Data / Medical devices / United States / Nanova Biomaterials Inc
Nanova Biomaterials Inc: FDA-registered device maker in Columbia, MO, United States, 7 510(k) clearances
Nanova Biomaterials Inc is registered with the FDA (registration 3011430871) in Columbia, MO, United States. It lists 18 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 8, 2017. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3011430871
- Address
- 3806 Mojave Ct, Columbia, MO, United States, 65202
- Owner or operator
- Nanova Biomaterials Inc (10048463)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- January 15, 2015
- Registered through
- 2026
- Brand names listed
- NovaBright 5% NaF Varnish, NovaShine Teeth Whitening Pen, NovaShine Whitening Kit, Novashine Teeth Whitening Gel Refill Pack, StarBright 5% NaF Varnish, Vas-Q-Clip, Vas-Q-Clip Appliers
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applier, Hemostatic Clip | HBT | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Clip, Implantable | FZP | 2 | Manufacturer | accessdata.fda.gov |
| Eraser, Dental Stain | MAU | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | 2 | Manufacturer | accessdata.fda.gov |
| Heat Source For Bleaching Teeth | EEG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Clip Removal | HBQ | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Orthopedic Tray | OJH | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Punch, Femoral Neck | HWP | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Sealant, Pit And Fissure, And Conditioner | EBC | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Varnish, Cavity | LBH | 2 | Manufacturer, Manufacturer for export | 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 |
|---|---|---|---|---|---|---|
| September 8, 2017 | K171330 | Nanova Sealant | EBC | Substantially Equivalent | Nanova Biomaterials, Inc. | accessdata.fda.gov |
| May 5, 2017 | K163672 | Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor | MAI | Substantially Equivalent | Nanova Biomaterials, Inc. | accessdata.fda.gov |
| November 3, 2016 | K161174 | Nanova Interference Screw | MAI | Substantially Equivalent | Nanova Biomaterials, Inc. | accessdata.fda.gov |
| March 25, 2016 | K151943 | Vas-Q-Clip | FZP | Substantially Equivalent | Nanova Biomaterials, Inc. | accessdata.fda.gov |
| November 17, 2015 | K152004 | Nanova Universal Composite | EBF | Substantially Equivalent | Nanova Biomaterials, Inc. | accessdata.fda.gov |
| June 18, 2015 | K150623 | Nanova Flowable Composite | EBF | Substantially Equivalent | Nanova Biomaterials, Inc. | accessdata.fda.gov |
| September 22, 2014 | K140349 | STARBRIGHT 5% SODIUM FLUORIDE VARNISH | LBH | Substantially Equivalent | Nanova Biomaterials, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Tap, Bone
- All makers of Tray, Surgical, Instrument
- All makers of Clip, Implantable
- All makers of Heat Source For Bleaching Teeth
- All makers of Orthopedic Tray
- All makers of Varnish, Cavity
Updated September 8, 2017. 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.