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Kerr Endodontics Warm-Bonded Endodontic Obturation System - HSA Registration DE0500440

Access comprehensive regulatory information for Kerr Endodontics Warm-Bonded Endodontic 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 DE0500440 and owned by Kerr Corporation. The device was registered on July 05, 2016.

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
DE0500440
Kerr Endodontics Warm-Bonded Endodontic Obturation System
HSA Registration Number: DE0500440
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Product Description

Devices designed to deliver preheated sealing, filling, and core materials into a root canal for direct warm bonding during an endodontic obturation procedure.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0500440
Registration Date
July 05, 2016
Change Notification Approval Date
March 18, 2024
Retention Due Date
July 04, 2025
Product Owner
Short Name
Kerr Corporation
Address
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)
TF Adaptive Gutta Percha Obturator for use with TF files Size SM2 TF Adaptive Gutta Percha Obturator for use with TF files Size SM3 TF Adaptive Verifiers for use with TF Files (Size SM2) TF Adaptive Verifiers for use with TF Files (Size SM3) TF Adaptive Gutta Percha Obturator for use with TF files Size ML1 TF Adaptive Gutta Percha Obturator for use with TF files Size ML2 TF Adaptive Gutta Percha Obturator for use with TF files Size ML3 TF Adaptive Verifiers for use with TF Files (Size ML1) TF Adaptive Verifiers for use with TF Files (Size ML2) TF Adaptive Verifiers for use with TF Files (Size ML3) TF Adaptive Carrier-Based Obturators Economy Pack Size SM2 TF Adaptive Carrier-Based Obturators Economy Pack Size SM3 TF Adaptive Carrier-Based Obturators Economy Pack Size ML1 TF Adaptive Carrier-Based Obturators Economy Pack Size ML2 TF Adaptive Carrier-Based Obturators Economy Pack Size ML3 Soft-Core Intro Kit Soft-Core Heater Soft-Core Obturator Size #20 Soft-Core Obturator Size #25 Soft-Core Obturator Size #30 Soft-Core Obturator Size #35 Soft-Core Obturator Size #40 Soft-Core Obturator Size #45 Soft-Core Obturator Size #50 Soft-Core Obturator Size #55 Soft-Core Obturator Size #60 Soft-Core Obturator Economy Pack Size #20 Soft-Core Obturator Economy Pack Size #25 Soft-Core Obturator Economy Pack Size #30 Soft-Core Obturator Economy Pack Size #35 Soft-Core Obturator Economy Pack Size #40 Soft-Core Obturator Economy Pack Size #45 Soft-Core Obturator Economy Pack Size #50 Soft-Core Obturator Economy Pack Size #55 Soft-Core Obturator Economy Pack Size #60 Soft-Core Size Verifier #20 Soft-Core Size Verifier #25 Soft-Core Size Verifier #30 Soft-Core Size Verifier #35 Soft-Core Size Verifier #40 Soft-Core Size Verifier #45 Soft-Core Size Verifier #50 Soft-Core Size Verifier #55 Soft-Core Size Verifier #60
Model Identifier(s)
815-1550 815-1551 815-1552 815-1553 815-1554 815-1555 815-1556 815-1557 815-1558 815-1559 815-1560 815-1561 815-1562 815-1563 815-1564 972-3000 972-3002 972-3020 972-3025 972-3030 972-3035 972-3040 972-3045 972-3050 972-3055 972-3060 972-3120 972-3125 972-3130 972-3135 972-3140 972-3145 972-3150 972-3155 972-3160 972-3220 972-3225 972-3230 972-3235 972-3240 972-3245 972-3250 972-3255 972-3260