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Botiss Biomaterials Cerabone® Granulate - HSA Registration DE0012075

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.

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CLASS D
DE0012075
Botiss Biomaterials Cerabone® Granulate
HSA Registration Number: DE0012075
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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.

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 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