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Singapore HSA registration DE0510205

Kerr OptiBond™ eXTRa Universal

Singapore flagSingapore·CLASS B·Kerr Italia S.r.l.·Registered January 03, 2025
Device classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration information
Registration Number
DE0510205
Registration Date
January 03, 2025
Retention Due Date
January 02, 2026
Product description
OptiBond eXTRa 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 to bond core build-ups and to seal hypersensitive and /or exposed root surfaces.
Product Owner
Name
Kerr Italia S.r.l.
Short Name
Kerr Italia S.r.l.
Address
Via Passanti, 174, Scafati(SA), 84018, ITALY
Registrant
Name
EHC Commercial Singapore Pte. Ltd.
Address
7500A BEACH ROAD, THE PLAZA, #09-308, SINGAPORE 199591
Importer
Name
EHC COMMERCIAL SINGAPORE PTE. LTD. EHC SUPPLY
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 eXTRa Universal Bottle Kit OptiBond eXTRa Universal Unidose Kit OptiBond eXTRa Universal Bottle Refill - Primer OptiBond eXTRa Universal Bottle Refill - Adhesive OptiBond eXTRa Universal Sample Kit OptiBond eXTRa Universal Bottle Sample Kit
Model Identifier(s)
36658 36659 36660 36661 36662 36663
About this record

Access comprehensive regulatory information for Kerr OptiBond™ eXTRa 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 DE0510205 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B