Pure Global

Southern Implants Zygomatic Implant System - HSA Registration DE0509641

Access comprehensive regulatory information for Southern Implants Zygomatic Implant System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509641 and owned by Southern Implants (PTY) LTD. The device was registered on August 08, 2024.

This page provides complete registration details including product owner information, registrant details, 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
DE0509641
Southern Implants Zygomatic Implant System
HSA Registration Number: DE0509641
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Product Description

The Zygomatic implants are intended to treat partially or fully edentulous patients with severely resorbed or absent maxillae for whom conventional implants are not an option as a means of fixing a permanent or removable dental or maxillofacial prosthesis. The Southern Implants Zygomatic standard implant, the ZYGAN (narrow apex), the Oncology and the ZYGEX (narrow apex) implants are intended to be implanted in the upper jaw to provide support for fixed or removable dental prostheses in patients with partially or fully edentulous maxilla. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading. This implant system is not intended, nor should it be used, in conjunction with an angled abutment. These implants are not intended for single unit loading.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0509641
Registration Date
August 08, 2024
Change Notification Approval Date
December 17, 2024
Retention Due Date
August 07, 2025
Product Owner
Short Name
Southern Implants (PTY) LTD
Address
1 Albert Rd, Irene, 0062, SOUTH AFRICA
Registrant
Address
116 CHANGI ROAD, WIS@CHANGI, #04-05, SINGAPORE 419718
Model Information
Model Name(s)
Compact Conical Abutment for Ø4.0 Ex Hex, Z-Series, Ø4.8 x 1.5mm Compact Conical Abutment for Ø4.0 Ex Hex, Z-Series, Ø4.8 x 2mm Compact Conical Abutment for Ø4.0 Ex Hex, Z-Series, Ø4.8 x 3mm Compact Conical Abutment for Ø4.0 Ex Hex, Z-Series, Ø4.8 x 4mm Compact Conical Abutment for Ø4.0 Ex Hex, Z-Series, Ø4.8 x 5.5mm Hexed Brass Screw, M1.4, Ø2.25mm Head Hexed Brass Screw for Ext. Hex, M2, Ø2.7mm Head Hexed Brass Screw for Ext. Hex, M2, Ø2.4mm Head Slotted Brass Screw, M1.4, Ø2.25mm Head Slotted Brass Screw, M1.4 Long, Ø2.25mm Head Slotted Brass Screw for Ext. Hex, M2, Ø2.7mm Head Slotted Brass Screw for Ext. Hex, M2, Ø2.4mm Head Transfer Impression Coping for Ø4.0 Ex Hex Transfer Impression Coping for Ø4.0 Ex Hex, Wide Pick-Up Impression Coping for Ø4.0 Ex Hex Pick-Up Impression Coping for Ø4.0 Ex Hex, Wide Instrument, Zygomatic Z Depth Gauge Scanning Abutment, Non-Engaging, for Ø4.0 Ex Hex Screw for Impression Coping, Compact Conical, M1.4 Transfer Impression Coping for Ø4.8 Compact Conical Abutment Pick-Up Impression Coping for Ø4.8 Compact Conical Transfer Impression Coping for Ø4.8 Compact Conical Transfer Impression Coping for Ø4.8 Compact Conical, Long Twist Drill, Ø3.5 x 15mm Spade Drill for Zygomatic Twist Drill for Zygomatic, Ø2.7mm Twist Drill for Zygomatic, Short, Ø2.7mm Ø2.7mm Zygomatic Spade Twist Drill, Guided Surgery, Long Ø2.7mm Zygomatic Spade Twist Drill, Guided Surgery, Medium Twist Drill for Zygomatic, Ø2.9mm Twist Drill for Zygomatic, Short, Ø2.9mm Twist Drill for Zygomatic, Ø3.4mm Twist Drill for Zygomatic, Short, Ø3.4mm Multi-Use Twist Drill for Zygomatic, Ø2.7mm, Stainless Steel Multi-Use Twist Drill for Zygomatic, Short, Ø2.7mm, Stainless Steel Multi-Use Twist Drill for Zygomatic, Ø2.9mm, Stainless Steel Multi-Use Twist Drill for Zygomatic, Short, Ø2.9mm, Stainless Steel Counterbore for Zygomatic, Ø2.4 - Ø3.4mm Counterbore for Zygomatic, Short, Ø2.4 - Ø3.4mm Round Burr for Zygomatic, Ø2.9mm Gold Abutment, Engaging, for Ø4.0 Ex Hex Gold Abutment, Non-Engaging, for Ø4.0 Ex Hex Gold Abutment for Ø4.8 Compact Conical, 1mm Cuff Hexed Gold Screw, M1.4, Ø2.25mm Head Quad Gold Screw for Ext. Hex, M2, Ø2.7mm Head Quad Gold Screw for Ext. Hex, M2, Ø2.4mm Head Quad Gold Screw for Ext. Hex, Z-Series M2, Ø2.7mm Head Quad Gold Screw for Ext. Hex, Z-Series M2, Ø2.4mm Head Slotted Gold Screw, M1.4, Ø2.25mm Head Slotted Gold Screw for Ext. Hex, M2, Ø2.7mm Head Slotted Gold Screw for Ext. Hex, M2 Long, Ø2.7mm Head Slotted Gold Screw for Ext. Hex, M2, Ø2.4mm Head Slotted Gold Screw for Ext. Hex, M2 Long, Ø2.4mm Head Slotted Gold Screw for Ext. Hex, Z-Series M2, Ø2.7mm Head Slotted Gold Screw for Ext. Hex, Z-Series M2, Ø2.4mm Head Unigrip Gold Screw, M1.4, Ø2.25mm Head Unigrip Gold Screw for Ext. Hex, M2, Ø2.7mm Head Unigrip Gold Screw for Ext. Hex, M2 Long, Ø2.7mm Head Unigrip Gold Screw for Ext. Hex, M2, Ø2.4mm Head Unigrip Gold Screw for Ext. Hex, Z-Series M2, Ø2.7mm Head Unigrip Gold Screw for Ext. Hex, Z-Series M2, Ø2.4mm Head Temporary Healing Cap for Ø4.8 Compact Conical, Ø4.8 x 4mm Temporary Healing Cap for Ø4.8 Compact Conical, Ø4.8 x 6mm Temporary Healing Cap for Ø4.8 Compact Conical, Ø7.0 x 4mm Temporary Healing Cap for Ø4.8 Compact Conical, Ø7.0 x 6mm Instrument, Connector to Handpiece Instrument, Connector to Handpiece, Short Instrument, Connector to Handpiece, Universal Instrument, Connector to Handpiece, Universal, Short Instrument, 0.9mm Hex Driver Guided Surgery Zyg-Sleeve, OD Ø4.1 / ID Ø2.8 x 4mm Instrument, 1.22mm/1.27mm Universal Hex Driver, Long Instrument, 1.22mm/1.27mm Universal Hex Driver, Medium Instrument, 1.22mm/1.27mm Universal Hex Driver, Short Instrument, 1.22mm Hex Driver, Long Instrument, 1.22mm Hex Driver, Medium Instrument, 1.22mm Hex Driver, Short Instrument, Handpiece 0.9mm Hex Driver Instrument, Handpiece 1.22mm Hex Driver, Long Instrument, Handpiece 1.22mm Hex Driver, Medium Instrument, Handpiece 1.22mm Hex Driver, Short Instrument, 1.22mm/1.27mm Universal Hex Driver, Handpiece Insert, Long Instrument, 1.22mm/1.27mm Universal Hex Driver, Handpiece Insert, Medium Instrument, 1.22mm/1.27mm Universal Hex Driver, Handpiece Insert, Short Instrument, Handpiece 1.22mm Tapered Hex Driver, Long Instrument, Ratchet Wrench Instrument, Fixture Mount Spanner Instrument, Torque Wrench, Surgical Instrument, 100Ncm Bending Attachment, I-TWS Instrument, 45Ncm Bending Attachment, I-TWS Instrument, 0.9mm Hex Driver, Wrench Insert Instrument, 1.22mm Hex Driver, Wrench Insert, Long Instrument, 1.22mm Hex Driver, Wrench Insert, Medium Instrument, 1.22mm Hex Driver, Wrench Insert, Short Instrument, 1.22mm/1.27mm Universal Hex Driver, Wrench Insert, Long Instrument, 1.22mm/1.27mm Universal Hex Driver, Wrench Insert, Medium Instrument, 1.22mm/1.27mm Universal Hex Driver, Wrench Insert, Short Instrument, Wrench Converter for W&H Hex Tools, Ø7.0mm Instrument, Converter for Southern Fixture Mount Hex Instrument, Converter for Southern Latch Instrument, Converter for Southern Square Instrument Tray for Zygomatic, Large Instrument, Zygomatic Depth Gauge Instrument, Direction Indicator, Zygomatic Instrument, Zygomatic Implant Inserter, Square Instrument, Zygomatic Implant Inserter, Hex Instrument, Zygomatic Retractor Digital Lab Analogue for Ø4.0 Ex Hex Digital Lab Analogue for Ø4.8 Compact Conical Analogue, Ø4.0 Ext. Hex Analogue for Ø4.8 Compact Conical Abutment ExHex ONC, Ø4.3 x 27.5mm ExHex ONC, Ø4.3 x 32.5mm ExHex ONC, Ø4.3 x 37.5mm ExHex ONC, Ø4.3 x 42.5mm ExHex ONC, Ø4.3 x 47.5mm Passive Abutment for Ø4.8 Compact Conical Plastic Sleeve for Ø4.8 Compact Conical Passive Abutment Titanium Cylinder for Ø4.8 Compact Conical Passive Abutment Temporary Peek Abutment, Non-Engaging, for Ø4.0 Ex Hex, 2mm Cuff Temporary Peek Abutment for Ø4.8 Compact Conical Passive Abutment, Non-Engaging, for Ø4.0 Ex Hex Titanium Cylinder for Ø4.0 Ex Hex Passive Abutment, Non-Engaging Coverscrew for Ø4.0 Ex Hex Scanning Flag, Titanium, for Ø4.0 Ex Hex Scanning Flag, Titanium, for Ø4.8 Compact Conical Abutment Healing Abutment for Ø4.0 Ex Hex, Ø4.5 x 2mm Healing Abutment for Ø4.0 Ex Hex, Ø4.5 x 3mm Healing Abutment for Ø4.0 Ex Hex, Ø4.5 x 4mm Healing Abutment for Ø4.0 Ex Hex, Ø4.5 x 5mm Healing Abutment for Ø4.0 Ex Hex, Ø4.5 x 6mm Healing Abutment for Ø4.0 Ex Hex, Ø4.5 x 8mm Titanium Abutment, Non-Engaging, for Ø4.0 Ex Hex, 1mm Cuff Titanium Abutment, Non-Engaging, for Ø4.0 Ex Hex, 5mm Cuff Titanium Abutment Base for Ø4.0 Ex Hex, Non-Engaging Titanium Abutment Base for Ø4.0 Ex Hex, 1.5mm Collar, Non-Engaging Titanium Abutment Base for Ø4.0 Ex Hex, 3mm Collar, Non-Engaging Titanium Abutment for Ø4.8 Compact Conical, 1mm Cuff Titanium Abutment for Ø4.8 Compact Conical, 5mm Cuff Titanium Abutment, Smooth, for Ø4.8 Compact Conical Hexed Titanium Screw, M1.4, Ø2.25mm Head Hexed Titanium Screw for Ext. Hex, M2, Ø2.7mm Head Hexed Titanium Screw for Ext. Hex, M2, Ø2.4mm Head Hexed Titanium Screw for Ext. Hex, Z-Series M2, Ø2.4mm Head Slotted Titanium Screw, M1.4, Ø2.25mm Head Slotted Titanium Screw, M1.4 Long, Ø2.25mm Head Slotted Titanium Screw for Ext. Hex, M2, Ø2.7mm Head Slotted Titanium Screw for Ext. Hex, M2 Long, Ø2.7mm Head Slotted Titanium Screw for Ext. Hex, M2, Ø2.4mm Head Slotted Titanium Screw for Ext. Hex, M2 Long, Ø2.4mm Head Slotted Titanium Screw for Ext. Hex, Z-Series M2, Ø2.7mm Head Slotted Titanium Screw for Ext. Hex, Z-Series M2, Ø2.4mm Head Unigrip Titanium Screw, M1.4, Ø2.25mm Head Unigrip Titanium Screw for Ext. Hex, M2, Ø2.7mm Head Unigrip Titanium Screw for Ext. Hex, M2, Ø2.4mm Head Unigrip Titanium Screw for Ext. Hex, Z-Series M2, Ø2.7mm Head Unigrip Titanium Screw for Ext. Hex, Z-Series M2, Ø2.4mm Head Healing Abutment for Ø4.0 Ex Hex, Ø5.5 x 2mm Healing Abutment for Ø4.0 Ex Hex, Ø5.5 x 3mm Healing Abutment for Ø4.0 Ex Hex, Ø5.5 x 4mm Healing Abutment for Ø4.0 Ex Hex, Ø5.5 x 6mm Healing Abutment for Ø4.0 Ex Hex, Ø5.5 x 8mm ExHex ZYG, Ø4.3 x 35mm ExHex ZYG, Ø4.3 x 37.5mm ExHex ZYG, Ø4.3 x 40mm ExHex ZYG, Ø4.3 x 42.5mm ExHex ZYG, Ø4.3 x 45mm ExHex ZYG, Ø4.3 x 47.5mm ExHex ZYG, Ø4.3 x 50mm ExHex ZYG, Ø4.3 x 52.5mm ExHex ZYG, Ø4.3 x 55mm ExHex ZYG, Ø4.3 x 60mm Instrument, Try-In Implant, Zygomatic 55° x 35mm Instrument, Try-In Implant, Zygomatic 55° x 45mm Instrument, Try-In Implant, Zygomatic 55° x 52.5mm Instrument, Try-In Implant, Zygomatic 55° x 52.5mm ExHex ZYGAN®, Ø4.3 x 30mm ExHex ZYGAN®, Ø4.3 x 32.5mm ExHex ZYGAN®, Ø4.3 x 35mm ExHex Zygan®, Ø4.3 x 37.5mm ExHex ZYGAN®, Ø4.3 x 40mm ExHex Zygan®, Ø4.3 x 42.5mm ExHex ZYGAN®, Ø4.3 x 45mm ExHex Zygan®, Ø4.3 x 47.5mm ExHex ZYGAN®, Ø4.3 x 50mm ExHex ZYGAN®, Ø4.3 x 52.5mm ExHex ZYGAN®, Ø4.3 x 55mm ExHex ZYGAN®, Ø4.3 x 57.5mm ExHex ZYGAN®, Ø4.3 x 60mm ExHex ZYGEX, Ø3.4 x 30mm ExHex ZYGEX, Ø3.4 x 32.5mm ExHex ZYGEX, Ø3.4 x 35mm ExHex Zygex, Ø3.4 x 37.5mm ExHex ZYGEX, Ø3.4 x 40mm ExHex Zygex, Ø3.4 x 42.5mm ExHex ZYGEX, Ø3.4 x 45mm ExHex Zygex, Ø3.4 x 47.5mm ExHex ZYGEX, Ø3.4 x 50mm ExHex ZYGEX, Ø3.4 x 52.5mm ExHex ZYGEX, Ø3.4 x 55mm ExHex ZYGEX, Ø3.4 x 57.5mm ExHex ZYGEX, Ø3.4 x 60mm
Model Identifier(s)
AMCZ1 AMCZ2 AMCZ3 AMCZ4 AMCZ5 BSH1 BSH2 BSH3 BSS1 BSS1L BSS2 BSS3 CB70 CB75 CBU CBU-W CH-I-DG CIA-NX-40 CMC-1-ICS CMC-ZG-2 CMC1 CMC2 CMC2L D-35T-M15 D-3SPADE-ZYG D-ZYG-27 D-ZYG-27S D-ZYG-27ST-GSL D-ZYG-27ST-GSM D-ZYG-29 D-ZYG-29S D-ZYG-35 D-ZYG-35S D-ZYG-CH-27 D-ZYG-CH-27S D-ZYG-CH-29 D-ZYG-CH-29S D-ZYG-CS D-ZYG-CS-S D-ZYG-RB GC-EX-40 GC-NX-40 GMC1 GSH1 GSQ2 GSQ3 GSQZ2 GSQZ3 GSS1 GSS2 GSS2L GSS3 GSS3L GSSZ2 GSSZ3 GSU1 GSU2 GSU2L GSU3 GSUZ2 GSUZ3 HMC4 HMC6 HMCT7-4 HMCT7-6 I-CON-X I-CON-XS I-CONU-X I-CONU-XS I-CS-HD I-GSZ-4128-L8 I-HD-22U-L I-HD-22U-M I-HD-22U-S I-HD-L I-HD-M I-HD-S I-HHD-09 I-HHD-22L I-HHD-22M I-HHD-22S I-HHD-22U-L I-HHD-22U-M I-HHD-22U-S I-HTHD-22L I-RATCHET-2 I-SP-X I-TWS I-TWS-B100 I-TWS-B45 I-WI-09 I-WI-22L I-WI-22M I-WI-22S I-WI-22U-L I-WI-22U-M I-WI-22U-S I-WI-CST I-WI-SH I-WI-SL I-WI-SS I-ZYG-1 I-ZYG-DG-1 I-ZYG-DI55 I-ZYG-INS-1 I-ZYG-INS-2 I-ZYG-RET-1 LAD-IB LAD-MC LS12 LSMC1 ONC-55-27.5N ONC-55-32.5N ONC-55-37.5N ONC-55-42.5N ONC-55-47.5N PA-MC-48 PA-MC-48P PA-MC-48TC PKB2nh PKC-MC SB-17-TT SB17TTC SCU2 SFT-EX-40 SFT-MC-48 TB2 TB3 TB4 TB5 TB6 TB8 TCB1nh TCB5nh TIB-NX-40 TIB-NX-40-C1.5 TIB-NX-40-C3 TMC1 TMC5 TMCSL TSH1 TSH2 TSH3 TSHZ3 TSS1 TSS1L TSS2 TSS2L TSS3 TSS3L TSSZ2 TSSZ3 TSU1 TSU2 TSU3 TSUZ2 TSUZ3 WB2 WB3 WB4 WB6 WB8 ZYG-55-35N ZYG-55-37.5N ZYG-55-40N ZYG-55-42.5N ZYG-55-45N ZYG-55-47.5N ZYG-55-50N ZYG-55-52.5N ZYG-55-55N ZYG-55-60N ZYG-TR-55-35 ZYG-TR-55-45 ZYG-TR-55-52 ZYG-TR-55-52.5 ZYGAN-30 ZYGAN-32.5 ZYGAN-35 ZYGAN-37.5 ZYGAN-40 ZYGAN-42.5 ZYGAN-45 ZYGAN-47.5 ZYGAN-50 ZYGAN-52.5 ZYGAN-55 ZYGAN-57.5 ZYGAN-60 ZYGEX-30 ZYGEX-32.5 ZYGEX-35 ZYGEX-37.5 ZYGEX-40 ZYGEX-42.5 ZYGEX-45 ZYGEX-47.5 ZYGEX-50 ZYGEX-52.5 ZYGEX-55 ZYGEX-57.5 ZYGEX-60