Singapore HSA registration DE0510468
Orthocell Striate+
Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Dental
Registration information
- Registration Number
- DE0510468
- Registration Date
- March 14, 2025
- Retention Due Date
- March 13, 2026
Product description
Striate+™ is a sterile, resorbable collagen barrier membrane intended for use in guided bone and guided tissue regeneration. Striate+™ is indicated for use in: • Augmentation around implants placed in immediate extraction sockets • Augmentation around implants placed in delayed extraction sockets • Localized ridge augmentation for later implantation • Alveolar ridge reconstruction for prosthetic treatment • Filling of bone defects after root resection, cystectomy, removal of retained teeth • Guided bone regeneration in dehiscence defects; and • Guided tissue regeneration procedures in periodontal defects.
Product Owner
- Name
- Orthocell Ltd.
- Short Name
- Orthocell Ltd.
- Address
- Building 191, Murdoch University South Street, Murdoch WA 6150, AUSTRALIA
Registrant
- Address
- 116 CHANGI ROAD, WIS@CHANGI, #04-05, SINGAPORE 419718
Importer
- Address
- 9 RAFFLES PLACE, REPUBLIC PLAZA, #26-01, SINGAPORE 048619
Model information
- Model Name(s)
- Striate+ Striate+ Striate+
- Model Identifier(s)
- OCG-152 OCG-203 OCG-304
About this record
Access comprehensive regulatory information for Orthocell Striate+ in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0510468 and owned by Orthocell Ltd.. The device was registered on March 14, 2025.
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