HSA · registration DE0510508Kerr OptiBond™ Gel Etchant
SingaporeDentalClass BKerr Italia S.r.l.
Official record identity
- Registration number
- DE0510508
- Model name
- Gel Etchant Refill Pack; Gel Etchant Economy Pack
- Model identifier
- 31297; 34632
- Registration date
- March 26, 2025
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Kerr Italia S.r.l.
- Registrant / registration holder
- EHC COMMERCIAL SINGAPORE PTE. LTD.
Official 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.
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.