AXIODENT INC.

FDA Device Registration & Listing · Wilmington, DE, US · Registration 3032312561

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
3032312561
FEI Number
3032312561
Entity Name
AXIODENT INC.
City/State/Country
Wilmington, DE, US
Establishment Address
501 Silverside Rd Ste 105 # 5086, Wilmington, DE 19809, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Axiodent Inc. (Owner Number: 10091372)
Owner / Operator Contact Address
501 Silverside Rd Suite 105 #5086, Wilmington, DE 19809, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Axio-3D Model Pro Axio-3D Burn Out Axio-3D Surgical Guide AxioShine Fresh Mint AxioShine Fresh Fruit AxioShine Fresh Strawberry AxioShine Fresh Orange AxioGloss AxioShine Fresh Pineapple AxioIRM XS AxioZi-Temp AxioIRM AxioModelling Wax AxioBase

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ELW Material, Impression Dental Class 2 872.3660 2024-09-09
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2025-01-05
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2025-01-05
EJK Liner, Cavity, Calcium Hydroxide Dental Class 2 872.3250 2024-09-09
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2024-09-22
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2024-09-10
EMB Zinc Oxide Eugenol Dental Class 1 872.3275 2024-09-10
KIF Resin, Root Canal Filling Dental Class 2 872.3820 2024-09-09
EGD Wax, Dental, Intraoral Dental Class 1 872.6890 2024-09-29
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2024-09-09
EEA Plate, Base, Shellac Dental Class 1 872.6200 2024-09-29
EMA Cement, Dental Dental Class 2 872.3275 2024-09-09
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2024-09-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K952614 Dentsply Intl. JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL 1996-08-13
K952662 Jeneric/Pentron, Inc. COMP=FLOW 1995-08-28
K171147 Bisco, Inc. REVEAL Bulk 2017-08-04
K770922 Espe GmbH (Us) DENTAL RESTORATIVE IN CAPSULES 1977-06-01
K153476 Kuraray Noritake Dental, Inc. KATANA AVENCIA Block 2016-08-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0028-2020 Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany 2
Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032312561. Last updated year: 2026. Please use registration number 3032312561 when referencing this establishment in official correspondence.
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