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HSA · registration DE0505659

Nobel Biocare On1 Abutments

SingaporeDentalClass CNobel Biocare AB
Verified
Official record identity
Registration number
DE0505659
Model name
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
300361; 300362; 300363; 300364; 300365; 300366; 38707; 38708; 38709; 38710; 38711; 38712; 38713; 38714; 38715
Registration date
April 16, 2021
Source update date
October 22, 2024
Classification
Risk class
Class C
Official value: CLASS C
Published category
Dental
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Published parties
Product owner
Nobel Biocare AB
Registrant / registration holder
EHC COMMERCIAL SINGAPORE PTE. LTD.
Official 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.

Additional source fields
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
About this record

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.