model segments
Device Description
DentiAnn Smart Sil is a two component (base paste and catalyst, mixing ratio 1:1) vinyl polysiloxane impression material to be used for impressions, where typically alginates are used. The DentiAnn Smart Sil offers four different viscosities (light, heavy, putty and bite) in delivery systems of cartridges, tubes and/or jars. The device includes accessories such as a mixing tip and a spoon.
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