Data / Medical devices / Japan / Neo Dental Chemical Products Co., Ltd.
Neo Dental Chemical Products Co., Ltd.: FDA-registered device maker in Nagano, Japan, 4 510(k) clearances
Neo Dental Chemical Products Co., Ltd. is registered with the FDA (registration 1000492377) in Nagano, Japan. It lists 7 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 7, 2011. 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
- 1000492377
- Address
- 4010-17 Wada, Matsumoto-shi, Nagano, Japan, 390-1242
- Owner or operator
- NEO DENTAL CHEMICAL PRODUCTS CO., LTD. (9023877)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- September 28, 2006
- Registered through
- 2026
- Brand names listed
- Cavios, ENDODONTIC SEALER, Evadyne, Micro Aspirator, Multi Suction E-Type, Neo Blue Tips, Neo Clear Tips, Neo Flexpoint and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheters, Suction, Tracheobronchial | BSY | 1 | Manufacturer | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Filling, Plastic, Dental | EIY | 1 | Manufacturer | accessdata.fda.gov |
| Liner, Cavity, Calcium Hydroxide | EJK | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Dental | DZM | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Resin, Root Canal Filling | KIF | 2 | 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 |
|---|---|---|---|---|---|---|
| September 7, 2011 | K111666 | EVADYNE TEMPORARY CROWN AND BRIDGE RESIN | EBG | Substantially Equivalent | Neodental Chemical Products Co., Ltd. | accessdata.fda.gov |
| August 19, 2011 | K111668 | CAVIOS CAVITY LINER | EJK | Substantially Equivalent | Neodental Chemical Products Co., Ltd. | accessdata.fda.gov |
| November 6, 1997 | K973667 | VITAPEX PRE-LOADED DENTAL SYRINGE | KIF | Substantially Equivalent | Neodental Chemical Products Co., Ltd. | accessdata.fda.gov |
| July 24, 1997 | K971642 | DENTALIS KEZ ENDODONITC SEALER | EMA | Substantially Equivalent | Neodental Chemical Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Needle, Dental
- All makers of Catheters, Suction, Tracheobronchial
- All makers of Resin, Root Canal Filling
- All makers of Instrument, Filling, Plastic, Dental
- All makers of Cement, Dental
Updated September 7, 2011. 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.