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Nobel Biocare Nobel Zygoma - HSA Registration DE0019521

Access comprehensive regulatory information for Nobel Biocare Nobel Zygoma in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0019521 and owned by Nobel Biocare AB. The device was registered on August 22, 2017.

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
DE0019521
Nobel Biocare Nobel Zygoma
HSA Registration Number: DE0019521
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Product Description

Zygoma Implant System is intended to be used in the upper jaw arch (osseointegration) for anchoring or supporting prosthetic devices such as tooth replacements to restore chewing function.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0019521
Registration Date
August 22, 2017
Change Notification Approval Date
December 12, 2023
Retention Due Date
August 21, 2025
Product Owner
Short Name
Nobel Biocare AB
Address
PO Box 5190, 402 26, Västra Hamngatan 1, 411 17 Göteborg, SWEDEN
Registrant
Address
7500A BEACH ROAD, THE PLAZA, #09-303, SINGAPORE 199591
Importer
Address
73 UBI ROAD 1, OXLEY BIZHUB, #10-61/62, SINGAPORE 408733
Model Information
Model Name(s)
Connection to Handpiece Implant Driver Bmk Syst RP 21 mm Implant Driver Bmk Syst RP 26 mm Implant Driver Bmk Syst RP 34 mm Healing Abutment Bmk Syst RP Ø5x3 mm Healing Abutment Bmk Syst RP Ø5x5 mm Screwdriver Manual UniGrip 28 mm Screwdriver Machine UniGrip 25 mm Zygoma Surgical Kit Bmk Syst Zygoma 17° Multi-unit Abut 2mm Bmk Syst Zygoma 17° Multi-unit Abut 3mm Bmk Syst Zygoma Multi-unit Abut 3mm Bmk Syst Zygoma Multi-unit Abut 5mm Bmk Syst Zygoma Healing Abutment Ø4x3mm Bmk Syst Zygoma Healing Abutment Ø4x5mm Bmk Syst Zygoma Implant Cover Screw Bmk Syst Zygoma Twist Drill 2.9 mm Bmk Syst Zygoma Twist Drill 2.9 mm short Bmk Syst Zygoma Pilot Drill 3.5 mm Bmk Syst Zygoma Twist Drill 3.5 mm Bmk Syst Zygoma Twist Drill 3.5 mm short Bmk Syst Zygoma Pilot Drill 3.5 mm short Bmk Syst Zyg Impr Cop Open Tray Ø4mm Bmk Syst Zygoma Abutment Screw Bmk Syst Zygoma Healing Abutment Ø4x3mm Bmk Syst Zygoma Healing Abutment Ø4x5mm 45° Multi-unit Abutment Ext Hex RP 6mm 45° Multi-unit Abutment Ext Hex RP 8mm 45° Multi-unit Abutment Ext Hex RP 10mm NobelZygoma 0° Twist Drill 2.9mm NobelZygoma 0° Twist Drill 2.9mm Short NobelZygoma 0° Twist Drill 3.5mm NobelZygoma 0° Twist Drill 3.5mm Short NobelZygoma 0° Twist Drill 4.0mm NobelZygoma 0° Twist Drill 4.0mm Short NobelZygoma 0° Twist Drill 4.4mm NobelZygoma 0° Twist Drill 4.4mm Short 60° Multi-unit Abutment Ext Hex RP 6mm 60° Multi-unit Abutment Ext Hex RP 8mm Zygoma Handle Zygoma Drill Guard Zygoma Drill Guard Short Zygoma Depth Indicator Straight Zygoma Depth Indicator Angled NobelZygoma 0° 30mm NobelZygoma 0° 35mm NobelZygoma 0° 37.5mm NobelZygoma 0° 40mm NobelZygoma 0° 42.5mm NobelZygoma 0° 45mm NobelZygoma 0° 47.5mm NobelZygoma 0° 50mm NobelZygoma 45° 30mm NobelZygoma 45° 32.5mm NobelZygoma 45° 35mm NobelZygoma 45° 37.5mm NobelZygoma 45° 40mm NobelZygoma 45° 42.5mm NobelZygoma 45° 45mm NobelZygoma 45° 47.5mm NobelZygoma 45° 50mm NobelZygoma 45° 52.5mm NobelZygoma 0° Angled MUA Screw Brånemark Sys Zygoma Angled MUA Screw Impr Coping Open Tray Multi-Unit plus Impr Coping Closed Tray Multi-unit Plus Brånemark System® Zygoma Round Bur Cover Screw Driver Bmk Syst Hexagon
Model Identifier(s)
29081 29129 29130 29131 29137 29139 29149 29152 29162 32328 32329 32330 32331 32332 32333 32424 32628 32629 32630 32631 32632 32791 33396 33397 33445 33446 37624 37625 37626 37766 37767 37768 37769 37770 37771 37772 37773 37774 37775 37786 37787 37788 37789 37790 38275 38276 38277 38278 38279 38280 38281 38282 38283 38284 38285 38286 38287 38288 38289 38290 38291 38292 38615 38621 38923 38924 DIA 578-0 DIB 097-0