ASIGA

FDA Device Registration & Listing · Alexandria New South Wales, AU · Registration 3024227208

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3024227208
FEI Number
3024227208
Entity Name
ASIGA
City/State/Country
Alexandria New South Wales, AU
Establishment Address
Unit 2 19-21 Bourke Road,, Alexandria New South Wales 2015, AU
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Asiga (Owner Number: 10085950)
Owner / Operator Contact Address
Unit 2 19-21 Bourke Road,, Alexandria, AU-NSW 2015, AU
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

DentaTRY DentaGUIDE DentaTOOTH DentaIBT DentaTRAY DentaTRAY Orange

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2023-01-17
PZY Additively Manufactured, Preformed, Resin Denture Tooth Dental Class 2 872.3590 2023-01-17
QJJ Indirect Bonding Tray Dental Class 1 872.5410 2023-01-17
EBH Material, Impression Tray, Resin Dental Class 1 872.3670 2023-01-17

Official Correspondent

Joseph Azar

US Agent Details

Cory Lambertson Business: Asiga America Inc. Email: cory@asiga.com Phone: (877) 6899998

Related Public Records

Same Entity

Asiga
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0013-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024227208. Last updated year: 2026. Please use registration number 3024227208 when referencing this establishment in official correspondence.
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