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HSA · registration DE0510205

Kerr OptiBond™ eXTRa Universal

SingaporeDentalClass BKerr Italia S.r.l.
Verified
Official record identity
Registration number
DE0510205
Model name
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
36658; 36659; 36660; 36661; 36662; 36663
Registration date
January 03, 2025
Classification
Risk class
Class B
Official value: CLASS B
Published category
Dental
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Published parties
Product owner
Kerr Italia S.r.l.
Registrant / registration holder
EHC COMMERCIAL SINGAPORE PTE. LTD.
Official 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.

Additional source fields
Product owner address
Via Passanti, 174, Scafati(SA), 84018, Italy
Registrant address
13 STAMFORD ROAD, #02-11, CAPITOL PIAZZA, Singapore 178905
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.