Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007518363

FEI Number

3007518363

Entity Name

ADIN DENTAL IMPLANT SYSTEMS LTD.

City/State/Country

Afula Northern, IL

Establishment Address

Alon Tavor Industrial Zone, POB 1128, Afula Northern 1811101, IL

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

ADIN DENTAL IMPLANT SYSTEMS Ltd (Owner Number: 10028570)

Owner / Operator Contact Address

Industrial Zone, Alon Tavor, IL-Z 1811101, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212775

PMA Number

N/A

All Registered Proprietary Names

Tip Drill Guided Surgery Drills, GS Pilot Drills, Anchoring Drills Guided Surgery Drills 18mm Guided Surgery CloseFit Drills & Accessories Kit TMA Cementing Cone Ti Bases for Touareg CloseFit NP dental implants (Engaged, Non-Engaged, Angular Engaged), NP C-Type Ti Base Gold / Plastic abutments for NP (engaging and non-engaging) Healing abutments for NP (regular 4.5mmD, slim 3mmD, conical 4.5mmD) IRIS, NP Snap-on Impression Kit Cement retained abutments for NP (straight, angled 15deg, angled 25deg, temporary) Screw retained abutments for NP (Flat connection abutment 2, 4mm) Screw retained abutments for NP (Straight TMA 1-5mm, angled 17deg and 30deg) TMA components (TMA healing cap, TMA titanium temporary copying) Retaining screws for NP TMA abutments (straight and angled) Overdenture abutments for NP (Ball attachments 0.5-5mm, cylindrical grip 2-6mm) IRIS, NP Platform NP and TMA Grip Abutments Screw retained abutments for NP (straight single TMA 1-5mm, Angled single TMA 17° 3-4mm, Angled single TMA 30° 3.5-5mm) Screw retained abutments for RP and WP (Flat connection abutment 2, 4mm) Healing abutments for RS implants (Wide 6mmD, Slim 3.5mmD) Titanium / Plastic abutments for RP and WP (engaging and non-engaging) Healing Abutments for RP and WP implants (regular, slim, conical) Flat Connection system for RS implants (abutments, temporary sleeve, gluing ring, retaining screw) Overdenture abutments for RP and WP (Ball attachments 0.5-5mm, cylindrical grip 2-6mm) Touareg CloseFit RP and WP Ti Bases (Engaged, Non-Engaged, Angular Engaged), RP and WP C-Type Ti base IRIS", RP Snap-on Impression Kit Retaining screws for RP and WP TMA abutments (straight and angled) IRIS", RP Platform WP and RP Touareg CloseFit Dental Implants Swell, Touareg-S, Touareg-OS dental implants in 18mmL Screw retained abutments for RP and WP (Straight TMA 1-5mm, angled 17deg and 30deg) Titanium / Plastic abutments for RS implants (engaging and non-engaging) IRIS", WP Snap-on Impression Kit Cement retained abutments for RP and WP (straight, straight slim, angled 15deg, temporary) Overdenture abutments for RS implants (cylindrical grip 2-6mm) Cement retained abutments for RS implants (straight cylindrical, one piece screw-in, wide profile, slim 3mm, angled long IRIS", WP Platform Screw retained abutments for RP(straight single TMA 1-5mm, Angled single TMA 17° 2.5-3.5mm, Angled single TMA 30° 3-4mm) Screw retained abutments for WP(straight single TMA 1-5mm, Angled single TMA 17° 2.5-3.5mm, Angled single TMA 30° 3-4mm) Touareg OS Zygomatic Dental Implant RS Angled Trans Mucosal Abutment 45-60° Zygomatic surgical Kit, Standard Hex Tray RS Metal Surgery Kit (Small, Big) Osteotome Kit UNP Starter Surgical Package RS Internal Hex Plastic Surgical Kit (Premiu, Advanced, Starter) Adin Drill Stop Kits (Regular Long, Regular Short, Wide Long. Wide Short) Guided Surgery Kits (Drills - Basic, Accessories - RS implants) Adin Tri Step Drill Stop Kit CloseFit Metal Surgical Box (Small, Big) UniFit - Standard Internal Star Plastic Surgical Kit (Advanced, Premium) Guided Surgery Accessories Kit - UniFit Implants Screw retained abutments for UniFit dental implants (straight TMA 1-5mm, angled TMA 17-30 deg 2.5-4mm) UniFit Healing Abutment 3.5-5.5mmD 2-6mmL UniFit Retaining screws for TMA abutments (straight and angled) UniFit Overdenture abutments (Ball Attachments 0.5-5mm, Grip abutments 1-6mm) UniFit Flat Connection Abutments (2mm, 4mm) UniFit Ti Bases (Engaged, Non-Engaged, Angular Engaged), UniFit C-Type Ti Base Single TMA Cementing Cone UniFit Straight Single TMA (Straight 1-5mm, Angled 17°-30°) ADIN UNIFIT DENTAL IMPLANT SYSTEM UniFit Ti Pre Milled MDTK Abutment Blank Touareg UniFit Dental Implants ( 3.5-6mmD 6-18mmL) TMA Cementing Cone UniFit Cement retained abutments (straight, angled 15, angled 25) Open Tray Transfers, Close Tray Transfers, Screws for Transfers, Analogs, Replicas, Plastic Abutments, Casting Sleeve Scan Bodies (7mm,, 10mm). TMA Scan Bodies (6mm, 9mm), TMA Scan body Screw IRIS - Snap On Guided surgery tools, fixture mounts, sockets, ratchet, extraction tool. screw drivers, depth probe, tissue punches Guided Surgery Anchorage Screws, Sleeves Digital Analogs and Replicas Guided surgery anchorage screw Drill stoppers. handles, hex tools, core tools, hex sample, centering ring, implant carrier, handles Guided Surgery CloseFit Tools Guided Surgery CloseFit Accessories Kit Surgical Drivers, Angulated Drivers, Adapters, Parallel Pins, Depth Probe, Osteotome, Drill Extension, Ratchets, Wrench Angled Trans Mucosal Abutment Gauge Touareg OS Dental Implant Adin Dental Implants System Anatomic Abutments C-Type Ti Base Screw retained abutments for RS dental implants (connection abutments, esthetic connection abutments) Overdenture abutments (RS Ball Attachments 0.5-5mm, plastic ball caps, titanium ball cap, SS ball cap) Screw retained abutments for RS dental implants (straight TMA 1-5mm, Angled TMA 17° 2-3mm, Angled TMA 30° 3-4mm) RS Healing Abutments 4.5mmD 2-6mmL Retaining screws for TMA abutments (straight and angled) Cement retained abutments for RS dental implants (straight, slim straight, angled 15, angled 25, esthetic angled 15) IRIS, RS Platform RS Healing Abutments 3.5-6mmD 6-7mmL Touareg-S / OS implants in 3.5mmD and 8mmL RS Grip Abutments and accessories Swell, Touareg (Touareg-X), Touareg-S Implants Screw retained abutments (RS straight single TMA 1-5mm, RS Angled single TMA 17° 2-3mm, RS Angled single TMA 30° 3-4mm) Adin Short Implants

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJL	Bur, Dental	Dental	Class 1	872.3240	2011-03-15
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2014-11-10
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2014-11-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2012-06-22
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2012-06-22
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2026-03-25
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2026-03-25
OFY	Dental Implant Surgical Tray	Dental	Class 1	872.3980	2016-06-20
EGG	Attachment, Precision, All	Dental	Class 1	872.3165	2011-03-15
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-01-02
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2024-01-02
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2011-03-15
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-02-12
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2009-02-12
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-07-12

Official Correspondent

Ilana Lutvak

US Agent Details

Ksenija Batistich Business: ADIN DENTAL SOLUTIONS USA, INC. Email: ksenijab@adin-implants.com Phone: (201) 3742592

Related Public Records

Same Entity

ADIN DENTAL IMPLANT SYSTEMS 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
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007518363. Last updated year: 2026. Please use registration number 3007518363 when referencing this establishment in official correspondence.