Registered with FDA
Axiodent Inc.
Wilmington, DE, United States. Lists 12 dental device types with FDA across 1 registered establishment.
- Device types listed
- 12
- Brands and models
- 14
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Axiodent Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | — | 2024 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | — | 2025 |
| Shellac Base PlateEEA · Class 1 | — | Lister | AxioBase | 2024 |
| Intraoral Dental WaxEGD · Class 1 | — | Lister | AxioModelling Wax | 2024 |
| Calcium Hydroxide Cavity LinerEJK · Class 2 | — | Lister | — | 2024 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Lister | AxioGlossAxioShine Fresh FruitAxioShine Fresh MintAxioShine Fresh OrangeAxioShine Fresh PineappleAxioShine Fresh Strawberry | 2024 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | — | 2024 |
| Dental CementEMA · Class 2 | Dental cements | Lister | — | 2024 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Lister | AxioIRMAxioIRM XSAxioZi-Temp | 2024 |
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Lister | — | 2024 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Lister | — | 2024 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Lister | Axio-3D Burn OutAxio-3D Model ProAxio-3D Surgical Guide | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Axiodent Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Prevest Denpro Limited (7).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 27 Nov 2024 | K233273 | C&B Ceramic; C&B Permanent; C&B Interim | Prevest Denpro Limited | EBF Resin Tooth Shade Material |
| 5 Jan 2024 | K231263 | Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT | Prevest Denpro Limited | EBF Resin Tooth Shade Material |
| 11 Aug 2023 | K231696 | Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal | Prevest Denpro Limited | KLE Resin Tooth Bonding Agent |
| 9 Sep 2022 | K213244 | Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) | Prevest Denpro Limited | ELW Impression Material |
| 23 May 2022 | K212563 | CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid | Prevest Denpro Limited | KIF Root Canal Filling Resin |
| 13 May 2022 | K212475 | Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) | Prevest Denpro Limited | EJK Calcium Hydroxide Cavity Liner |
| 13 May 2021 | K200555 | Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) | Prevest Denpro Limited | EMA Dental Cement |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| AXIODENT INC.FDA reg. 3032312561 | Wilmington, DE, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10091372). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.