Data / Medical devices / United States / 3D Diagnostix Inc
3D Diagnostix Inc: FDA-registered device maker in Allston, MA, United States, 2 510(k) clearances
3D Diagnostix Inc is registered with the FDA (registration 3011429437) in Allston, MA, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 22, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011429437
- Address
- 24 Denby rd Suite 148, Allston, MA, United States, 02134
- Owner or operator
- 3D Diagnostix inc (10049937)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 20, 2015
- Registered through
- 2026
- Brand names listed
- 3DDX AOX Kit, 3DDX Drills, 3DDX Fixation Pins, 3DDX Keys, 3DDX Surgical Guide, 3DDX Tissue Punch, Night Guard
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Aligner, Sequential | NXC | 2 | Manufacturer | accessdata.fda.gov |
| Fixture Mount Kit | NYE | 1 | Manufacturer | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| December 22, 2020 | K200908 | iSMILE | NXC | Substantially Equivalent | 3D Diagnostix, Inc. | accessdata.fda.gov |
| November 25, 2020 | K202465 | Night Guard | MQC | Substantially Equivalent | 3D Diagnostix, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Mouthguard, Prescription
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Aligner, Sequential
- All makers of Fixture Mount Kit
Updated December 22, 2020. 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.