Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005663340

FEI Number

3005663340

Entity Name

A.B. DENTAL DEVICES LTD

City/State/Country

Ashdod Southern, IL

Establishment Address

19 Hayahalomim st., Ashdod Southern 77609, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

A.B. DENTAL DEVICES LTD (Owner Number: 9085481)

Owner / Operator Contact Address

19 Hayahalomim st., Ashdod, IL-NOTA 77609, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Long Drill D3.65 L40mm Hand Dynamic Driver L15mm Driver for installing I-On implant through AB Guide P24 Scan Body L12mm Implant mount for guided kit L9mm CP Long Drill D2.3 L40mm Long Drill D2.8 L40mm Long Drill D3.2 L40mm Diamond Ball Burr,D4.2,L30mm Implant Mount Screw L15mm SP Implant Mount Screw L9mm NP Implant Contra Angle Driver without spring L20mm SP ABGuide Tapered Drill D4,L16mm Implant mount for guided kit L13mm CP ABGuide Straight Drill D2,L6mm ABGuide Bone Mill D5.5mm Conical Platform Post For Bone Mill Pin Conical Platform ABGuide Straight Drill D2,L11.5mm ABGuide Tapered Drill D4,L6mm ABGuide Pilot Drill D2.2,L4.7mm,Offset 13mm Long Extension For Ratchet for AB Fully Guided Surgery Kit Step Drill for Zygoma (1) D2/2.5/3,L60mm Implant mount for guided kit L11mm CP ABGuide Tapered Drill D3.65,L11.5mm ABGuide Tapered Drill D3.2,L6mm Step Drill for Zygoma (3) D2.8/3.2,L80mm P64 Scan Body L12mm ABGuide Bone Mill D5.5mm Internal Hex ABGuide Tapered Drill D3.2,L16mm Implant Mount Screw L15mm CP Drill D1.5mm L9mm with stopper Implant Mount Screw L13mm CP Driver for P16P64 MU L13mm Implant Driver Wrench Adapter without spring L9mm NP ABGuide Pilot Drill D2.2,L4.7mm,Offset 11mm Extraction screw for Implant mount,L15mm Sleeve ring for splint fixation,D1.5/2.9mm H8mm Drill D1.5mm L5mm with stopper Fully Guided Implant Mount Extension Surgical Kit TDSD-2.8 Coated Step Drill D2.8mm TDSD-3.65 Coated Step Drill D3.65mm TDSD-5.5 Coated Step Drill D5.5mm TDSD-3.2 Coated Step Drill D3.2mm TDSD-5 Coated Step Drill D5mm TDSD-4.5 Coated Step Drill D4.5mm TDSD-4 Coated Step Drill D4mm TDSD-2.5 Coated Step Drill D2.5mm Coated Step Drill D3.2mm Ratchet Hex Driver for Abutment Guide Drill D2.8mm L25mm Medium Organizer Kit without Irrigation SD-CP Ring For Splint Green TRS D4.5/5.1 H3.5 Guide Drill D3.2mm L21mm Coated Step Drill D5.5mm Compact Organized Kit SD-CP Dynamic Screwdriver for handpiece length L25mm Driver for I6 Implants Tapered Screw for template 19mm Medium Organizer Kit without Irrigation - Full Driver for installing the implant through AB Guide Handle for AB Guide 3.65mm Diameter Hand Dynamic Driver L15mm Coated Drill extension Ring For Splint Blue TR D2/3 Surgical Box for 30 Conical Drills Conical Drilling - 2 Ratchet Hex Driver for Implant Conical Drills Kit Pilot Drill Abutment Gripper Implant Motor Driver L25mm Conical Platform Implant removing tool Depth Gauge Contra angle driver for fixation screws length25 Tool For Sinus lift Tango-I2 D4.2 L13mm Guide Drill D2mm L25mm Guide Drill D3.65mm L17mm Rings For Splint 100Units TR D2/5.1 Implant mount for guide d kit L9mm CP Screw removing instrument - standard platform Coated Drill -4 Retrieving screw Narrow Platform Ring for Splint Guide Drill D2mm L17mm Ring For Splint Red TR D2/3 Full Hex driver D2.1 L18mm for Conical platform Tapered screw for template 13mm AB Guided Surgical Box Implant Ratchet Hex Driver L9mm Conical Platform Guide Drill D3.2mm L17mm Coated Step Drill D5mm Compact Surgical Box Ring For Splint Yellow TRS D4.5/5.1 H3.5 Guide Drill D2.5mm L17mm Guide Drill D3.65mm L25mm Handle Guide Drill D2mm L30mm Guide Drill D3.65mm L21mm Pilot Coated Drill -2 Ring For Splint TR D4.5/5.1 ABGuide Tapered Drill D3.65,L13mm ABGuide Straight Drill D2,L8mm Implant mount for guided kit L11mm SP Contra Angle Driver For Abutment Coated Step Drill D4mm Technician's Handle Ratchet Wrench Coated Step Drill D3.65mm Ratchet Hex Driver for Abutment L21mm Retrieval Screw Conical Platform Contra Angle Driver for implant Screw Removing instrument - conical Platform Ratchet-Torque Combination Depth Probe ABGuide Straight Drill D2,L13mm Implant mount for guided kit L9mm NP ABGuide Tapered Drill D4,L10mm ABGuide Tapered Drill D2.8,L13mm ABGuide Tapered Drill D2.5,L13mm Guide Drill D3.65mmL30mm Handle Fixation Screw Fully Guided Surgery Kit AB Guided Surgical Kit Implant Ratchet Hex Driver L18mm Conical Platform Implant mount for guided kit L11mm NP ABGuide Tapered Drill D4,L11.5mm Implant Mount Screw L13mm SP ABGuide Tapered Drill D3.2,L8mm Motor Trx Driver for ASC L20mm ABGuide Tapered Drill D2.8,L16mm Compact Organized with Coated Step Drills Guide Drill D3.2mm L25mm Step Drill for Zygoma (1) D2/2.5/3,L40mm Trephine Marker Drill ABGuide Tapered Drill D2.8,L8mm Hand Hex Driver for Abutment Step Drill for Zygoma (2) D2.8/3.2,L80mm Motor Adaptor For AB Fully Guided Surgery Kit ABGuide Tapered Drill D4,L8mm ABGuide Tapered Drill D2.5,L8mm ABGuide Tapered Drill D3.2,L10mm Implant mount for guided kit L9mm SP Short Extension For Ratchet AB Fully Guided Surgery Kit Motor Trx Driver for ASC L25mm ABGuide Tapered Drill D2.5,L11.5mm Hand Trx Driver for ASC L15mm Implant Mount Screw L13mm NP Drill Handle for AB Guide 2mm Diameter Ring For Splint Blue TR D4.5/5.1 ABGuide Tapered Drill D3.65,L8mm ABGuide Tapered Drill D2.8,L10mm ABGuide Tapered Drill D2.8,L6mm Coated Step Drill D2.5mm Fixation Screw driver insert 30Lmm Guide Drill D2.8mm L30mm Coated Step Drill D4.5mm Compact Organized Kit Ring For Splint Red TRS D4.5/5.1 H3.5 Implant Mount Screw L15mm NP Step Drill for Zygoma (3) D2.8/3.2,L40mm Hand Trx Driver for ASC L9mm Diamond Burr D4.2,L30mm Fine,Red Tissue Punch D4.4,L9mm Diamond Burr D4.2,L30mm Coarse, Blue ABGuide Tapered Drill D3.65,L10mm ABGuide Straight Drill D2,L16mm ABGuide Tapered Drill D2.8,L11.5mm Step Drill for Zygoma (1) D2/2.5/3,L80mm Implant mount for guided kit L13mm NP Coated Step Drill D2.8mm Screwdriver handle,plastic rotatable,with hexcoupling Guide Drill D2mm L21mm Guide Drill D3.2mm L30mm Ring For Splint Yellow TR D2/3 Implant mount for guide d kit L15mm CP Drill D1.5mm L13mm with stopper Hexagonal Ring head for Splint,D5/6mm H4mm Guide Drill D2.8mm L21mm Step Drills Medium Organized Kit Ring For Splint Blue TRS D4.5/5.1 H3.5 Implant Mount Screw L11mm SP Implant Mount Screw L11mm NP Coated Drill -2.5 Guide Drill D2.5mm L30mm Medium Organizer Kit without Irrigation Handle for AB Guide 3.2mm Diameter Ring For Splint Yellow TR D4.5/5.1 Implant Contra Angle Driver without spring L20mm NP Implant Driver Wrench Adapter without spring L18mm NP Guide Drill Ring For Splint Green TR D2/3 ABGuide Straight Drill D2,L10mm Impression Transfer for I6B Implant Implant Contra Angle Driver without spring L25mm SP Counter Sink Guide Drill D2.5mm L21mm Handle for AB Guide 2.5mm Diameter Ring For Splint Green TR D4.5/5.1 Implant Driver Wrench Adapter without spring L9mm SP Conical Stopper Drill Guide Drill D2.5mm L25mm Handle for AB Guide 2.8mm Diameter Ring For Splint Red TR D4.5/5.1 Drill D1.5mm L11mm with stopper ABGuide Tapered Drill D3.2,L13mm Implant Contra Angle Driver without spring L25mm CP Implant mount for guided kit L15mm SP ABGuide Tapered Drill D3.65,L16mm Screw removing instrument - narrow platform Coated Drill -3.65 Retrieving Screw Parallel Pin Implant Driver Wrench Adapter without spring L18mm CP Contra angle driver for fixation screws length20 Tool For Sinus lift Tango-I2 D3.75 L13mm Coated Drill -2.8 Guide Drill D2.8mm L17mm Coated Drills Medium Organized Kit Driver for installing I-On implant through AB Guide Screwdriver Blade,self-holding,cross drive Coated Drill -3.2 Medium Surgical Box Driver for installing 3mm implant through AB Guide Fixation Pin Zygomatic Implant Surgical Kit Implant Driver Wrench Adapter without spring L9mm CP Implant Mount Screw L9mm SP Head Fluted Ball Burr ABGuide Tapered Drill D4,L13mm Drill D1.5mm L7mm with stopper Implant Contra Angle Driver without spring L25mm NP Extraction screw for Implant mount,L11mm Implant Driver Wrench Adapter without spring L18mm SP Step Drill for Zygoma (3) D2.8/3.2,L60mm Ratchet-Torque Combination Quad head 10-40 Ncm Implant mount for guided kit L13mm SP ABGuide Pilot Drill D2.2,L4.7mm,Offset 15mm ABGuide Tapered Drill D3.2,L11.5mm Post For Bone Mill Pin Standard Platform Implant mount for guided kit L15mm NP ABGuide Tapered Drill D2.5,L16mm Ratchet Trx Driver for ASC L15mm ABGuide Tapered Drill D3.65,L6mm Step Drill for Zygoma (2) D2.8/3.2,L40mm ABGuide Tapered Drill D2.5,L6mm Ratchet Trx Driver for ASC L21mm Short Drill ABGuide Tapered Drill D2.5,L10mm Step Drill for Zygoma (2) D2.8/3.2,L60mm Post For Bone Mill Pin Narrow Platform ABGuide Pilot Drill D2.2,L4.7mm Implant Mount Screw L11mm CP Implant Mount Screw L9mm CP Anatomic Angular Abutment for I6B Implant set Ball Attachment for I6B Implant -a+b+c I6B Narrow Implant, 3 mm, 3.2 mm I2 Screw Type Implant, 3.5 mm Anti-rotation Abutment for I6B Implant I6 Narrow Integral Implant, 2.4 mm, 3 mm, 3.2 mm Angular Adaptor 30 set Ball Attachment Abutment - a+ b+c Titanium Sleeve for Angular Adaptor Gold Sleeve for Angular Adaptor Low Connector Diameter 3.75 Locator® Width 3.75 Protective disk for Low Connector I5 Conical Implant, 3.5 mm Anti-rotation Aesthetic Abutment Locator® Extended Range Male Processing Package Zirconium Anatomic Abutment Wide Anti-rotation Abutment - Perfect Fit Narrow Anti-rotation Abutment- Perfect Fit Angular Adaptor 17 Locator® Male Processing Package Assembly Anatomic Angular Abutment 15º with Shoulder - Perfect Fit Silicon Cap hard for Low Connector Titanium Sleeve without Hex Temporary PEEK Anatomic Anti-rotation Abutment Long Angular Abutment 15º - Perfect Fit Healing Cap for I6-B Implant Ball for Angular Adaptor ( b+c) I6BI Narrow Implant, 3 mm Anti-rotation Abutment - Perfect Fit I6b Ball Attachment Implant, 2.4 mm set Angular Ball Attachment 20º Metal Cap for Low Connector Composed Hex Abutment GOLD Composed NOT Hex Abutment A.B. DENTAL DEVICES Dental Implants System A.B. Dental Device, Ltd. AB Dental Devices Dental Implants Plastic Snap Transfer kit for P64 Narrow Impression Transfer for closed tray Plastic Sleeve w/Fixation Screw-Straight w/Hex P64 Model Analog Short Digital Analog for P24 MU Lower screw for Angular Adaptor P14C-4 Scan Body Plastic sleeve for Angular Adaptor Plastic Snap Transfer Kit for P24 MU Cone carrier Long Plastic sleeve for Flat Connection Abutment Driver for P24 Straight MU L6mm Impression Transfer Open tray for single crown P14C MU Impression Transfer Open Tray Conical Platform Plastic Snap Transfer Kit for P14C-4 P14/P16 Scan Body Digital Analog for P24 MU Scan Abutment Standard Platform Long Scan Abutment Standard Platform Handle Plastic sleeve P24 MU Implant Model Analog Conical Platform Scan Abutment Narrow Platform P14 Model Analog Impression Transfer Open Tray P14C-4 Platform P14Cb Plastic Sleeve P24 Scan Body Long Impression Transfer Closed Tray Conical Platform P64 Scan Body Analog for Angular Adaptor 17+30 Protective disk Long Scan Abutment Conical Platform Impression Transfer Closed Tray Conical Platform Plastic Conical Sleeve Transfer for Angular Adaptor Handle Fixation Screw Impression Transfer P14C Analog Long Impression Transfer Open Tray Conical Platform Analog for P24 Abutments Impression Transfer Screw for Angular Adaptor Plastic Sleeve w/Fixation Screw-Rounded Transfer Screw Conical Platform Short fixing screw Impression Transfer Open Tray For P24 MU Wide Clip Transfer Narrow Impression Transfer for open tray P14C-4 Anti-Rotaition Scan Body Long Transfer Screw Conical Platform P14-4 Model Analog Body Impression Transfer for open tray Long Scan Abutment Narrow Platform Long Driver for P24 Straight MU L10mm Plastic Transfer Long Open Tray Impression Transfer Screw Conical Platform Gold Sinus Lift Instrument Light Blue Sinus Lift Instrument Red Sinus Lift Instrument Pink Sinus Lift Instrument Purple Sinus Lift Instrument Silver Sinus Lift Instrument Black Sinus Lift Instrument Green Sinus Lift Instrument

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2024-08-12
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2020-04-27
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2014-02-12
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2014-02-12
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-08-20
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-12-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-11-20
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2006-04-05
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2017-09-25
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-09-25
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2013-06-28
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-06-28
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2024-04-10
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2018-03-20

Official Correspondent

No official correspondent registered.

US Agent Details

Alan Schwartz Email: alan@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

A.B. DENTAL DEVICES LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14
K903999	O Co., Inc.	OBUTMENT HB	1992-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Z-0029-05	Implant Innovations, Inc.	2	EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005663340. Last updated year: 2026. Please use registration number 3005663340 when referencing this establishment in official correspondence.