Pure Global

Kerr OptiBond™ Gel Etchant - HSA Registration DE0510508

Access comprehensive regulatory information for Kerr OptiBond™ Gel Etchant in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510508 and owned by Kerr Italia S.r.l.. The device was registered on March 26, 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 Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0510508
Kerr OptiBond™ Gel Etchant
HSA Registration Number: DE0510508
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

Intended Use: Dentin and enamel etching to prepare the tooth surface for the application of a bonding agent. Indications for Use: Tooth surface preparation for application of an adhesive restoration.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0510508
Registration Date
March 26, 2025
Retention Due Date
March 25, 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)
Gel Etchant Refill Pack Gel Etchant Economy Pack
Model Identifier(s)
31297 34632