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Nobel Biocare On1 Abutments - HSA Registration DE0505659

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.

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CLASS C
DE0505659
Nobel Biocare On1 Abutments
HSA Registration Number: DE0505659
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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 20ยฐ 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.

Device 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 Owner
Short Name
Nobel Biocare AB
Address
PO Box 5190, SE-402 26, Vรคstra Hamngatan 1, Gรถteborg, 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