Manufacturer registered with FDA
A.B. Dental Devices , Ltd.
Ashdod, Israel. Lists 7 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 7
- Brands and models
- 855
- 510(k) clearances
- 42006–2026
- Markets registered in
- 545 registrations outside the US
- Establishments
- 1Israel
510(k) clearances per year, 2000–2026
Registered in 5 markets
Where regulators' registries name A.B. Dental Devices , 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 | A.B. Dental Devices , Ltd. | 4 clearances | 2006–2026 | Below |
| Taiwan | TFDA | Manufacturer | AB DENTAL DEVICES LIMITEDA.B. DENTAL DEVICES LIMITED · AB Dental Devices Ltd. · +1 | 27 | 2008–2022 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | AB DENTAL DEVICES LTDAB DENTAL DEVICES LTD. | 9 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | AB Dental DevicesA.B. DENTAL DEVICES · A.B.Dental Devices Ltd · +1 | 6 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | A.B. DENTAL DEVICES LTD. | 3 | 2025–2025 | 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 A.B. Dental Devices , 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 |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | A.B. DENTAL DEVICES Dental Implants SystemAB Dental Devices Dental ImplantsAB LOC H1mm Conical PlatformAB LOC H2mm Conical PlatformAB LOC H3mm Conical PlatformAB LOC H4mm Conical PlatformAB LOC H5mm Conical PlatformAB LOC H6mm Conical PlatformAbutment PreFace D11.9mm Conical PlatformAbutment PreFace D11.9mm Narrow Platform 195 moreAbutment PreFace D11.9mm Standard PlatformAbutment Screw Conical PlatformAnatomic Angular Abutment 15º with Shoulder - Perfect FitAnatomic Angular Abutment for I6B ImplantAngular Abutment 15º Conical PlatformAngular Abutment 25º Conical PlatformAngular Adaptor 17Angular Adaptor 30Angular adaptor single unitAngular MU P24 17° GH2mm Standard PlatformAngular MU P24 17° GH3mm Standard PlatformAngular MU P24 17° GH4mm Standard PlatformAngular MU P24 17° GH5mm Standard PlatformAngular MU P24 30° GH2mm Standard PlatformAngular MU P24 30° GH3mm Standard PlatformAngular MU P24 30° GH4mm Standard PlatformAngular MU P24 30° GH5mm Standard PlatformAngular Screw Retained Abutment 17° H1 Conical PlatformAngular Screw Retained Abutment 17° H1 Narrow PlatformAngular Screw Retained Abutment 17° H2 Conical PlatformAngular Screw Retained Abutment 17° H2 Narrow PlatformAngular Screw Retained Abutment 17° H3 Conical PlatformAngular Screw Retained Abutment 17° H3 Narrow PlatformAngular Screw Retained Abutment 30° H1 Conical PlatformAngular Screw Retained Abutment 30° H1 Narrow PlatformAngular Screw Retained Abutment 30° H2 Conical PlatformAngular Screw Retained Abutment 30° H2 Narrow PlatformAngular Screw Retained Abutment 30° H3 Conical PlatformAngular Screw Retained Abutment 30° H3 Narrow PlatformAnti-rotation Abutment - Perfect FitAnti-rotation Abutment for I6B ImplantAnti-rotation Aesthetic AbutmentBall for Angular Adaptor ( b+c)Base for Angular adaptor single unit 17-4Base for Angular adaptor single unit 30-4Base for Angular adaptor single unit 30-5Composed Hex AbutmentConical head screw for MultiunitConical Implant D3.75mm L18mmConical Implant D3mm, L10mmConical Implant D3mm, L11.5mmConical Implant D3mm, L13mmConical Implant D3mm, L16mmConical Implant D4.2mm L18mmConical Implant D4.5mm, L6mmConical Implant D5mm, L6mmConical Implant D6mm, L6mmCortical Implant D4mm L10mmCortical Implant D4mm L11.5mmCortical Implant D4mm L13mmCortical Implant D4mm L16mmCortical Implant D4mm L18mmCortical Implant D4mm L20mmCortical Implant D5mm L10mmCortical Implant D5mm L11.5mmCortical Implant D5mm L13mmCortical Implant D5mm L16mmCortical Implant D6mm L10mmCortical Implant D6mm L11.5mmCortical Implant D6mm L13mmCortical Implant D6mm L16mmCover Screw Conical PlatformDynamic Screw for AbutmentGOLD Composed NOT Hex AbutmentGold Sleeve for Angular AdaptorHealing Cap D4.5mm GH1.5mm AH2.5mm Conical PlatformHealing Cap D4.5mm GH2.5mm AH2.5mm Conical PlatformHealing Cap D4.5mm GH3.5mm AH2.5mm Conical PlatformHealing Cap D4.8mm GH1mm AH3mm Conical PlatformHealing Cap D4.8mm GH2mm AH3mm Conical PlatformHealing Cap D4.8mm GH3mm AH3mm Conical PlatformHealing Cap D4.8mm GH4mm AH3mm Conical PlatformHealing Cap D4.8mm GH5mm AH3mm Conical PlatformHealing Cap D5.3mm GH1mm AH3mm Conical PlatformHealing Cap D5.3mm GH2mm AH3mm Conical PlatformHealing Cap D5.3mm GH3mm AH3mm Conical PlatformHealing Cap D5.3mm GH4mm AH3mm Conical PlatformHealing Cap D5.3mm GH5mm AH3mm Conical PlatformHealing Cap D5.5mm GH2mm AH2.5mm Conical PlatformHealing Cap D5.8mm GH3mm AH2.5mm Conical PlatformHealing Cap D5.8mm GH4mm AH2.5mm Conical PlatformHealing Cap for I6-B ImplantHealling Cap for P24 MUI-ON Implant D3.5mm L10mm Conical PlatformI-ON Implant D3.5mm L11.5mm Conical PlatformI-ON Implant D3.5mm L13mm Conical PlatformI-ON Implant D3.5mm L16mm Conical PlatformI-ON Implant D3.75mm L10mm Conical PlatformI-ON Implant D3.75mm L11.5mm Conical PlatformI-ON Implant D3.75mm L13mm Conical PlatformI-ON Implant D3.75mm L16mm Conical PlatformI-ON Implant D3.75mm L8mm Conical PlatformI-ON Implant D4.2mm L10mm Conical PlatformI-ON Implant D4.2mm L11.5mm Conical PlatformI-ON Implant D4.2mm L13mm Conical PlatformI-ON Implant D4.2mm L16mm Conical PlatformI-ON Implant D4.2mm L6mm Conical PlatformI-ON Implant D4.2mm L8mm Conical PlatformI-ON Implant D5mm L10mm Conical PlatformI-ON Implant D5mm L11.5mm Conical PlatformI-ON Implant D5mm L13mm Conical PlatformI-ON Implant D5mm L6mm Conical PlatformI-ON Implant D5mm L8mm Conical PlatformI2 Screw Type Implant, 3.5 mmI5 Conical Implant, 3.5 mmI6 Narrow Integral Implant, 2.4 mm, 3 mm, 3.2 mmI6b Ball Attachment Implant, 2.4 mmI6B Narrow Implant, 3 mm, 3.2 mmI6BI Narrow Implant, 3 mmImplant Cover screw D3.75mmImplant Cover screw D3mmLocator Extended Range Male Processing PackageLocator Male Processing PackageLocator® Extended Range Male Processing PackageLocator® Male Processing Package AssemblyLocator® Width 3.75Long Angular Abutment 15º - Perfect FitLong Angular Abutment 15º Conical PlatformLong Angular Abutment 25º Conical PlatformLong narrow angular Abutment 15º standard platformLong narrow angular Abutment 25º standard platformLow Connector Diameter 3.75Lower screw for Angular AdaptorMetal CapMetal Cap for Low ConnectorNarrow Anti-rotation Abutment- Perfect FitOne Piece Implant D3.3mm L10mmOne Piece Implant D3.3mm L11.5mmOne Piece Implant D3.3mm L13mmOne Piece Implant D3.3mm L16mmOne Piece Implant D3.3mm L6mmOne Piece Implant D3.3mm L8mmOne Piece Implant D3.75mm L10mmOne Piece Implant D3.75mm L11.5mmOne Piece Implant D3.75mm L13mmOne Piece Implant D3.75mm L16mmOne Piece Implant D3.75mm L6mmOne Piece Implant D3.75mm L8mmOne Piece Implant D4.2mm L10mmOne Piece Implant D4.2mm L11.5mm | 2013 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | A.B. Dental Device, Ltd.AB Dental Devices Dental ImplantsAB LOC H1mm Conical PlatformAB LOC H2mm Conical PlatformAB LOC H3mm Conical PlatformAB LOC H4mm Conical PlatformAB LOC H5mm Conical PlatformAB LOC H6mm Conical PlatformAbutment PreFace D11.9mm Conical PlatformAbutment PreFace D11.9mm Narrow Platform 195 moreAbutment PreFace D11.9mm Standard PlatformAbutment Screw Conical PlatformAnatomic Angular Abutment 15º with Shoulder - Perfect FitAnatomic Angular Abutment for I6B ImplantAngular Abutment 15º Conical PlatformAngular Abutment 25º Conical PlatformAngular Adaptor 17Angular Adaptor 30Angular adaptor single unitAngular MU P24 17° GH2mm Standard PlatformAngular MU P24 17° GH3mm Standard PlatformAngular MU P24 17° GH4mm Standard PlatformAngular MU P24 17° GH5mm Standard PlatformAngular MU P24 30° GH2mm Standard PlatformAngular MU P24 30° GH3mm Standard PlatformAngular MU P24 30° GH4mm Standard PlatformAngular MU P24 30° GH5mm Standard PlatformAngular Screw Retained Abutment 17° H1 Conical PlatformAngular Screw Retained Abutment 17° H1 Narrow PlatformAngular Screw Retained Abutment 17° H2 Conical PlatformAngular Screw Retained Abutment 17° H2 Narrow PlatformAngular Screw Retained Abutment 17° H3 Conical PlatformAngular Screw Retained Abutment 17° H3 Narrow PlatformAngular Screw Retained Abutment 30° H1 Conical PlatformAngular Screw Retained Abutment 30° H1 Narrow PlatformAngular Screw Retained Abutment 30° H2 Conical PlatformAngular Screw Retained Abutment 30° H2 Narrow PlatformAngular Screw Retained Abutment 30° H3 Conical PlatformAngular Screw Retained Abutment 30° H3 Narrow PlatformAnti-rotation Abutment - Perfect FitAnti-rotation Abutment for I6B ImplantAnti-rotation Aesthetic AbutmentBall for Angular Adaptor ( b+c)Base for Angular adaptor single unit 17-4Base for Angular adaptor single unit 30-4Base for Angular adaptor single unit 30-5Composed Hex AbutmentConical head screw for MultiunitConical Implant D3.75mm L18mmConical Implant D3mm, L10mmConical Implant D3mm, L11.5mmConical Implant D3mm, L13mmConical Implant D3mm, L16mmConical Implant D4.2mm L18mmConical Implant D4.5mm, L6mmConical Implant D5mm, L6mmConical Implant D6mm, L6mmCortical Implant D4mm L10mmCortical Implant D4mm L11.5mmCortical Implant D4mm L13mmCortical Implant D4mm L16mmCortical Implant D4mm L18mmCortical Implant D4mm L20mmCortical Implant D5mm L10mmCortical Implant D5mm L11.5mmCortical Implant D5mm L13mmCortical Implant D5mm L16mmCortical Implant D6mm L10mmCortical Implant D6mm L11.5mmCortical Implant D6mm L13mmCortical Implant D6mm L16mmCover Screw Conical PlatformDynamic Screw for AbutmentGOLD Composed NOT Hex AbutmentGold Sleeve for Angular AdaptorHealing Cap D4.5mm GH1.5mm AH2.5mm Conical PlatformHealing Cap D4.5mm GH2.5mm AH2.5mm Conical PlatformHealing Cap D4.5mm GH3.5mm AH2.5mm Conical PlatformHealing Cap D4.8mm GH1mm AH3mm Conical PlatformHealing Cap D4.8mm GH2mm AH3mm Conical PlatformHealing Cap D4.8mm GH3mm AH3mm Conical PlatformHealing Cap D4.8mm GH4mm AH3mm Conical PlatformHealing Cap D4.8mm GH5mm AH3mm Conical PlatformHealing Cap D5.3mm GH1mm AH3mm Conical PlatformHealing Cap D5.3mm GH2mm AH3mm Conical PlatformHealing Cap D5.3mm GH3mm AH3mm Conical PlatformHealing Cap D5.3mm GH4mm AH3mm Conical PlatformHealing Cap D5.3mm GH5mm AH3mm Conical PlatformHealing Cap D5.5mm GH2mm AH2.5mm Conical PlatformHealing Cap D5.8mm GH3mm AH2.5mm Conical PlatformHealing Cap D5.8mm GH4mm AH2.5mm Conical PlatformHealing Cap for I6-B ImplantHealling Cap for P24 MUI-ON Implant D3.5mm L10mm Conical PlatformI-ON Implant D3.5mm L11.5mm Conical PlatformI-ON Implant D3.5mm L13mm Conical PlatformI-ON Implant D3.5mm L16mm Conical PlatformI-ON Implant D3.75mm L10mm Conical PlatformI-ON Implant D3.75mm L11.5mm Conical PlatformI-ON Implant D3.75mm L13mm Conical PlatformI-ON Implant D3.75mm L16mm Conical PlatformI-ON Implant D3.75mm L8mm Conical PlatformI-ON Implant D4.2mm L10mm Conical PlatformI-ON Implant D4.2mm L11.5mm Conical PlatformI-ON Implant D4.2mm L13mm Conical PlatformI-ON Implant D4.2mm L16mm Conical PlatformI-ON Implant D4.2mm L6mm Conical PlatformI-ON Implant D4.2mm L8mm Conical PlatformI-ON Implant D5mm L10mm Conical PlatformI-ON Implant D5mm L11.5mm Conical PlatformI-ON Implant D5mm L13mm Conical PlatformI-ON Implant D5mm L6mm Conical PlatformI-ON Implant D5mm L8mm Conical PlatformI2 Screw Type Implant, 3.5 mmI5 Conical Implant, 3.5 mmI6 Narrow Integral Implant, 2.4 mm, 3 mm, 3.2 mmI6b Ball Attachment Implant, 2.4 mmI6B Narrow Implant, 3 mm, 3.2 mmI6BI Narrow Implant, 3 mmImplant Cover screw D3.75mmImplant Cover screw D3mmLocator Extended Range Male Processing PackageLocator Male Processing PackageLocator® Extended Range Male Processing PackageLocator® Male Processing Package AssemblyLocator® Width 3.75Long Angular Abutment 15º - Perfect FitLong Angular Abutment 15º Conical PlatformLong Angular Abutment 25º Conical PlatformLong narrow angular Abutment 15º standard platformLong narrow angular Abutment 25º standard platformLow Connector Diameter 3.75Lower screw for Angular AdaptorMetal CapMetal Cap for Low ConnectorNarrow Anti-rotation Abutment- Perfect FitOne Piece Implant D3.3mm L10mmOne Piece Implant D3.3mm L11.5mmOne Piece Implant D3.3mm L13mmOne Piece Implant D3.3mm L16mmOne Piece Implant D3.3mm L6mmOne Piece Implant D3.3mm L8mmOne Piece Implant D3.75mm L10mmOne Piece Implant D3.75mm L11.5mmOne Piece Implant D3.75mm L13mmOne Piece Implant D3.75mm L16mmOne Piece Implant D3.75mm L6mmOne Piece Implant D3.75mm L8mmOne Piece Implant D4.2mm L10mmOne Piece Implant D4.2mm L11.5mm | 2006 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | AB Guided Surgical BoxAB Guided Surgical KitABGuide Bone Mill D5.5mm Conical PlatformABGuide Bone Mill D5.5mm Internal HexABGuide Pilot Drill D2.2,L4.7mmABGuide Pilot Drill D2.2,L4.7mm,Offset 11mmABGuide Pilot Drill D2.2,L4.7mm,Offset 13mmABGuide Pilot Drill D2.2,L4.7mm,Offset 15mmABGuide Straight Drill D2,L10mmABGuide Straight Drill D2,L11.5mm 237 moreABGuide Straight Drill D2,L13mmABGuide Straight Drill D2,L16mmABGuide Straight Drill D2,L6mmABGuide Straight Drill D2,L8mmABGuide Tapered Drill D2.5,L10mmABGuide Tapered Drill D2.5,L11.5mmABGuide Tapered Drill D2.5,L13mmABGuide Tapered Drill D2.5,L16mmABGuide Tapered Drill D2.5,L6mmABGuide Tapered Drill D2.5,L8mmABGuide Tapered Drill D2.8,L10mmABGuide Tapered Drill D2.8,L11.5mmABGuide Tapered Drill D2.8,L13mmABGuide Tapered Drill D2.8,L16mmABGuide Tapered Drill D2.8,L6mmABGuide Tapered Drill D2.8,L8mmABGuide Tapered Drill D3.2,L10mmABGuide Tapered Drill D3.2,L11.5mmABGuide Tapered Drill D3.2,L13mmABGuide Tapered Drill D3.2,L16mmABGuide Tapered Drill D3.2,L6mmABGuide Tapered Drill D3.2,L8mmABGuide Tapered Drill D3.65,L10mmABGuide Tapered Drill D3.65,L11.5mmABGuide Tapered Drill D3.65,L13mmABGuide Tapered Drill D3.65,L16mmABGuide Tapered Drill D3.65,L6mmABGuide Tapered Drill D3.65,L8mmABGuide Tapered Drill D4,L10mmABGuide Tapered Drill D4,L11.5mmABGuide Tapered Drill D4,L13mmABGuide Tapered Drill D4,L16mmABGuide Tapered Drill D4,L6mmABGuide Tapered Drill D4,L8mmAbutment GripperCoated Drill -2.5Coated Drill -2.8Coated Drill -3.2Coated Drill -3.65Coated Drill -4Coated Drill extensionCoated Drills Medium Organized KitCoated Step Drill D2.5mmCoated Step Drill D2.8mmCoated Step Drill D3.2mmCoated Step Drill D3.65mmCoated Step Drill D4.5mmCoated Step Drill D4mmCoated Step Drill D5.5mmCoated Step Drill D5mmCompact Organized KitCompact Organized Kit SD-CPCompact Organized with Coated Step DrillsCompact Surgical BoxConical Drilling - 2Conical Drills KitConical Stopper DrillContra Angle Driver For AbutmentContra angle driver for fixation screws length20Contra angle driver for fixation screws length25Contra Angle Driver for implantCounter SinkDepth GaugeDepth ProbeDiamond Ball Burr,D4.2,L30mmDiamond Burr D4.2,L30mm Coarse, BlueDiamond Burr D4.2,L30mm Fine,RedDrillDrill D1.5mm L11mm with stopperDrill D1.5mm L13mm with stopperDrill D1.5mm L5mm with stopperDrill D1.5mm L7mm with stopperDrill D1.5mm L9mm with stopperDriver for I6 ImplantsDriver for installing 3mm implant through AB GuideDriver for installing I-On implant through AB GuideDriver for installing the implant through AB GuideDriver for P16P64 MU L13mmDynamic Screwdriver for handpiece length L25mmExtraction screw for Implant mount,L11mmExtraction screw for Implant mount,L15mmFixation PinFixation Screw driver insert 30LmmFull Hex driver D2.1 L18mm for Conical platformFully Guided Implant Mount Extension Surgical KitFully Guided Surgery KitGuide DrillGuide Drill D2.5mm L17mmGuide Drill D2.5mm L21mmGuide Drill D2.5mm L25mmGuide Drill D2.5mm L30mmGuide Drill D2.8mm L17mmGuide Drill D2.8mm L21mmGuide Drill D2.8mm L25mmGuide Drill D2.8mm L30mmGuide Drill D2mm L17mmGuide Drill D2mm L21mmGuide Drill D2mm L25mmGuide Drill D2mm L30mmGuide Drill D3.2mm L17mmGuide Drill D3.2mm L21mmGuide Drill D3.2mm L25mmGuide Drill D3.2mm L30mmGuide Drill D3.65mm L17mmGuide Drill D3.65mm L21mmGuide Drill D3.65mm L25mmGuide Drill D3.65mmL30mmHand Dynamic Driver L15mmHand Hex Driver for AbutmentHand Trx Driver for ASC L15mmHand Trx Driver for ASC L9mmHandleHandle Fixation ScrewHandle for AB Guide 2.5mm DiameterHandle for AB Guide 2.8mm DiameterHandle for AB Guide 2mm DiameterHandle for AB Guide 3.2mm DiameterHandle for AB Guide 3.65mm DiameterHead Fluted Ball BurrHexagonal Ring head for Splint,D5/6mm H4mmImplant Contra Angle Driver without spring L20mm NPImplant Contra Angle Driver without spring L20mm SPImplant Contra Angle Driver without spring L25mm CPImplant Contra Angle Driver without spring L25mm NPImplant Contra Angle Driver without spring L25mm SPImplant Driver Wrench Adapter without spring L18mm CPImplant Driver Wrench Adapter without spring L18mm NPImplant Driver Wrench Adapter without spring L18mm SPImplant Driver Wrench Adapter without spring L9mm CPImplant Driver Wrench Adapter without spring L9mm NPImplant Driver Wrench Adapter without spring L9mm SPImplant Motor Driver L25mm Conical PlatformImplant mount for guide d kit L15mm CPImplant mount for guide d kit L9mm CPImplant mount for guided kit L11mm CPImplant mount for guided kit L11mm NPImplant mount for guided kit L11mm SPImplant mount for guided kit L13mm CPImplant mount for guided kit L13mm NPImplant mount for guided kit L13mm SP | 2020 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Analog for Angular Adaptor 17+30Analog for P24 AbutmentsCone carrier LongDigital Analog for P24 MUDriver for P24 Straight MU L6mmHandleHandle Fixation ScrewImplant Model Analog Conical PlatformImpression TransferImpression Transfer Closed Tray Conical Platform 45 moreImpression Transfer for open trayImpression Transfer Open Tray Conical PlatformImpression Transfer Open Tray For P24 MUImpression Transfer Open tray for single crown P14C MUImpression Transfer Open Tray P14C-4 PlatformImpression Transfer Screw for Angular AdaptorLong Driver for P24 Straight MU L10mmLong Impression Transfer Closed Tray Conical PlatformLong Impression Transfer Open Tray Conical PlatformLong Open Tray Impression Transfer Screw Conical PlatformLong Scan Abutment Conical PlatformLong Scan Abutment Narrow PlatformLong Scan Abutment Standard PlatformLong Transfer Screw Conical PlatformLower screw for Angular AdaptorNarrow Impression Transfer for closed trayNarrow Impression Transfer for open trayP14 Model AnalogP14-4 Model Analog BodyP14/P16 Scan BodyP14C AnalogP14C-4 Anti-Rotaition Scan BodyP14C-4 Scan BodyP14Cb Plastic SleeveP24 Scan BodyP64 Model AnalogP64 Scan BodyPlastic Conical SleevePlastic sleeve for Angular AdaptorPlastic sleeve for Flat Connection AbutmentPlastic sleeve P24 MUPlastic Sleeve w/Fixation Screw-RoundedPlastic Sleeve w/Fixation Screw-Straight w/HexPlastic Snap Transfer Kit for P14C-4Plastic Snap Transfer Kit for P24 MUPlastic Snap Transfer kit for P64Plastic TransferProtective diskScan Abutment Narrow PlatformScan Abutment Standard PlatformShort Digital Analog for P24 MUShort fixing screwTransfer for Angular AdaptorTransfer Screw Conical PlatformWide Clip Transfer | 2024 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Driver for installing I-On implant through AB GuideHand Dynamic Driver L15mmImplant mount for guided kit L9mm CPLong Drill D2.3 L40mmLong Drill D2.8 L40mmLong Drill D3.2 L40mmLong Drill D3.65 L40mmP24 Scan Body L12mm | 2024 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | Black Sinus Lift InstrumentGold Sinus Lift InstrumentGreen Sinus Lift InstrumentLight Blue Sinus Lift InstrumentPink Sinus Lift InstrumentPurple Sinus Lift InstrumentRed Sinus Lift InstrumentSilver Sinus Lift Instrument | 2018 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | A.B. Dental Devices, Ltd.ABGuideAbutment GripperAdapter RatchetAnalogAnalog for P14Analog for P24Analog for P64Analog for P6HClip Transfer 117 moreClip Transfer with conical platformCoated Drill BitCompact Organized Conical KitCompact Organized Conical Kit - EmptyCompact Organized KitCompact Organized Kit - EmptyConical Drill BitConical Stopper Drill BitContra Angle DriverContra Angle Driver for abutmentContra Angle Driver for implantCounter sinkDepth GaugeDrill bitDrilling Extension BitDriver for installing the implant through AB GuideFlexible driverGuide Drill BitGUIDE Fixation Screw (5 Units) D-2, L-11GUIDE Fixation Screw (5 Units) D-2, L-13GUIDE Fixation Screw (5 Units) D-2, L-7GUIDE Fixation Screw (5 Units) D-2, L-9GUIDE Fixation Screw (5 Units) D-2.3, L-11GUIDE Fixation Screw (5 Units) D-2.3, L-13GUIDE Fixation Screw (5 Units) D-2.3, L-7GUIDE Fixation Screw (5 Units) D-2.3, L-9GUIDE Fixation screw D-1.5,L-6.5GUIDE Fixation screw D-1.5,L-8GUIDE Fixation screw D-1.8,L-6.5GUIDE Fixation screw D-1.8,L-8guideded surgical kitHand Hex DriverHand Hex Driver for AbutmentHand Hex Driver for P6HandleHandle Diameter 2.5mmHandle Diameter 2.8mmHandle Diameter 2mmHandle Diameter 3.2mmHandle Diameter 3.65mmImplant AnalogImplant Analog for I6Implant Analog for I6bImplant positionImplant removing kitImplant removing tool - narrow platformImplant removing tool - standard platformImpression Transfer for Angular AdaptorImpression Transfer for Angular Adaptor Single UnitImpression Transfer for closed tray for conical platformImpression transfer for closed traysImpression Transfer for Flat Connection AbutmentImpression Transfer for Flat Connection Abutment for customized implantImpression Transfer for I6 ImplantImpression Transfer for One Piece Angular AdaptorImpression transfer for open trayImpression Transfer for open tray for conical platformImpression Transfer for P6HLong Cone CarrierLong DrillMalletmanual adapterManual Adaptor for DriverMarker Drill BitMedium Organizer Conical KitMedium Organizer KitMetal CapNarrow Clip TransferNarrow Clip Transfer with conical platformNarrow Impression Transfer for Flat Connection AbutmentNarrow Impression Transfer for open trayP14C-a Cone CarrierP2 AbutmentPackage of Plastic Snaps Transfer with Abutment 10 unitsParallel PinPilot Coated Drill BitPilot Drill BitPilot Short Drill BitPin fixationPlastic Conical Sleeve without Hex (Blue)Plastic Conical Sleeve without Hex (Red)Plastic snap transfer with abutmentPlastic Snap Transfer without abutmentPlastic TransferProtective diskPunch for cutting gumsRatched Torque WrenchRatchet Hex driverRatchet Hex Driver for AbutmentRatchet Hex Driver for I6BRatchet Hex Driver for ImplantRatchet Hex Driver for P6Ratchet Torque CombinationRatchet WrenchRetrieving screwScrew removing instrument kitScrew removing instrument kit narrow platformScrew removing instrument kits standard platformShort Drill BitShort fixing screwSilicone CapSilicone cap extended range setSilicone Cap hardSilicone Cap mediumSilicone cap setSilicone Cap softStopper Drill Bitstopper sleeveStoppered Conical Drill KitStoppered Drill KitTapTapered screw for templateTapered Screw for template 19mmTechnician's HandleTissue Punch DriverTrephineWide Clip Transfer | 2006 |
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 A.B. Dental Devices , Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 18 Jun 2026 | K250806 | Dental Implant System | DZE Root-Form Endosseous Implant |
| 21 Jan 2014 | K132125 | A.B. DENTAL DEVICES DENTAL IMPLANTS SYSTEM | DZE Root-Form Endosseous Implant |
| 18 Apr 2012 | K112440 | AB DENTAL DEVICES IMPLANTS AND ACCESSORIES | DZE Root-Form Endosseous Implant |
| 21 Mar 2006 | K051719 | A.B. DENTAL DEVICES | DZE Root-Form Endosseous Implant |
Also lists devices cleared under other names
A.B. Dental Devices , Ltd. 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: A.B. Dental Device , Ltd. (4).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 23 Sep 2022 | K202144 | A.B. Dental Devices Dental Implants System | A.B. Dental Device , Ltd. | NHA Endosseous Dental Implant Abutment |
| 15 Jul 2019 | K182455 | A.B. DENTAL DEVICES Dental Implants System | A.B. Dental Device , Ltd. | NHA Endosseous Dental Implant Abutment |
| 23 Nov 2018 | K181381 | A.B. Dental Devices Dental Implants System | A.B. Dental Device , Ltd. | NHA Endosseous Dental Implant Abutment |
| 15 Sep 2017 | K162482 | A.B. DENTAL DEVICES Dental Implants System | A.B. Dental Device , Ltd. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| A.B. DENTAL DEVICES LTDFDA reg. 3005663340 | Ashdod Southern, Israel | Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9085481). 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.