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Kerr Endodontics elements IC Obturation System - HSA Registration DE0504181

Access comprehensive regulatory information for Kerr Endodontics elements IC Obturation 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 DE0504181 and owned by Kerr Corporation. The device was registered on February 28, 2020.

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
DE0504181
Kerr Endodontics elements IC Obturation System
HSA Registration Number: DE0504181
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Product Description

The cordless elements IC obturation system is intended to be used in Endodontics to backfill and downpack gutta-percha during root canal obturation using warm vertical obturation technique

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0504181
Registration Date
February 28, 2020
Change Notification Approval Date
March 09, 2022
Retention Due Date
February 27, 2026
Product Owner
Short Name
Kerr Corporation
Address
1717 West Collins Avenue, Orange, California 92867, UNITED STATES
Registrant
Address
7500A BEACH ROAD, THE PLAZA, #09-308, SINGAPORE 199591
Importer
Address
13 STAMFORD ROAD, CAPITOL PIAZZA, #02-11, SINGAPORE 178905 13 STAMFORD ROAD, CAPITOL PIAZZA, #02-11, SINGAPORE 178905
Model Information
Model Name(s)
elements™ IC Obturation System elements™ IC Oburation System elements™ IC Oburation System elements™ IC Downpack elements™ IC Downpack elements™ IC Downpack elements™ IC Backfill elements™ IC Backfill elements™ IC Backfill elements™ IC Dual Charger elements™ IC Single Charger
Model Identifier(s)
973-0600-TYPE B 973-0600-TYPEF 973-0600-TYPEG 973-0602-TYPE B 973-0602-TYPEF 973-0602-TYPEG 973-0604-TYPE B 973-0604-TYPEF 973-0604-TYPEG 973-0610 973-0612