Singapore HSA registration DE0506010
Nobel Biocare On1 Temporary Abutments
Singapore·CLASS C·Nobel Biocare AB·Registered July 26, 2021Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Dental
Registration information
- Registration Number
- DE0506010
- Registration Date
- July 26, 2021
- Change Notification Approval Date
- December 10, 2024
- Retention Due Date
- July 25, 2025
Product description
Intended to be connected to an endosseous dental implant to support the placement of a dental prosthesis. The On1™ Temporary Abutment Engaging is indicated for use with single unit, screw-retained temporary dental prosthesis placed on the On1™ Base or On1 Base Xeal™ in the maxilla or mandible, for up to 180 days. The On1™ Temporary Abutment Non-Engaging is indicated for use with multiple unit, screw-retained temporary dental prosthesis placed on the On1™ Base or On1 Base Xeal™ in the maxilla or mandible, for up to 180 days.
Product Owner
- Name
- Nobel Biocare AB
- Short Name
- Nobel Biocare AB
- Address
- PO Box 5190, SE-402 26, Västra Hamngatan 1, Göteborg, 411 17, SWEDEN
Registrant
- Address
- 7500A BEACH ROAD, THE PLAZA, #09-308, SINGAPORE 199591
Importer
- Address
- 13 STAMFORD ROAD, CAPITOL PIAZZA, #02-11, SINGAPORE 178905 13 STAMFORD ROAD, CAPITOL PIAZZA, #02-11, SINGAPORE 178905 73 UBI ROAD 1, OXLEY BIZHUB, #10-61/62, SINGAPORE 408733
Model information
- Model Name(s)
- On1 Temporary Abutment Engaging NP On1 Temporary Abutment Non-Engaging NP On1 Temporary Abutment Engaging RP On1 Temporary Abutment Non-Engaging RP On1 Temporary Abutment Engaging WP On1 Temporary Abutment Non-Engaging WP
- Model Identifier(s)
- 38701 38702 38703 38704 38705 38706
About this record
Access comprehensive regulatory information for Nobel Biocare On1 Temporary Abutments in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0506010 and owned by Nobel Biocare AB. The device was registered on July 26, 2021.
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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