Singapore HSA registration DE0510508
Kerr OptiBond™ Gel Etchant
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 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.
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
About this record
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 DatabasePowered by Pure Global AIHSA Official DataCLASS B