Manufacturer registered with FDA
Neodental Chemical Products Co., Ltd.
SHIBUYA-KU, TOKYO, Japan. Lists 6 dental device types with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 6
- Brands and models
- 8
- 510(k) clearances
- 51996–2011
- Markets registered in
- 23 registrations outside the US
- Establishments
- 1Japan
510(k) clearances per year, 1990–2026
Registered in 2 markets
Where regulators' registries name Neodental Chemical Products Co., Ltd. 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 | Neodental Chemical Products Co., Ltd. | 5 clearances | 1996–2011 | Below |
| Taiwan | TFDA | Manufacturer | NEO DENTAL CHEMICAL PRODUCTS CO. LTD.NEO DENTAL CHEMICAL PRODUCTS CO., LTD. | 3 | 2006–2012 | 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 Neodental Chemical Products Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | Neo Blue TipsNeo Clear Tips | 2015 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | Evadyne | 2011 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | Neo Flexpoint | 2008 |
| Calcium Hydroxide Cavity LinerEJK · Class 2 | — | Maker | Cavios | 2011 |
| Dental CementEMA · Class 2 | Dental cements | Maker | ENDODONTIC SEALER | 2006 |
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Maker | Root Canal MedicamentVitapex | 2007 |
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 Neodental Chemical Products Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 7 Sep 2011 | K111666 | EVADYNE TEMPORARY CROWN AND BRIDGE RESIN | EBG Resin Temporary Crown and Bridge |
| 19 Aug 2011 | K111668 | CAVIOS CAVITY LINER | EJK Calcium Hydroxide Cavity Liner |
| 6 Nov 1997 | K973667 | VITAPEX PRE-LOADED DENTAL SYRINGE | KIF Root Canal Filling Resin |
| 24 Jul 1997 | K971642 | DENTALIS KEZ ENDODONITC SEALER | EMA Dental Cement |
| 20 May 1996 | K955703 | NEO DENTAL ENDODONTIC IRRIGATION SYRINGE | KIF Root Canal Filling Resin |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| NEO DENTAL CHEMICAL PRODUCTS CO., LTD.FDA reg. 1000492377 | NAGANO, Japan | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9023877). 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.