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Kerr SonicFill 2 SingleFill Composite System - HSA Registration DE0019213

Access comprehensive regulatory information for Kerr SonicFill 2 SingleFill Composite System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0019213 and owned by Kerr Corporation. The device was registered on April 28, 2017.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0019213
Kerr SonicFill 2 SingleFill Composite System
HSA Registration Number: DE0019213
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Product Description

SonicFill 2 is indicated for direct placement in all cavity classes in anterior and posterior teeth. Additional indications include: base/liner material, repair of enamel defects, repair of provisionals, repair of porcelain restorations, minor occlusal build-ups, pit and fissure sealant, luting of composite/ceramic veneers, core buildups and incisal abrasions.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0019213
Registration Date
April 28, 2017
Retention Due Date
April 27, 2026
Product Owner
Short Name
Kerr Corporation
Address
also trading as Pentron Clinical, 1717 West Collins Avenue, Orange California 92867, UNITED STATES
Registrant
Address
7500A BEACH ROAD, THE PLAZA, #09-303, SINGAPORE 199591
Importer
Address
13 STAMFORD ROAD, CAPITOL PIAZZA, #02-11, SINGAPORE 178905
Model Information
Model Name(s)
SonicFill Multiflex Coupling 35314 SonicFill Handpiece SonicFill 2 Single-Fill Composite Value Kit SonicFill 2 Single-Fill Composite Intro Kit SonicFill 2 SingleFill Composite system - Composite Material Refill SonicFill 2 SingleFill Composite system - Composite Material Refill SonicFill 2 SingleFill Composite system - Composite Material Refill SonicFill 2 SingleFill Composite system - Composite Material Refill
Model Identifier(s)
35134 (1.008.0581) 35215 36043 36044 36051 36052 36053 36054