Registered with FDA
美国英泰国际公司Invotec International Inc.
Jacksonville, FL, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 10159 registrations outside the US
- Establishments
- 1United States
Registered in 10 markets
Where regulators' registries name 美国英泰国际公司Invotec International 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 | Lister | 美国英泰国际公司Invotec International Inc. | 1 device types | — | Below |
| Costa Rica | Ministerio de Salud | Manufacturer | Invotec International, Inc | 106 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Invotec International, Inc. | 16 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | INVOTEC INTERNATIONAL INC | 9 | 1999–2017 | Pure Global AI |
| Israel | AMAR | Manufacturer | Invotec International IncInvotec International, Inc · Invotec International, Inc. · +1 | 9 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | INVOTEC INTERNATIONAL INCInvotec International Inc | 8 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | INVOTEC INTERNATIONAL INC. | 6 | 2013–2017 | Pure Global AI |
| China | NMPA | Registration holder | 美国英泰国际公司INVOTEC INTERNATIONAL,INC.美国英泰国际公司Invotec International Inc. | 2 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | INVOTEC INTERNATIONAL, INCINVOTEC INTERNATIONAL, INC. | 2 | 2010–2013 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Invotec International, Inc. | 1 | 2018–2018 | 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 美国英泰国际公司Invotec International 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 |
|---|---|---|---|---|
| Nose and Throat Ear CementNEA · Class 2 | — | Lister | SerenoCem Otologic Bone Cement | 2011 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
美国英泰国际公司Invotec International Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Corinthian Medical , Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 12 Feb 2001 | K003567 | SERENOCEM, MODEL BC 010 | Corinthian Medical , Ltd. | NEA Nose and Throat Ear Cement |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| INVOTEC INTERNATIONAL, INC.FDA reg. 1052728 | Jacksonville, FL, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9000512). 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.