HSA · registration DE0505324Kerr SimpliShade™ Universal Nanohybrid Restorative Composite
SingaporeDentalClass BKerr Corporation
Official record identity
- Registration number
- DE0505324
- Model name
- SimpliShade Syringe, Light; SimpliShade Syringe, Medium; SimpliShade Syringe, Dark; SimpliShade Syringe, Bleach White; SimpliShade Syringe, Universal Opaque; SimpliShade Unidose 20 Pack, Light; SimpliShade Unidose 20 Pack, Medium; SimpliShade Unidose 10 Pack, Dark; SimpliShade Unidose 10 Pack, Bleach White; SimpliShade Unidose 10 Pack, Universal Opaque; SimpliShade Sample Syringe, Light; SimpliShade Sample Syringe, Medium; SimpliShade Sample Unidose 5 Pack (2 Light, 2 Medium, 1 Dark)
- Model identifier
- 36971; 36972; 36973; 36974; 36975; 36976; 36977; 36978; 36979; 36980; 36981; 36982; 36983
- Registration date
- January 08, 2021
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Kerr Corporation
- Registrant / registration holder
- EHC COMMERCIAL SINGAPORE PTE. LTD.
Official description
SimpliShade, a nanohybrid dental restorative, is indicated for direct placement in all cavity classes in anterior and posterior teeth. Additional indications include: repair of porcelain/composite restorations, and core build-ups.
Additional source fields
- Product owner address
- 1717 West Collins Avenue, Orange, California 92867, United States
- 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.