Manufacturer registered with FDA
SIC invent AG
BASEL, Switzerland. Lists 5 dental device types with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 13
- 510(k) clearances
- 52005–2026
- Markets registered in
- 888 registrations outside the US
- Establishments
- 1Switzerland
510(k) clearances per year, 2000–2026
Registered in 8 markets
Where regulators' registries name SIC invent AG 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 | SIC invent AG | 5 clearances | 2005–2026 | Below |
| United Kingdom | MHRA | Manufacturer | SIC invent AG | 45 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | SIC invent AGSIC Invent AG. · SIC invent AG. | 13 | 2006–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SIC INVENT AG | 10 | 2010–2023 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | SIC invent AG | 7 | — | Pure Global AI |
| China | NMPA | Registration holder | 喜客瑞士股份有限公司SIC invent AG喜客瑞士股份有限公司 SIC invent AG | 5 | — | Pure Global AI |
| Australia | TGA | Manufacturer | SIC invent AG | 4 | 2024–2024 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SIC INVENT AG | 4 | — | 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 SIC invent AG currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | 951378951416951417951422951423951424951425951426951428951429 3 more951430951431951432 | 2017 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | — | 2017 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | — | 2024 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | — | 2005 |
| Dental Implant Surgical TrayOFY · Class 1 | Implant instruments & surgical kits | Maker | — | 2024 |
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 SIC invent AG as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 3 Jun 2026 | K252904 | SIC Abutments including CAD/CAM Solutions | NHA Endosseous Dental Implant Abutment |
| 17 Mar 2022 | K210489 | SICtapered & SICvantage tapered | DZE Root-Form Endosseous Implant |
| 5 Apr 2018 | K173207 | SIC invent Dental Implant Systems | DZE Root-Form Endosseous Implant |
| 8 Aug 2006 | K061500 | SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS | DZE Root-Form Endosseous Implant |
| 13 Apr 2005 | K040757 | SIC PRO | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Imagine Milling Technologies, LLC (2).
Also lists devices cleared under other names
SIC invent AG 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: Zest Anchors, LLC (2), Dentalpoint AG (1), Tellos Medical AB (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 16 Nov 2018 | K180184 | Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System | Dentalpoint AG | NHA Endosseous Dental Implant Abutment |
| 7 Jan 2016 | K143445 | Tellos ISQ Buddy | Tellos Medical AB | EKX Ac-Powered Direct Drive Handpiece |
| 3 Dec 2007 | K072878 | MODIFICATION TO: LOCATOR IMPLANT ANCHOR | Zest Anchors, LLC | NHA Endosseous Dental Implant Abutment |
| 17 Mar 2000 | K994257 | LOCATOR IMPLANT ANCHOR | Zest Anchors, LLC | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SIC INVENT AGFDA reg. 3004443656 | Basel Town Basel-Landschaft, Switzerland | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9060857). 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.