Nanova Biomaterials Inc
Columbia, MO, US
NANOVA BIOMATERIALS INC appears in FDA device records in Columbia, MO. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Nanova Biomaterials Inc between 2014 and 2018. The busiest year on record is 2015, with 2. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 2 |
| 2017 | 2 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K172977 | Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel | KLE | Substantially Equivalent | |
| K171330 | Nanova Sealant | EBC | Substantially Equivalent | |
| K163672 | Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor | MAI | Substantially Equivalent | |
| K161174 | Nanova Interference Screw | MAI | Substantially Equivalent | |
| K151943 | Vas-Q-Clip | FZP | Substantially Equivalent | |
| K152004 | Nanova Universal Composite | EBF | Substantially Equivalent | |
| K150623 | Nanova Flowable Composite | EBF | Substantially Equivalent | |
| K140349 | STARBRIGHT 5% SODIUM FLUORIDE VARNISH | LBH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011430871 | 3011430871 | NANOVA BIOMATERIALS INC | 3806 Mojave Ct, Columbia, MO 65202 US | 2026 | and 8 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KLEAgent, Tooth Bonding, Resin
- HBTApplier, Hemostatic Clip
- HTWBit, Drill
- FZPClip, Implantable
- MAUEraser, Dental Stain
- MAIFastener, Fixation, Biodegradable, Soft Tissue
- EEGHeat Source For Bleaching Teeth
- HBQInstrument, Clip Removal
- EBHMaterial, Impression Tray, Resin
- EBFMaterial, Tooth Shade, Resin
- LXHOrthopedic Manual Surgical Instrument
- OJHOrthopedic Tray
- HWPPunch, Femoral Neck
- HXXScrewdriver
- EBCSealant, Pit And Fissure, And Conditioner
- EIDSyringe, Restorative And Impression Material
- HWXTap, Bone
- FSMTray, Surgical, Instrument
- LBHVarnish, Cavity
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain