Southern Implants PROVATA Implant System - HSA Registration DE0509821

Access comprehensive regulatory information for Southern Implants PROVATA 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 DE0509821 and owned by Southern Implants (PTY) LTD. The device was registered on September 20, 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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HSA Official Data

CLASS C

DE0509821

Southern Implants PROVATA Implant System

HSA Registration Number: DE0509821

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Product Description

The devices are intended to treat partially or fully edentulous patients eligible for placement of one or more dental implants as a means of fixing a permanent or removable single crown, partial or full-arch dental prosthesis in the upper or lower jaw. The devices allow for immediate or delayed prosthetic restoration based on the user’s evaluation of the patient’s eligibility. The PROVATA® Implant System is intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. The PROVATA® Implant System is intended for immediate function when good primary stability with appropriate occlusal loading is achieved. The intended use for the Ø3.30 mm PROVATA® implants is limited to replacement of maxillary and mandibular lateral and central incisors

Device Classification

Device Class

CLASS C

Medical Speciality Area

Dental

Registration Information

Registration Number

DE0509821

Registration Date

September 20, 2024

Retention Due Date

September 19, 2025

Product Owner

Name

Southern Implants (PTY) LTD

Short Name

Southern Implants (PTY) LTD

Address

1 Albert Rd, Irene, 0062, SOUTH AFRICA

Registrant

Name

ASIA ACTUAL PTE. LTD.

Address

116 CHANGI ROAD, WIS@CHANGI, #04-05, SINGAPORE 419718

Model Information

Model Name(s)

Custom Abutment Base for Int. Hex, Engaging Custom Abutment Base for Int. Hex, Ø4.5 Platform Match, Engaging Custom Abutment Base for Int. Hex, Non-Engaging Scanning Abutment for Int. Hex, Engaging Scanning Abutment for Int. Hex, Non-Engaging Cover Screw for Ø3.3 Provata® Cover Screw for Int. Hex Pilot Drill, Ø1.2 x 15mm Side Cutting Twist Drill, Ø1.6mm Twist Drill, Ø2.0 x 10mm Twist Drill, Ø2.0 x 15mm Tapered Drill for Piccolo, Ø3.0 x 10mm Tapered Drill for Piccolo, Ø3.0 x 11.5mm Tapered Drill for Piccolo, Ø3.0 x 13mm Tapered Drill for Piccolo, Ø3.0 x 15mm Tapered Drill for Piccolo, Ø3.0 x 8.5mm Tapered Drill, Ø3.3 x 10mm Tapered Drill, Ø3.3 x 11.5mm Tapered Drill, Ø3.3 x 13mm Tapered Drill, Ø3.3 x 15mm Tapered Drill, Ø3.3 x 18mm Tapered Drill, Ø3.3 x 8.5mm Spade Drill, Ø1.8 x 16mm Tapered Drill, Ø4.0 x 10mm Tapered Drill, Ø4.0 x 11.5mm Tapered Drill, Ø4.0 x 13mm Tapered Drill, Ø4.0 x 15mm Tapered Drill, Ø4.0 x 18mm Tapered Drill, Ø4.0 x 6mm Tapered Drill, Ø4.0 x 8.5mm Tapered Drill, Ø5.0 x 10mm Tapered Drill, Ø5.0 x 11.5mm Tapered Drill, Ø5.0 x 13mm Tapered Drill, Ø5.0 x 15mm Tapered Drill, Ø5.0 x 18mm Tapered Drill, Ø5.0 x 6mm Tapered Drill, Ø5.0 x 8.5mm Counterbore, Ø3.0 - Ø4.0mm Counterbore, Ø4.0 - Ø5.0mm Counterbore, Ø2.0 - Ø3.0mm Countersink, Ø5.0 - Ø6.7mm Countersink, Ø4.0 - Ø5.5mm Round Burr, Ø1.8mm Equator Overdenture Abutment for Int. Hex, Ø3.6 x 2mm Cuff Equator Overdenture Abutment for Int. Hex, Ø3.6 x 4mm Cuff Equator Overdenture Abutment for Int. Hex, Ø3.6 x 6mm Cuff Gold Abutment, Engaging, for Int. Hex Gold Abutment, Non-Engaging, for Int. Hex Gold Abutment for Ø4.8 Compact Conical, 1mm Cuff Quad Gold Screw for Int. Hex Hexed Gold Screw, M1.4, Ø2.25mm Head Slotted Gold Screw, M1.4, Ø2.25mm Head Unigrip Gold Screw, M1.4, Ø2.25mm Head Healing Abutment for Ø3.3 Provata®, Ø3.5x3mm Healing Abutment for Ø3.3 Provata®, Ø3.5x4mm Healing Abutment for Ø3.3 Provata®, Ø3.5x6mm Healing Abutment for Ø3.3 Provata®, Ø4.5x3mm Healing Abutment for Ø3.3 Provata®, Ø4.5x4mm Healing Abutment for Ø3.3 Provata®, Ø4.5x6mm Healing Abutment for Int. Hex, Ø3.7 x 3mm Healing Abutment for Int. Hex, Ø3.7 x 4mm Healing Abutment for Int. Hex, Ø3.7 x 6mm Healing Abutment for Int. Hex, Ø4.5 x 3mm Healing Abutment for Int. Hex, Ø4.5 x 4mm Healing Abutment for Int. Hex, Ø4.5 x 6mm Healing Abutment for Int. Hex, Ø5.5 x 3mm Healing Abutment for Int. Hex, Ø5.5 x 4mm Healing Abutment for Int. Hex, Ø5.5 x 6mm Healing Abutment for Int. Hex, Ø4.5 Platform Match, Ø5.5 x 3mm Healing Abutment for Int. Hex, Ø4.5 Platform Match, Ø5.5 x 4mm Healing Abutment for Int. Hex, Ø4.5 Platform Match, Ø5.5 x 6mm Instrument, Drill Extension for Handpiece Insert, Ganter Instrument, HP Drill Extension Guided Surgery, Ø4.1 Instrument, Drill Extension for Handpiece Insert, Komet Instrument, Narrow Drill Extension, Handpiece Insert Handpiece Insertion Tool for Int. Hex Co-Axis, Long Handpiece Insertion Tool for Int. Hex Co-Axis, Med 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 1.27mm Hex Driver, Medium Instrument, Handpiece 1.27mm Hex Driver, Short Handpiece Insertion Tool for Int. Hex, Guided Surgery Handpiece Insertion Tool for Int. Hex, Long Handpiece Insertion Tool for Int. Hex, Medium Handpiece Insertion Tool for Int. Hex, Short Instrument, Handpiece Quad Driver, Long Instrument, Handpiece Quad Driver, Medium Instrument, Handpiece Quad Driver, Short Handpiece Insertion Tool for Int. Hex, Long Handpiece Insertion Tool for Int. Hex, Medium Handpiece Insertion Tool for Int. Hex, Short Compact Conical Abutment for Ø3.3 Provata®, Ø4.8 x 1mm Cuff Compact Conical Abutment for Ø3.3 Provata®, 20° Angled Compact Conical Abutment for Ø3.3 Provata®, Ø4.8 x 3mm Cuff Compact Conical Abutment for Ø3.3 Provata®, Ø4.8 x 5mm Cuff Compact Conical Abutment for Int. Hex, Ø4.8 x 1mm Cuff Compact Conical Abutment for Int. Hex, 20° Angled Compact Conical Abutment for Int. Hex, Ø4.8 x 3mm Cuff Compact Conical Abutment for Int. Hex, 30° Angled Compact Conical Abutment for Int. Hex, Ø4.8 x 5mm Cuff PROVATA® 12° CO-AXIS®, Ø3.3 x 8.5mm PROVATA® 12° CO-AXIS®, Ø3.3 x 10mm PROVATA® 12° CO-AXIS®, Ø3.3 x 11.5mm PROVATA® 12° CO-AXIS®, Ø3.3 x 13mm PROVATA® 12° CO-AXIS®, Ø3.3 x 15mm PROVATA® 12° CO-AXIS®, Ø3.3 x 18mm PROVATA® 12° CO-AXIS®, Ø4.0 x 8.5mm PROVATA® 12° CO-AXIS®, Ø4.0 x 10mm PROVATA® 12° CO-AXIS®, Ø4.0 x 11.5mm PROVATA® 12° CO-AXIS®, Ø4.0 x 13mm PROVATA® 12° CO-AXIS®, Ø4.0 x 15mm PROVATA® 12° CO-AXIS®, Ø4.0 x 18mm PROVATA® 12° CO-AXIS®, Ø5.0 x 8.5mm PROVATA® 12° CO-AXIS®, Ø5.0 x 10mm PROVATA® 12° CO-AXIS®, Ø5.0 x 11.5mm PROVATA® 12° CO-AXIS®, Ø5.0 x 13mm PROVATA® 12° CO-AXIS®, Ø5.0 x 15mm PROVATA® 12° CO-AXIS®, Ø5.0 x 18mm PROVATA®, Ø3.3 x 8.5mm PROVATA®, Ø3.3 x 10mm PROVATA®, Ø3.3 x 11.5mm PROVATA®, Ø3.3 x 13mm PROVATA®, Ø3.3 x 15mm PROVATA®, Ø3.3 x 18mm PROVATA®, Ø4.0 x 6mm PROVATA®, Ø4.0 x 8.5mm PROVATA®, Ø4.0 x 10mm PROVATA®, Ø4.0 x 11.5mm PROVATA®, Ø4.0 x 13mm PROVATA®, Ø4.0 x 15mm PROVATA®, Ø4.0 x 18mm PROVATA®, Ø5.0 x 8.5mm PROVATA®, Ø5.0 x 10mm PROVATA®, Ø5.0 x 11.5mm PROVATA®, Ø5.0 x 13mm PROVATA®, Ø5.0 x 15mm PROVATA®, Ø5.0 x 18mm Passive Abutment for Ø3.3 Provata®, Engaging Titanium Ring for Ø3.3 Provata® Passive Abutment, Engaging Passive Abutment for Ø3.3 Provata®, Non-Engaging Titanium Ring for Ø3.3 Provata® Passive Abutment, Non-Engaging Passive Abutment for Int. Hex, Engaging Plastic Sleeve for Int. Hex Passive Abutment, Engaging Passive Abutment for Int. Hex, Engaging, Ø4.5 Platform Match Titanium Cylinder for Int. Hex Passive Abutment, Engaging Plastic Sleeve for Int. Hex Passive Abutment, Engaging Titanium Cylinder for Int. Hex Passive Abutment, Engaging Hexed Titanium Screw for Ø3.3 Provata® Passive Hexed Titanium Screw for Int. Hex Passive Passive Abutment for Ø4.8 Compact Conical Titanium Cylinder for Ø4.8 Compact Conical Passive Abutment Passive Abutment for Int. Hex, Non-Engaging Titanium Cylinder for Int. Hex Passive Abutment, Non-Engaging Titanium Cylinder for Int. Hex Passive Abutment, Non-Engaging Quad Gold Screw for Int. Hex Passive Temporary Peek Abutment for Ø4.8 Compact Conical PROVATA® 12° CO-AXIS®, Ø4.0 x 8.5mm PROVATA® 12° CO-AXIS®, Ø4.0 x 10mm PROVATA® 12° CO-AXIS®, Ø4.0 x 11.5mm PROVATA® 12° CO-AXIS®, Ø4.0 x 13mm PROVATA® 12° CO-AXIS®, Ø4.0 x 15mm PROVATA® 12° CO-AXIS®, Ø4.0 x 18mm PROVATA® 12° CO-AXIS®, Ø5.0 x 8.5mm PROVATA® 12° CO-AXIS®, Ø5.0 x 10mm PROVATA® 12° CO-AXIS®, Ø5.0 x 11.5mm PROVATA® 12° CO-AXIS®, Ø5.0 x 13mm PROVATA® 12° CO-AXIS®, Ø5.0 x 15mm PROVATA® 12° CO-AXIS®, Ø5.0 x 18mm PROVATA®, Ø3.3 x 8.5mm PROVATA®, Ø3.3 x 10mm PROVATA®, Ø3.3 x 11.5mm PROVATA®, Ø3.3 x 13mm PROVATA®, Ø3.3 x 15mm PROVATA®, Ø3.3 x 18mm PROVATA®, Ø4.0 x 6.4mm PROVATA®, Ø4.0 x 8.5mm PROVATA®, Ø4.0 x 10mm PROVATA®, Ø4.0 x 11.5mm PROVATA®, Ø4.0 x 13mm PROVATA®, Ø4.0 x 15mm PROVATA®, Ø4.0 x 18mm PROVATA®, Ø5.0 x 8.5mm PROVATA®, Ø5.0 x 10mm PROVATA®, Ø5.0 x 11.5mm PROVATA®, Ø5.0 x 13mm PROVATA®, Ø5.0 x 15mm PROVATA®, Ø5.0 x 18mm Titanium Abutment for Ø3.3 PROVATA, Engaging Titanium Abutment for Ø3.3 PROVATA, Non-Engaging Titanium Abutment for Int. Hex, Engaging Titanium Abutment for Int. Hex, Non-Engaging Cosmetic Abutment for Int. Hex Cosmetic Abutment for Int. Hex, 12° Angled Cosmetic Abutment for Int. Hex, 24° Angled Titanium Abutment Base for Int. Hex Titanium Abutment Base for Int. Hex, 1.5mm Collar Titanium Abutment Base for Int. Hex, 3mm Collar Titanium Abutment Base for Int. Hex, Ø4.5 Platform Match Titanium Abutment Base for Int. Hex, Non-Engaging Titanium Abutment Base for Int. Hex, 1.5mm Collar, Non-Engaging Titanium Abutment Base for Int. 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 for Ø3.3 PROVATA® Hexed Titanium Screw for Int. Hex Hexed Titanium Screw for Int. Hex, Angled Abutment Hexed Titanium Screw, M1.4, Ø2.25mm Head Slotted Titanium Screw, M1.4, Ø2.25mm Head Unigrip Titanium Screw, M1.4, Ø2.25mm Head

Model Identifier(s)

CAB-M CAB-M-P45 CAB-NM CIA-EM CIA-NM CS-3M CS-M D-12T-M15 D-16-T D-20T-M10 D-20T-M15 D-30TP-10 D-30TP-11.5 D-30TP-13 D-30TP-15 D-30TP-8.5 D-33TP-10 D-33TP-11.5 D-33TP-13 D-33TP-15 D-33TP-18 D-33TP-8.5 D-3SPADE-1.8M D-40TP-10 D-40TP-11.5 D-40TP-13 D-40TP-15 D-40TP-18 D-40TP-6 D-40TP-8.5 D-50TP-10 D-50TP-11.5 D-50TP-13 D-50TP-15 D-50TP-18 D-50TP-6 D-50TP-8.5 D-CB-40M D-CB-50M D-CB-F D-CSS-5 D-CSS-M D-RB-MS EQ-M-2 EQ-M-4 EQ-M-6 GC-EM GC-NM GMC1 GS-Q-18 GSH1 GSS1 GSU1 HA-3M-35-3 HA-3M-35-4 HA-3M-35-6 HA-3M-45-3 HA-3M-45-4 HA-3M-45-6 HA-M-37-3 HA-M-37-4 HA-M-37-6 HA-M-45-3 HA-M-45-4 HA-M-45-6 HA-M-55-3 HA-M-55-4 HA-M-55-6 HA-M-P45-3 HA-M-P45-4 HA-M-P45-6 I-DE-G I-DE-GS4 I-DE-K I-DE-MN I-H-PRO12D-L I-H-PRO12D-M I-HHD-22U-L I-HHD-22U-M I-HHD-22U-S I-HHD-27M I-HHD-27S I-HM-GS I-HM-L I-HM-M I-HM-S I-HQD-L I-HQD-M I-HQD-S I-HZ-L I-HZ-M I-HZ-S MC-3M-1 MC-3M-20D MC-3M-3 MC-3M-5 MC-M-1 MC-M-20d MC-M-3 MC-M-30d MC-M-5 MSC-PRO12D308 MSC-PRO12D310 MSC-PRO12D311 MSC-PRO12D313 MSC-PRO12D315 MSC-PRO12D318 MSC-PRO12D408 MSC-PRO12D410 MSC-PRO12D411 MSC-PRO12D413 MSC-PRO12D415 MSC-PRO12D418 MSC-PRO12D508 MSC-PRO12D510 MSC-PRO12D511 MSC-PRO12D513 MSC-PRO12D515 MSC-PRO12D518 MSC-PRO308 MSC-PRO310 MSC-PRO311 MSC-PRO313 MSC-PRO315 MSC-PRO318 MSC-PRO406 MSC-PRO408 MSC-PRO410 MSC-PRO411 MSC-PRO413 MSC-PRO415 MSC-PRO418 MSC-PRO508 MSC-PRO510 MSC-PRO511 MSC-PRO513 MSC-PRO515 MSC-PRO518 PA-3EM-S PA-3EM-STC PA-3NM-S PA-3NM-STC PA-EM-S PA-EM-SP PA-EM-SP45 PA-EM-STC PA-EZ-P PA-EZ-TC PA-M-16T PA-M-18T PA-MC-48 PA-MC-48TC PA-NM-S PA-NM-STC PA-NZ-TC PA-Q-18G PKC-MC PRO12D408 PRO12D410 PRO12D411 PRO12D413 PRO12D415 PRO12D418 PRO12D508 PRO12D510 PRO12D511 PRO12D513 PRO12D515 PRO12D518 PRO308 PRO310 PRO311 PRO313 PRO315 PRO318 PRO406 PRO408 PRO410 PRO411 PRO413 PRO415 PRO418 PRO508 PRO510 PRO511 PRO513 PRO515 PRO518 TC-3M TC-3NM TC-M TC-NM TCA-M TCA12-M TCA24-M TIB-M TIB-M-C1.5 TIB-M-C3 TIB-M-P45 TIB-NM TIB-NM-C1.5 TIB-NM-C3 TMC1 TMC5 TMCSL TS-Z-16 TS-Z-18 TS-Z-MC-18 TSH1 TSS1 TSU1