Singapore HSA registration DE0505659
Nobel Biocare On1 Abutments
Singapore·CLASS C·Nobel Biocare AB·Registered April 16, 2021Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Dental
Registration information
- Registration Number
- DE0505659
- Registration Date
- April 16, 2021
- Change Notification Approval Date
- October 22, 2024
- Retention Due Date
- April 15, 2026
Product description
The On1 Universal Abutment is indicated to support the placement of single unit,screw-retained prosthetic restorations in the maxilla or mandible. The On1 Universal Abutment Non-Engaging is indicated to support the placement of multiple unit, screw-retained prosthetic restorations in the maxilla or mandible for implants with less than 20° overall divergences to allow path of insertion. The On1 Esthetic Abutment is indicated to support the placement of single unit and multiple unit, cement-retained prosthetic restorations in the maxilla or mandible.
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 Universal Abutment Non-Engaging NP 0.3mm On1 Universal Abutment Non-Engaging NP 1.25mm On1 Universal Abutment Non-Engaging RP 0.3mm On1 Universal Abutment Non-Engaging RP 1.25mm On1 Universal Abutment Non-Engaging WP 0.3mm On1 Universal Abutment Non-Engaging WP 1.25mm On1 Universal Abutment 0.3 mm NP On1 Universal Abutment 1.25 mm NP On1 Universal Abutment 0.3 mm RP On1 Universal Abutment 1.25 mm RP On1 Universal Abutment 0.3 mm WP On1 Universal Abutment 1.25 mm WP On1 Esthetic Abutment Titanium 0.3 mm NP On1 Esthetic Abutment Titanium 0.3 mm RP On1 Esthetic Abutment Titanium 0.3 mm WP
- Model Identifier(s)
- 300361 300362 300363 300364 300365 300366 38707 38708 38709 38710 38711 38712 38713 38714 38715
About this record
Access comprehensive regulatory information for Nobel Biocare On1 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 DE0505659 and owned by Nobel Biocare AB. The device was registered on April 16, 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C