Manufacturer registered with FDA
Jdentalcare Srl
Modena, Italy. Lists 3 dental device types with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 914
- 510(k) clearances
- 52015–2025
- Markets registered in
- 11292 registrations outside the US
- Establishments
- 1Italy
510(k) clearances per year, 2007–2026
Registered in 11 markets
Where regulators' registries name Jdentalcare Srl as the manufacturer or the registration holder of a device.
RegisteredHome: ItalyOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Jdentalcare Srl | 5 clearances | 2015–2025 | Below |
| Saudi Arabia | SFDA | Manufacturer | JDentalCare Srl | 116 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | JDENTALCARE S.R.L. | 73 | 2011–2026 | Pure Global AI |
| European Union | EUDAMED | Registration holder | J Dental Care Srl | 49 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | JDentalCare S.r.l. | 26 | 2024–2024 | Pure Global AI |
| Australia | TGA | Manufacturer | JDentalCare S.r.l. | 8 | 2020–2021 | Pure Global AI |
| Colombia | INVIMA | Registration holder | JDENTALCARE S.R.L. | 5 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | JDentalCare Srl | 5 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | JDENTALCARE S.R.LJDENTALCARE · JDentalCare S.r.l. | 5 | 2009–2024 | Pure Global AI |
| China | NMPA | Registration holder | 杰迪医疗有限公司JDentalCare S.r.l. | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | J Dental Care S.r.l.JDentalCare S.r.l. | 2 | — | 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 Jdentalcare Srl 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 | Abutment JDEvolution SAbutment JDIconAbutment JDIcon Ultra SAnatomic Abutment Angulated 15 H 1.5 JDEvolution PlusAnatomic Abutment Angulated 15 H 3 JDEvolution PlusAnatomic Abutment D 4 H 1.5 JDEvolution SAnatomic Abutment D 4 H 3 JDEvolution SAnatomic Abutment H 1.5 JDEvolution PlusAnatomic Abutment H 1.5 JDIconAnatomic Abutment H 3 JDEvolution Plus 249 moreAnatomic Abutment H 3 JDIconBall Abutment H 1.5 JDEvolution PlusBall Abutment H 1.5 JDEvolution SBall Abutment H 1.5 JDIconBall Abutment H 1.5 JDIcon Ultra SBall Abutment H 3 JDEvolution PlusBall Abutment H 3 JDEvolution SBall Abutment H 3 JDIconBall Abutment H 3 JDIcon Ultra SBall Abutment H 5 JDEvolution PlusBall Abutment H 5 JDEvolution SBall Abutment H 5 JDIconBall Abutment H 5 JDIcon Ultra SConical Abutment Angulated 17 H 2.5 JDEvolution PlusConical Abutment Angulated 17 H 3.5 JDEvolution PlusConical Abutment Angulated 30 H 2.5 JDEvolution PlusConical Abutment Angulated 30 H 3.5 JDEvolution PlusConical Abutment Angulated 45° H 4.5 JDEvolution PlusConical Abutment Angulated 52.5° H 5 JDEvolution PlusConical Abutment Angulated 60° H 5 JDEvolution PlusConical Abutment H 1.5 JDIconConical Abutment H 3 JDIconConical Abutment Straight H 1.5 JDEvolution PlusConical Abutment Straight H 2 JDEvolution PlusConical Abutment Straight H 3 JDEvolution PlusConical Abutment Straight H 4 JDEvolution PlusCover Screw JDEvolution PlusCover Screw JDEvolution SCover Screw JDIconCover Screw JDIcon Ultra SEmi Abutment H 1.5 JDEvolution PlusEmi Abutment H 1.5 JDEvolution SEmi Abutment H 1.5 JDIconEmi Abutment H 3 JDEvolution PlusEmi Abutment H 3 JDEvolution SEmi Abutment H 3 JDIconEmi Abutment H 5 JDEvolution PlusEmi Abutment H 5 JDEvolution SEmi Abutment H 5 JDIconGP Abutment 15 D 4 JDEvolution SGP Abutment D 3.2 JDEvolution SGP Abutment D 3.2 JDIcon Ultra SGP Abutment D 4 JDEvolution SGP Abutment D 4 JDIconGP Abutment D 4 JDIcon Ultra SGP Abutment D 5 JDIconGP Abutment D 6 JDIconGP Abutment Engaging D 4 JDEvolution PlusGP Abutment Engaging D 5 JDEvolution PlusGP Abutment Engaging D 6 JDEvolution PlusGP Abutment Engaging for Conical Abutment JDEvolutionGP Abutment Engaging for Conical Abutment JDEvolution PlusGP Abutment Non Engaging for Conical Abutment JDEvolutionGP Abutment Non Engaging for Conical Abutment JDEvolution PlusHealing Abutment Bridge D 5 H 3 JDIconHealing Abutment Bridge D 5 H 5 JDIconHealing Abutment Bridge D 5 H 7 JDIconHealing Abutment D 3.2 H 3 JDEvolution SHealing Abutment D 3.2 H 3 JDIcon Ultra SHealing Abutment D 3.2 H 5 JDEvolution SHealing Abutment D 3.2 H 5 JDIcon Ultra SHealing Abutment D 3.2 H 7 JDEvolution SHealing Abutment D 3.2 H 7 JDIcon Ultra SHealing Abutment D 4 H 3 JDEvolution PlusHealing Abutment D 4 H 3 JDEvolution SHealing Abutment D 4 H 3 JDIconHealing Abutment D 4 H 3 JDIcon Ultra SHealing Abutment D 4 H 5 JDEvolution PlusHealing Abutment D 4 H 5 JDEvolution SHealing Abutment D 4 H 5 JDIconHealing Abutment D 4 H 5 JDIcon Ultra SHealing Abutment D 4 H 7 JDEvolution PlusHealing Abutment D 4 H 7 JDEvolution SHealing Abutment D 4 H 7 JDIconHealing Abutment D 4 H 7 JDIcon Ultra SHealing Abutment D 5 H 3 JDEvolution PlusHealing Abutment D 5 H 3 JDIconHealing Abutment D 5 H 5 JDEvolution PlusHealing Abutment D 5 H 5 JDIconHealing Abutment D 5 H 7 JDEvolution PlusHealing Abutment D 5 H 7 JDIconHealing Abutment D 6 H 3 JDEvolution PlusHealing Abutment D 6 H 3 JDIconHealing Abutment D 6 H 5 JDEvolution PlusHealing Abutment D 6 H 5 JDIconHealing Abutment D 6 H 7 JDEvolution PlusHealing Abutment D 6 H 7 JDIconHealing Abutment D 7.5 H 3 JDEvolution PlusHealing Abutment D 7.5 H 5 JDEvolution PlusHealing Cap for Conical Abutment JDEvolutionHealing Cap for Conical Abutment JDEvolution PlusJDEvolution 3.25 Conical AbutmentsJDEvolution 3.25 GP AbutmentsJDEvolution 3.25 Prosthetic ScrewsJDEvolution Plus Anatomic AbutmentsJDEvolution Plus Conical AbutmentsJDEvolution Plus Cover ScrewsJDEvolution Plus D 3.7 L 10JDEvolution Plus D 3.7 L 11.5JDEvolution Plus D 3.7 L 13JDEvolution Plus D 3.7 L 15JDEvolution Plus D 3.7 L 8JDEvolution Plus D 4.3 L 10JDEvolution Plus D 4.3 L 11.5JDEvolution Plus D 4.3 L 13JDEvolution Plus D 4.3 L 15JDEvolution Plus D 4.3 L 8JDEvolution Plus D 5 L 10JDEvolution Plus D 5 L 11.5JDEvolution Plus D 5 L 13JDEvolution Plus D 5 L 15JDEvolution Plus D 5 L 8JDEvolution Plus D 6 L 10JDEvolution Plus D 6 L 11.5JDEvolution Plus D 6 L 13JDEvolution Plus D 6 L 15JDEvolution Plus D 6 L 8JDEvolution Plus Dental ImplantsJDEvolution Plus GP AbutmentsJDEvolution Plus Healing AbutmentsJDEvolution Plus L D 4 L 20JDEvolution Plus L D 4 L 22JDEvolution Plus L D 4 L 24JDEvolution Plus L D 4 L 26JDEvolution Plus LE D 4 L 18JDEvolution Plus LE D 4 L 20JDEvolution Plus LE D 4 L 22JDEvolution Plus LE D 4 L 24JDEvolution Plus LE D 4 L 26JDEvolution Plus Prosthetic ScrewsJDEvolution Plus Straight AbutmentsJDEvolution Plus Temporary AbutmentsJDEvolution S D 3.25 L 10JDEvolution S D 3.25 L 11.5JDEvolution S D 3.25 L 13JDEvolution S D 3.25 L 15JDEvolution S D 3.25 L 8JDIcon 2.75 Conical AbutmentsJDIcon 2.75 GP AbutmentsJDIcon Anatomic Abutments | 2016 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Abutment JDEvolution SAbutment JDIconAbutment JDIcon Ultra SAnatomic Abutment Angulated 15 H 1.5 JDEvolution PlusAnatomic Abutment Angulated 15 H 3 JDEvolution PlusAnatomic Abutment D 4 H 1.5 JDEvolution SAnatomic Abutment D 4 H 3 JDEvolution SAnatomic Abutment H 1.5 JDEvolution PlusAnatomic Abutment H 1.5 JDIconAnatomic Abutment H 3 JDEvolution Plus 240 moreAnatomic Abutment H 3 JDIconBall Abutment H 1.5 JDEvolution PlusBall Abutment H 1.5 JDEvolution SBall Abutment H 1.5 JDIconBall Abutment H 1.5 JDIcon Ultra SBall Abutment H 3 JDEvolution PlusBall Abutment H 3 JDEvolution SBall Abutment H 3 JDIconBall Abutment H 3 JDIcon Ultra SBall Abutment H 5 JDEvolution PlusBall Abutment H 5 JDEvolution SBall Abutment H 5 JDIconBall Abutment H 5 JDIcon Ultra SConical Abutment Angulated 17 H 2.5 JDEvolution PlusConical Abutment Angulated 17 H 3.5 JDEvolution PlusConical Abutment Angulated 30 H 2.5 JDEvolution PlusConical Abutment Angulated 30 H 3.5 JDEvolution PlusConical Abutment Angulated 45° H 4.5 JDEvolution PlusConical Abutment Angulated 52.5° H 5 JDEvolution PlusConical Abutment Angulated 60° H 5 JDEvolution PlusConical Abutment H 1.5 JDIconConical Abutment H 3 JDIconConical Abutment Straight H 1.5 JDEvolution PlusConical Abutment Straight H 2 JDEvolution PlusConical Abutment Straight H 3 JDEvolution PlusConical Abutment Straight H 4 JDEvolution PlusCover Screw JDEvolution PlusCover Screw JDEvolution SCover Screw JDIconCover Screw JDIcon Ultra SEmi Abutment H 1.5 JDEvolution PlusEmi Abutment H 1.5 JDEvolution SEmi Abutment H 1.5 JDIconEmi Abutment H 3 JDEvolution PlusEmi Abutment H 3 JDEvolution SEmi Abutment H 3 JDIconEmi Abutment H 5 JDEvolution PlusEmi Abutment H 5 JDEvolution SEmi Abutment H 5 JDIconGP Abutment 15 D 4 JDEvolution SGP Abutment D 3.2 JDEvolution SGP Abutment D 3.2 JDIcon Ultra SGP Abutment D 4 JDEvolution SGP Abutment D 4 JDIconGP Abutment D 4 JDIcon Ultra SGP Abutment D 5 JDIconGP Abutment D 6 JDIconGP Abutment Engaging D 4 JDEvolution PlusGP Abutment Engaging D 5 JDEvolution PlusGP Abutment Engaging D 6 JDEvolution PlusGP Abutment Engaging for Conical Abutment JDEvolutionGP Abutment Engaging for Conical Abutment JDEvolution PlusGP Abutment Non Engaging for Conical Abutment JDEvolutionGP Abutment Non Engaging for Conical Abutment JDEvolution PlusHealing Abutment Bridge D 5 H 3 JDIconHealing Abutment Bridge D 5 H 5 JDIconHealing Abutment Bridge D 5 H 7 JDIconHealing Abutment D 3.2 H 3 JDEvolution SHealing Abutment D 3.2 H 3 JDIcon Ultra SHealing Abutment D 3.2 H 5 JDEvolution SHealing Abutment D 3.2 H 5 JDIcon Ultra SHealing Abutment D 3.2 H 7 JDEvolution SHealing Abutment D 3.2 H 7 JDIcon Ultra SHealing Abutment D 4 H 3 JDEvolution PlusHealing Abutment D 4 H 3 JDEvolution SHealing Abutment D 4 H 3 JDIconHealing Abutment D 4 H 3 JDIcon Ultra SHealing Abutment D 4 H 5 JDEvolution PlusHealing Abutment D 4 H 5 JDEvolution SHealing Abutment D 4 H 5 JDIconHealing Abutment D 4 H 5 JDIcon Ultra SHealing Abutment D 4 H 7 JDEvolution PlusHealing Abutment D 4 H 7 JDEvolution SHealing Abutment D 4 H 7 JDIconHealing Abutment D 4 H 7 JDIcon Ultra SHealing Abutment D 5 H 3 JDEvolution PlusHealing Abutment D 5 H 3 JDIconHealing Abutment D 5 H 5 JDEvolution PlusHealing Abutment D 5 H 5 JDIconHealing Abutment D 5 H 7 JDEvolution PlusHealing Abutment D 5 H 7 JDIconHealing Abutment D 6 H 3 JDEvolution PlusHealing Abutment D 6 H 3 JDIconHealing Abutment D 6 H 5 JDEvolution PlusHealing Abutment D 6 H 5 JDIconHealing Abutment D 6 H 7 JDEvolution PlusHealing Abutment D 6 H 7 JDIconHealing Abutment D 7.5 H 3 JDEvolution PlusHealing Abutment D 7.5 H 5 JDEvolution PlusHealing Cap for Conical Abutment JDEvolutionHealing Cap for Conical Abutment JDEvolution PlusJDEvolution 3.25 Conical AbutmentsJDEvolution 3.25 GP AbutmentsJDEvolution 3.25 Prosthetic ScrewsJDEvolution Plus Anatomic AbutmentsJDEvolution Plus Conical AbutmentsJDEvolution Plus Cover ScrewsJDEvolution Plus D 3.7 L 10JDEvolution Plus D 3.7 L 11.5JDEvolution Plus D 3.7 L 13JDEvolution Plus D 3.7 L 15JDEvolution Plus D 3.7 L 8JDEvolution Plus D 4.3 L 10JDEvolution Plus D 4.3 L 11.5JDEvolution Plus D 4.3 L 13JDEvolution Plus D 4.3 L 15JDEvolution Plus D 4.3 L 8JDEvolution Plus D 5 L 10JDEvolution Plus D 5 L 11.5JDEvolution Plus D 5 L 13JDEvolution Plus D 5 L 15JDEvolution Plus D 5 L 8JDEvolution Plus D 6 L 10JDEvolution Plus D 6 L 11.5JDEvolution Plus D 6 L 13JDEvolution Plus D 6 L 15JDEvolution Plus D 6 L 8JDEvolution Plus Dental ImplantsJDEvolution Plus GP AbutmentsJDEvolution Plus Healing AbutmentsJDEvolution Plus Prosthetic ScrewsJDEvolution Plus Straight AbutmentsJDEvolution Plus Temporary AbutmentsJDEvolution S D 3.25 L 10JDEvolution S D 3.25 L 11.5JDEvolution S D 3.25 L 13JDEvolution S D 3.25 L 15JDEvolution S D 3.25 L 8JDIcon 2.75 Conical AbutmentsJDIcon 2.75 GP AbutmentsJDIcon Anatomic AbutmentsJDIcon Conical AbutmentsJDIcon D 3.9 L 10JDIcon D 3.9 L 11.5JDIcon D 3.9 L 13JDIcon D 3.9 L 15JDIcon D 4.3 L 10JDIcon D 4.3 L 11.5JDIcon D 4.3 L 13JDIcon D 4.3 L 15 | 2016 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Abutment Removal Driver L 27 JDIcon PlusAbutment Removal Driver L 34 JDIcon PlusAbutment replica conical abutmentAbutment Retrieval Tool JDIconAngulated Screw Driver for Conical Abutment Direct JDTorque L 25Angulated Screw Driver for Conical Abutment Direct JDTorque L 30Angulated Screw Driver for JDTorque L 25Angulated Screw Driver for JDTorque L 30Ball Abutment Elastic Retention Cap w ContainerBall Abutment Replica 395 moreBall Abutment Retention CapBone Mill D 5 and Guide JDEvolution PlusBone Mill D 5 and Guide JDEvolution SBone Mill D 5 and Guide JDIcon PlusBone Mill D 6 and Guide JDEvolution PlusBone Mill D 6 and Guide JDEvolution SBone Mill D 6 and Guide JDIcon PlusBone Mill Guide JDEvolution PlusBone Mill Guide JDEvolution SBone Mill Guide JDIcon PlusCentering Device JDEvolutionClaw DrillCobalt-Chrome Abutment Engaging JDEvolutionCobalt-Chrome Abutment Engaging JDIcon PlusCobalt-Chrome Abutment Engaging JDIcon Ultra SCobalt-Chrome Abutment Non Engaging JDEvolutionCobalt-Chrome Abutment Non Engaging JDIcon PlusCobalt-Chrome Conical Abutment Non Engaging JDEvolutionCobalt-Chrome Conical Abutment Non Engaging JDEvolution PlusConical Abutment Aligning Instrument JDEvolutionConical Abutment Aligning Instrument JDEvolution PlusConical Abutment Aligning Instrument JDEvolution SConical Abutment Aligning Instrument JDIcon PlusConical Abutment DriverConical Abutment Driver for JDTorqueConical Abutment Healing Cap Peek JDEvolutionConical Abutment Impression Coping Engaging Open Tray JDEvolution PlusConical Abutment Impression Coping Open Tray Engaging JDEvolutionConical Abutment Impression Coping Open Tray JDEvolutionConical Abutment Impression Coping Open Tray Long JDEvolutionConical Abutment Impression Coping Open Tray Long JDEvolution PlusConical Abutment MINI Impression Coping Engaging Open TrayConical Abutment MINI Impression Coping Engaging Open Tray JDEvolution PlusConical Abutment MINI Impression Coping Open TrayConical Abutment MINI Impression Coping Open Tray JDEvolution PlusConical Abutment MINI ReplicaConical Abutment MINI Replica CAD CAMConical Abutment Replica CAD CAM NewConometric Abutment Impression Coping PEEKConometric Abutment ReplicaDental Implant Depth ProbeDiamond DrillDiamond Drill D 3.2Diamond Drill D 3.7Diamond Drill D 4.3Diamond Drill D 5Diamond Drill Long JDZygomaDirection IndicatorDirection Indicator 17Direction Indicator 30Direction Indicator 45Direction Indicator for JDOD32Direction Indicator for JDOD37Direction Indicator for JDOD43Direction Indicator for JDOD50Direction Indicator ShortDrill D 2 JDNasalDrill D 2 JDPterygoDrill D 2.4 JDNasalDrill D 2.8 JDPterygoDrill D 2.8 JDZygomaDrill D 3.2 JDPterygoDrill D 3.2 JDZygomaDrill D 3.6 JDZygomaDrill ExtensionDrill Stop D 2Drill Stop D 2.4Drill Stop D 2.8Drill Stop D 3.2Drill Stop D 3.6Drill Stop D 4Drill Stop D 4.4Drill Stop D 4.8Drill Stop New L 10Drill Stop New L 11.5Drill Stop New L 13Drill Stop New L 15Drill Stop New L 6Drill Stop New L 8Driver Body for Guided SurgeryEmi Abutment ContainerEmi Abutment Elastic Retention Cap (1.2 kg)Emi Abutment Elastic Retention Cap w ContainerEmi Abutment Plastic Impression CopingEmi Abutment Purple Retention Cap (2.5 kg)Emi Abutment ReplicaEmi Abutment Retention Cap for LaboratoryEmi Abutment Steel Impression CopingEmi Abutment White Retention Cap (1.8 kg)Emi Abutment Yellow Retention Cap (0.6 kg)Extractor-insertion Tool For CapsGold Abutment Engaging JDIconGold Abutment Non Engaging JDIconGuided Drill D 2 L 10Guided Drill D 2 L 11.5Guided Drill D 2 L 13Guided Drill D 2 L 15Guided Drill D 2 L 18Guided Drill D 2 L 20Guided Drill D 2 L 22Guided Drill D 2 L 24Guided Drill D 2 L 26Guided Drill D 2 L 6Guided Drill D 2 L 8Guided Drill D 2.4 L 10Guided Drill D 2.4 L 11.5Guided Drill D 2.4 L 13Guided Drill D 2.4 L 15Guided Drill D 2.4 L 18Guided Drill D 2.4 L 20Guided Drill D 2.4 L 22Guided Drill D 2.4 L 24Guided Drill D 2.4 L 26Guided Drill D 2.4 L 6Guided Drill D 2.4 L 8Guided Drill D 2.8 L 10Guided Drill D 2.8 L 11.5Guided Drill D 2.8 L 13Guided Drill D 2.8 L 15Guided Drill D 2.8 L 6Guided Drill D 2.8 L 8Guided Drill D 3.2 L 10Guided Drill D 3.2 L 11.5Guided Drill D 3.2 L 13Guided Drill D 3.2 L 15Guided Drill D 3.2 L 6Guided Drill D 3.2 L 8Guided Drill D 3.6 L 10Guided Drill D 3.6 L 11.5Guided Drill D 3.6 L 13Guided Drill D 3.6 L 15Guided Drill D 3.6 L 6Guided Drill D 3.6 L 8Guided Drill D 4.2 L 10Guided Drill D 4.2 L 11.5Guided Drill D 4.2 L 13Guided Drill D 4.2 L 15Guided Drill D 4.2 L 6Guided Drill D 4.2 L 8Guided Mounter Removal Screw | 2016 |
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 Jdentalcare Srl as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 25 Sep 2025 | K251148 | JDEvolution Plus L and JDEvolution Plus LE | DZE Root-Form Endosseous Implant |
| 11 Oct 2024 | K240143 | JDZygoma dental implants | DZE Root-Form Endosseous Implant |
| 16 Aug 2024 | K233896 | JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus | DZE Root-Form Endosseous Implant |
| 26 Jun 2020 | K182081 | JDentalCare Implant System JDIcon | DZE Root-Form Endosseous Implant |
| 6 Nov 2015 | K143142 | JDENTALCARE Implant System | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| J DENTAL CARE SRLFDA reg. 3013264549 | Modena, Italy | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10052880). 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.