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Kerr OptiBond™ Universal - HSA Registration DE0510206

Access comprehensive regulatory information for Kerr OptiBond™ Universal in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510206 and owned by Kerr Italia S.r.l.. The device was registered on January 03, 2025.

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
DE0510206
Kerr OptiBond™ Universal
HSA Registration Number: DE0510206
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Product Description

OptiBond Universal is an adhesive resin used to bond the tooth to various restorative materials such as composites, ceramics, metals, and endodontic posts. It is also be used for cavity sealing as a pre-treatment for indirect restorations.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0510206
Registration Date
January 03, 2025
Retention Due Date
January 02, 2026
Product Owner
Short Name
Kerr Italia S.r.l.
Address
Via Passanti, 174, Scafati(SA), 84018, ITALY
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)
OptiBond Universal – 5ml Bottle Refill OptiBond Universal – Unidose Sample Pack
Model Identifier(s)
36519 36641