Singapore HSA registration DE0012075
Botiss Biomaterials Cerabone® Granulate
Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Orthopaedics
Registration information
- Registration Number
- DE0012075
- Registration Date
- January 02, 2013
- Change Notification Approval Date
- October 02, 2023
- Retention Due Date
- January 01, 2026
Product description
cerabone® Granulate is intended for the permanent filling or reconstruction of aseptic bone defects and for volume augmentation in autologous spongiosa transplantation in dental, oral and maxillofacial surgery. Indications: - Alveolar ridge augmentation/reconstruction - Filling of bone defects (including after root resection, apicoectomy or cystectomy) - Filling of extraction alveoli to support alveolar ridge preservation - Sinus lift procedure - Filling of periodontal bone defects - Filling of extraction sockets as part of immediate implantations - Filling of peri-implant bone defects.
Product Owner
- Short Name
- botiss biomaterials GmbH
- Address
- Hauptstraße 28, 15806, Zossen, GERMANY
Registrant
- Address
- 73 UBI ROAD 1, OXLEY BIZHUB, #10-61/62, SINGAPORE 408733
Importer
- Address
- 73 UBI ROAD 1, OXLEY BIZHUB, #10-61/62, SINGAPORE 408733
Model information
- Model Name(s)
- cerabone® Granulate cerabone® Granulate cerabone® Granulate cerabone® Granulate cerabone® Granulate cerabone® Granulate cerabone® Granulate cerabone® Granulate
- Model Identifier(s)
- 1510 1511 1512 1515 1520 1521 1522 1525
About this record
Access comprehensive regulatory information for Botiss Biomaterials Cerabone® Granulate in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0012075 and owned by botiss biomaterials GmbH. The device was registered on January 02, 2013.
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 D