Manufacturer registered with FDA
Ceraroot SL
Les Franqueses del Valles, Spain. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 3
- Brands and models
- 97
- 510(k) clearances
- 12025–2025
- Markets registered in
- 417 registrations outside the US
- Establishments
- 1Spain
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name Ceraroot SL 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 | Ceraroot SL | 1 clearances | 2025–2025 | Below |
| Canada | Health Canada | Registration holder | CERAROOT SL. | 14 | 2011–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | CeraRoot SL | 2 | 2018–2018 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | CeraRoot SL | 1 | — | 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 Ceraroot SL 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 | CeraRootCeraRoot ceramic implantCeraRoot surgical kitCeraRoot zirconium oxide dental implant | 2011 |
| Preformed CrownELZ · Class 1 | — | Maker | TempCrown, Healing Rings, CeraRoot | 2020 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | bur extension -steel (00106)Bur extension -steel (AIP-3)Ceramic Tray (02004)CeraRoot Guided Surgery System (02002S)Contra Angle Driver 4x4 (ACE-8)Cortical drill guided (FAB-1707)Countersink 11 - steel (FAB-1696)Countersink 11- ceramic (00411)Countersink 11- steel (00311)Countersink 12 - steel (FAB-1878) 82 moreCountersink 14 / 34 - steel (FAB-1694)Countersink 14- ceramic (00414)Countersink 14- steel (00314)Countersink 16 - steel (FAB-1697)Countersink 16- ceramic (00416)Countersink 16- steel (00316)Countersink 21 - steel (FAB-1695)Countersink 21- ceramic (00421)Countersink 21- steel (00321)Countersink 42 - steel (FAB-1877)Cylindrical drill 2,00x10 guided (FAB-1687/02)Cylindrical drill 2,00x12 guided (FAB-1687/03)Cylindrical drill 2,00x14 guided (FAB-1687/04)Cylindrical drill 2,00x16 guided (FAB-1687/05)Cylindrical drill 2,00x18 guided (FAB-1688/01)Cylindrical drill 2,00x8 guided (FAB-1687/01)Cylindrical drill 2,80x10 guided (FAB-1687/07)Cylindrical drill 2,80x12 guided (FAB-1687/08)Cylindrical drill 2,80x14 guided (FAB-1687/09)Cylindrical drill 2,80x16 guided (FAB-1687/10)Cylindrical drill 2,80x18 guided (FAB-1688/02)Cylindrical drill 2,80x8 guided (FAB-1687/06)Cylindrical drill 3,50x10 guided (FAB-1687/12)Cylindrical drill 3,50x12 guided (FAB-1687/13)Cylindrical drill 3,50x14 guided (FAB-1687/14)Cylindrical drill 3,50x16 guided (FAB-1687/15)Cylindrical drill 3,50x18 guided (FAB-1688/03)Cylindrical drill 3,50x8 guided (FAB-1687/11)Cylindrical drill 4,20x10 guided (FAB-1687/17)Cylindrical drill 4,20x12 guided (FAB-1687/18)Cylindrical drill 4,20x14 guided (FAB-1687/19)Cylindrical drill 4,20x16 guided (FAB-1687/20)Cylindrical drill 4,20x18 guided (FAB-1688/04)Cylindrical drill 4,20x8 guided (FAB-1687/16)Fixation Pin 1.5 Guided (PIN-1)Fixation Pin drill 1.5 Guided (FIP-150G)Guided Surgical Tray (02002)Impactor for implant 14 -steel/peek (005.214)Initial bur/ positioner / triangle -steel (00101)Initial drill long guided (FAB-1706/02)Initial drill short guided (FAB-1706/01)Lab Analogue 11 (008.111)Lab Analogue 12 (008.112)Lab Analogue 14 (008.114)Lab Analogue 16 (008.116)Lab Analogue 16TL (008.162)Lab Analogue 21 (008.121)Lab Analogue 21TL (008.212)Lab Analogue 34 (008.134)Lab Analogue 34L (008.234)Lab Analogue 34TL (008.342)Lab Analogue 42 (008.142)Mallet for implant 14 -steel/plastic (005.114)Sleeve for cylindrical drill 4.25 (BDC-CR)Sleeve for fixation pin drill 1.5 (BPL-1)Steel tweezers with ceramic tip (005.500)Surgical Tray (02001)Torque Wrench Kit CeraRoot (03001)Transporter 11 -steel (00511)Transporter 11 short -ceramic (006.111)Transporter 12 -ceramic (00612)Transporter 12 -steel (00512)Transporter 16 long -ceramic (00616)Transporter 16 long -steel (00516-S)Transporter 16 long -steel (00516)Transporter 16 short -ceramic (00617)Transporter 16 short -steel (00517-S)Transporter 16 short -steel (00517)Transporter 21 -ceramic (00621)Transporter 21 -steel (00521)Transporter 34 -ceramic (00634)Transporter 34 -steel (00534)Transporter TL - steel (005.342)Transporter TL -ceramic (006.342)Twist drill 2.3 mm -ceramic (00202)Twist drill 2.3 mm -steel (00102)Twist drill 2.8 mm -ceramic (00203)Twist drill 2.8 mm -steel (00103)Twist drill 3.5 mm -ceramic (00204)Twist drill 3.5 mm -steel (00104)Twist drill 4.2 mm -ceramic (00205)Twist drill 4.2 mm -steel (00105) | 2019 |
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
Ceraroot SL 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: Oral Iceberg S.L. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 4 Jan 2011 | K093595 | CERAROOT IMPLANT SYSTEM | Oral Iceberg S.L. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CERAROOT S.L.FDA reg. 3008808095 | Les Franqueses del Valles Barcelona, Spain | Foreign exporter, Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10034855). 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.