Data / Medical devices / United States / Axiodent Inc.
Axiodent Inc.: FDA-registered device maker in Wilmington, DE, United States, 7 510(k) clearances
Axiodent Inc. is registered with the FDA (registration 3032312561) in Wilmington, DE, United States. It lists 12 device types. The FDA files 7 510(k) clearances under its listings, the newest dated November 27, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3032312561
- Address
- 501 Silverside Rd Ste 105 # 5086, Wilmington, DE, United States, 19809
- Owner or operator
- Axiodent Inc. (10091372)
- Roles
- Repackager or relabeler
- First device listed
- September 9, 2024
- Registered through
- 2026
- Brand names listed
- Axio-3D Burn Out, Axio-3D Model Pro, Axio-3D Surgical Guide, AxioBase, AxioGloss, AxioIRM, AxioIRM XS, AxioModelling Wax and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Agent, Tooth Bonding, Resin | KLE | 2 | Repackager or relabeler | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Liner, Cavity, Calcium Hydroxide | EJK | 2 | Repackager or relabeler | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Plate, Base, Shellac | EEA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Resin, Root Canal Filling | KIF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Zinc Oxide Eugenol | EMB | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 27, 2024 | K233273 | C&B Ceramic; C&B Permanent; C&B Interim | EBF | Substantially Equivalent | Prevest Denpro Limited | accessdata.fda.gov |
| January 5, 2024 | K231263 | Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT | EBF | Substantially Equivalent | Prevest Denpro Limited | accessdata.fda.gov |
| August 11, 2023 | K231696 | Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal | KLE | Substantially Equivalent | Prevest Denpro Limited | accessdata.fda.gov |
| September 9, 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) | ELW | Substantially Equivalent | Prevest Denpro Limited | accessdata.fda.gov |
| May 23, 2022 | K212563 | CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid | KIF | Substantially Equivalent | Prevest Denpro Limited | accessdata.fda.gov |
| May 13, 2022 | K212475 | Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) | EJK | Substantially Equivalent | Prevest Denpro Limited | accessdata.fda.gov |
| May 13, 2021 | K200555 | Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) | EMA | Substantially Equivalent | Prevest Denpro Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Material, Tooth Shade, Resin
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Cement, Dental
- All makers of Liner, Cavity, Calcium Hydroxide
- All makers of Agent, Tooth Bonding, Resin
- All makers of Wax, Dental, Intraoral
Updated November 27, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.