HSA · registration DE0506010Nobel Biocare On1 Temporary Abutments
- Registration number
- DE0506010
- Model name
- 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
- 38701; 38702; 38703; 38704; 38705; 38706
- Registration date
- July 26, 2021
- Source update date
- December 10, 2024
- Risk class
- Class C
- Product owner
- Nobel Biocare AB
- Registrant / registration holder
- EHC COMMERCIAL SINGAPORE PTE. LTD.
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 address
- PO Box 5190, SE-402 26, Västra Hamngatan 1, Göteborg, 411 17, Sweden
- Registrant address
- 13 STAMFORD ROAD, #02-11, CAPITOL PIAZZA, Singapore 178905
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.