Manufacturer registered with FDA
Zarc4Endo S.A.
GIJÓN, Spain. Lists 8 dental device types with FDA across 1 registered establishment.
- Device types listed
- 8
- Brands and models
- 42
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Spain
Devices listed with FDA
What Zarc4Endo S.A. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Lister | Z-Rinse | 2022 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Lister | Endo-Block RulerZ-Gauge Ruler | 2022 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Lister | Gutta-Percha ApicalShaperGutta-Percha BlueShaperGutta-Percha ExcaliburGutta-Percha NanoShaperGutta-Percha SlimShaperGutta-Percha Z-FitGutta-Percha Zarc | 2022 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Lister | Paper Points ApicalShaperPaper Points BlueShaperPaper Points ExcaliburPaper Points NanoShaperPaper Points SlimShaperPaper Points Z-FitPaper Points Zarc | 2022 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Lister | Z Micro-OpenerZ Micro-ShaperZ-DOWN SystemZ-UP System | 2022 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | C+ FileHedstroem FileK FileK FlexNiTi files ApicalShaperNiTi files BlueShaperNiTi files BlueShaper PRONiTi files ExcaliburNiTi files Excalibur GliderNiTi files Excalibur Glider PRO 9 moreNiTi files Excalibur PRONiTi files NanoShaperNiTi files SlimShaperNiTi files SlimShaper PRONiTi files Z-CondensorNiTi files Z-GliderNiTi files Z-Glider EVONiTi RetreatAllZ-Plugger | 2022 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | Z-EVO | 2022 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Lister | Z-Activator | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ZARC4ENDOFDA reg. 3019741877 | GIJON Asturias(Autonomous Community), Spain | Private-label distributor, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10085865). 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.