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Datum Dental OSSIX™ BONE Bone Grafting Material - HSA Registration DE0502446

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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CLASS D
DE0502446
Datum Dental OSSIX™ BONE Bone Grafting Material
HSA Registration Number: DE0502446
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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).

Device 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 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