Manufacturer registered with FDA
Uniqa Dental, Ltd.
Netanya, Israel. Lists 4 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 197
- 510(k) clearances
- 22018–2026
- Markets registered in
- 32,914 registrations outside the US
- Establishments
- 1Israel
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Uniqa Dental, Ltd. as the manufacturer or the registration holder of a device.
RegisteredHome: IsraelOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Uniqa Dental, Ltd. | 2 clearances | 2018–2026 | Below |
| European Union | EUDAMED | Manufacturer | UNIQA DENTAL LTD | 2,912 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | UNIQA DENTAL LTD | 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 Uniqa Dental, Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Conical drills with external irrigationCountersink, one sizeCountersink, two sizesDrill extenderDrill extender, internal irrigationDrill stopperDrill with integral stoppersDrills with external irrigationDrills with internal irrigationLance drill 7 moreMarking drillMarking drill, internal irrigationRound burrStep drills, coatedTissue punchTrephine burrTwist drill, coated | 2018 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Ball attachment abutmentConical Implant, Internal Hex, Pure & Porous, P&PConical Implant, Internal Hex, SBAConical Implant, Pure & Porous, P&PConical Implant, SBAHealing cap for MUA, D-typeHealing cap for Multi Unit Abutment, MUA, V-typeHealing Cap Mini/MPHealing Cap RegularHealing cap, narrow 45 moreHealing cap, regularHealing cap, wideImplant ConicalImplant Internal HexLocator abutment/DLOC attachment abutmentMetal cap for locatorMetal cap/housing for ball attachment/DLOCScrew for abutmentScrew for angled MUA, D-typeScrew for MUA sleeve, C-typeScrew for MUA sleeve, D-typeScrew for Multi Unit Abutment sleeve, V-typeScrew Mini ConicalScrew Regular ConicalSet 17 angled Multi Unit Abutment, MUA, D-type, Castable SleeveSet 17 angled Multi Unit Abutment, MUA, D-type, Temporary SleeveSet 30 angled Multi Unit Abutment, MUA, D-type, Castable SleeveSet 30 angled Multi Unit Abutment, MUA, D-type, Temporary SleeveSilicone cap for ball attachmentSilicone cap for locator/DLOC, SoftSilicone cap for locator/DLOC, StandardSilicone cap for locator/DLOC, StrongSleeve for Multi Unit Abutment, MUA, Fixed, C-typeSleeve for Multi Unit Abutment, MUA, Rotation, C-typeSleeve for Multi Unit Abutment, MUA, Temporary, D-typeSleeve for Multi Unit Abutment, MUA, Temporary, V-typeSMART Dental Implants SystemSMART Israel Dental Solutions Implants SystemSnap on transferStraight abutment with shoulder, regularStraight abutment with shoulder, wideStraight abutment, regularStraight abutment, wideStraight anatomic abutmentStraight Multi Unit Abutment, MUA, C-type/Straight multi unit abutment D-typeStraight Multi Unit Abutment, MUA, D-type/Straight multi unit abutment D-type GH- Internal Hex RPStraight Multi Unit Abutment, MUA, V-type/Straight multi unit abutment V-type GH- Internal Hex RPTransfer Abutment MiniTransfer Abutment Regular/Straight abutment RP15 angled abutment/15 abutment H- Internal Hex RP15 angled anatomic abutment/15 abutment with shoulder17 angled Multi Unit Abutment, MUA, D-type/17 multi unit abutment D-type GH- Internal Hex RP25 angled abutment/25 abutment H- Internal Hex RP25 angled anatomic abutment/25 abutment with shoulder30 angled Multi Unit Abutment, MUA, D-type/30 multi unit abutment D-type GH- Internal Hex RP | 2018 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Bite indexCap for Snap on transferCarrier for Straight MUA C-TypeCastable abutment hexCastable abutment roundCastable anatomic abutment hexCastable straight abutment hexCastable straight abutment roundClick transfer closed trayContra angle key for straight MUA C-type 60 moreContra angle key for straight MUA D-typeContra-angle driver for abutmentsContra-angle driver for implantsConvenient Surgical Kit BoxDepth probeDigital analogDigital implant analogDuplicator Dentists TransferDuplicator Dentists Transfer 1mmDuplicator Magnet CapExtractor for angled MUAHandle for Angled MUA D-TypeImplant analogImplant analog for Multi Unit Abutment MUA D-typeImplant analog for Multi Unit Abutment MUA V-typeImplant Analog Mini ConicalImplant analog plusImplant analog plus angledImplant Analog Regular ConicalImpression ring for ball attachmentImpression ring for locatorManual implant driver 6.35mmManual implant driver hexManual punch tool 4mmManual screw driver hexNut for digital analogParallel pin Double sided Long SymmetryParallel pin Double sided Short SymmetryPlastic Castable Conical Abutment MiniPlastic Castable Conical Abutment RegularRatchet key for straight MUA C-typeRatchet key for straight MUA D-typeRatchet screw driver for abutmentRatchet screw driver for implants 2.1mmRatchet screw driver for implants 2.4mmRatchet screw driver hex 1.27mmRatchet screw driver hex 2.5mmRatchet screw driver hex 2mmRatchet screw driver hex, 1.2mmRatchet wrenchScan body implant levelScrew for MUA transfer D-typeScrew for scan bodyScrew for scan body MUA levelScrew for Transfer Closed trayScrew for Transfer Open traySleeve for Multi Unit Abutment MUA Castable C-typeSleeve for Multi Unit Abutment MUA Castable D-typeSleeve for Multi Unit Abutment MUA Castable V-typeSnap on transferSurgical guide SleeveTorque ratchet wrenchTransfer closed trayTransfer closed tray wideTransfer for Multi Unit Abutment MUA D-typeTransfer for Multi Unit Abutment MUA V-typeTransfer open trayTransfer open tray narrowTransfer Open tray slimTransfer open tray wide | 2018 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Ball attachment abutmentConical Implant, Internal Hex, Pure & Porous, P&PConical Implant, Internal Hex, SBAConical Implant, Pure & Porous, P&PConical Implant, SBAHealing cap for MUA, D-typeHealing cap for Multi Unit Abutment, MUA, V-typeHealing Cap Mini/MPHealing Cap RegularHealing cap, narrow 45 moreHealing cap, regularHealing cap, wideImplant ConicalImplant Internal HexLocator abutment/DLOC attachment abutmentMetal cap for locatorMetal cap/housing for ball attachment/DLOCScrew for abutmentScrew for angled MUA, D-typeScrew for MUA sleeve, C-typeScrew for MUA sleeve, D-typeScrew for Multi Unit Abutment sleeve, V-typeScrew Mini ConicalScrew Regular ConicalSet 17 angled Multi Unit Abutment, MUA, D-type, Castable SleeveSet 17 angled Multi Unit Abutment, MUA, D-type, Temporary SleeveSet 30 angled Multi Unit Abutment, MUA, D-type, Castable SleeveSet 30 angled Multi Unit Abutment, MUA, D-type, Temporary SleeveSilicone cap for ball attachmentSilicone cap for locator/DLOC, SoftSilicone cap for locator/DLOC, StandardSilicone cap for locator/DLOC, StrongSleeve for Multi Unit Abutment, MUA, Fixed, C-typeSleeve for Multi Unit Abutment, MUA, Rotation, C-typeSleeve for Multi Unit Abutment, MUA, Temporary, D-typeSleeve for Multi Unit Abutment, MUA, Temporary, V-typeSMART Dental Implants SystemSMART Israel Dental Solutions Implants SystemSnap on transferStraight abutment with shoulder, regularStraight abutment with shoulder, wideStraight abutment, regularStraight abutment, wideStraight anatomic abutmentStraight Multi Unit Abutment, MUA, C-type/Straight multi unit abutment D-typeStraight Multi Unit Abutment, MUA, D-type/Straight multi unit abutment D-type GH- Internal Hex RPStraight Multi Unit Abutment, MUA, V-type/Straight multi unit abutment V-type GH- Internal Hex RPTransfer Abutment MiniTransfer Abutment Regular/Straight abutment RP15 angled abutment/15 abutment H- Internal Hex RP15 angled anatomic abutment/15 abutment with shoulder17 angled Multi Unit Abutment, MUA, D-type/17 multi unit abutment D-type GH- Internal Hex RP25 angled abutment/25 abutment H- Internal Hex RP25 angled anatomic abutment/25 abutment with shoulder30 angled Multi Unit Abutment, MUA, D-type/30 multi unit abutment D-type GH- Internal Hex RP | 2018 |
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 |
|---|---|---|
| UNIQA DENTAL LTDFDA reg. 3014938434 | Netanya Central, Israel | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10058710). 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.