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Nobel Biocare On1 Clinical and Prosthetic Screw - HSA Registration DE0505953

Access comprehensive regulatory information for Nobel Biocare On1 Clinical and Prosthetic Screw in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505953 and owned by Nobel Biocare AB. The device was registered on July 01, 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
DE0505953
Nobel Biocare On1 Clinical and Prosthetic Screw
HSA Registration Number: DE0505953
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Product Description

The On1 Clinical Screw is designed to fix the On1 Base or On1 Base Xeal to an endosseous dental implant.The On1 Prosthetic Screw is designed to fix the On1 abutments to an On1 Base or On1 Base Xeal.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0505953
Registration Date
July 01, 2021
Change Notification Approval Date
December 10, 2024
Retention Due Date
June 30, 2025
Product Owner
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 Clinical Screw 1.75 mm NP On1 Clinical Screw 2.5 mm NP On1 Clinical Screw 1.75 mm RP On1 Clinical Screw 2.5 mm RP On1 Clinical Screw 1.75 mm WP On1 Clinical Screw 2.5 mm WP On1 Prosthetic Screw NP/RP/WP
Model Identifier(s)
38744 38745 38746 38747 38748 38749 38750