Manufacturer registered with FDA
Nanova Biomaterials Inc
Columbia, MO, United States. Lists 7 dental device types with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 7
- Brands and models
- 5
- 510(k) clearances
- 52014–2018
- Markets registered in
- 715 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 7 markets
Where regulators' registries name Nanova Biomaterials Inc as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Nanova Biomaterials Inc | 5 clearances | 2014–2018 | Below |
| China | NMPA | Registration holder | 纳华生物科技有限公司NANOVA BIOMATERIALS INC纳华生物科技有限公司Nanova Biomaterials, Inc. | 3 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Nanova Biomaterials Inc.NANOVA BIOMATERIALS, INC | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Nanova Biomaterials Inc. | 3 | 2020–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | NANOVA BIOMATERIALS INC | 2 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | NANOVA BIOMATERIALS INC | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | NANOVA BIOMATERIALS INC | 2 | 2019–2019 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Nanova Biomaterials 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 | Maker | — | 2015 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Maker | NovaBright 5% NaF VarnishStarBright 5% NaF Varnish | 2015 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Maker | — | 2017 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | — | 2018 |
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | — | 2018 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | — | 2016 |
| Dental Stain EraserMAU · Class 1 | — | Maker | Novashine Teeth Whitening Gel Refill PackNovaShine Teeth Whitening PenNovaShine Whitening Kit | 2018 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Nanova Biomaterials Inc as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 16 Jan 2018 | K172977 | Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel | KLE Resin Tooth Bonding Agent |
| 8 Sep 2017 | K171330 | Nanova Sealant | EBC Pit and Fissure Sealant and Conditioner |
| 17 Nov 2015 | K152004 | Nanova Universal Composite | EBF Resin Tooth Shade Material |
| 18 Jun 2015 | K150623 | Nanova Flowable Composite | EBF Resin Tooth Shade Material |
| 22 Sep 2014 | K140349 | STARBRIGHT 5% SODIUM FLUORIDE VARNISH | LBH Cavity Varnish |
Some of these clearances are listed with FDA today by another company: AMD Medicom Inc (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| NANOVA BIOMATERIALS INCFDA reg. 3011430871 | Columbia, MO, United States | Complaint file establishment, Contract manufacturer, Manufacturer for export, Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10048463). 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.