Singapore HSA registration DE0502446
Datum Dental OSSIX™ BONE Bone Grafting Material
Singapore·CLASS D·Datum Dental Ltd.·Registered December 14, 2018Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Dental
Registration information
- Registration Number
- DE0502446
- Registration Date
- December 14, 2018
- Change Notification Approval Date
- March 25, 2025
- Retention Due Date
- December 13, 2025
Product description
OSSIX™ BONE is intended for the following uses: • Augmentation or reconstructive treatment of the alveolar ridge; • Filling of periodontal defects; • Filling of defects after root resection, apicoectomy and cystectomy; • Filling of extraction sockets to enhance preservation of the alveolar ridge; • Elevation of the maxillary sinus floor; • Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); • Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
Product Owner
- Short Name
- Datum Dental Ltd.
- Address
- 38 Hayarkon St., 8122741 Yavne, ISRAEL
Registrant
- Address
- 1 WALLICH STREET, GUOCO TOWER, #18-02, SINGAPORE 078881
Importer
- Address
- 1 IRVING PLACE, THE COMMERZE@IRVING, #05-08, SINGAPORE 369546 1 WALLICH STREET, GUOCO TOWER, #18-02, SINGAPORE 078881
Model information
- Model Name(s)
- OSSIX™ Bone OSSIX™ Bone OSSIX™ Bone
- Model Identifier(s)
- OXB0125 OXB0250 OXB0500
About this record
Access comprehensive regulatory information for Datum Dental OSSIX™ BONE Bone Grafting Material in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0502446 and owned by Datum Dental Ltd.. The device was registered on December 14, 2018.
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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