FDA Registration
Active
🇮🇱 Israel
ADIN DENTAL IMPLANT SYSTEMS LTD.
Reg #: 3007518363
·
FEI: 3007518363
·
Expires 2026
Products
9
Proprietary Names
109
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- ADIN DENTAL IMPLANT SYSTEMS LTD.
- Registration Number
- 3007518363
- FEI Number
- 3007518363
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Alon Tavor Industrial Zone, POB 1128
- City
- Afula Northern
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K140293
Owner / Operator
- Firm Name
- ADIN DENTAL IMPLANT SYSTEMS Ltd
- Operator Number
- 10028570
- Address
- Industrial Zone
- City
- Alon Tavor
- State
- Northern
- Postal Code
- 1811101
- Country
- IL
- Correspondent
- Ilana Lutvak
US Agent
- Business Name
- ADIN DENTAL SOLUTIONS USA, INC.
- Contact Name
- Ksenija Batistich
- Address
- 560 Sylvan Avenue, Suite 3160
- City
- Englewd Clfs
- State
- NJ
- ZIP
- 07632
- Country
- US
- [email protected]
- Phone
- 201 3742592
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bur, Dental | EJL | Class 1 | Dental | No | 2011-03-15 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2014-11-10 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2014-11-10 |
| Dental Implant Surgical Tray | OFY | Class 1 | Dental | No | 2016-06-20 |
| Attachment, Precision, All | EGG | Class 1 | Dental | No | 2011-03-15 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2011-03-15 |
| Dental Abutment Design Software For Dental Laboratory | PNP | Class 2 | Dental | No | 2025-11-18 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2014-04-30 |
| Controller, Foot, Handpiece And Cord | EBW | Class 1 | Dental | No | 2015-02-23 |
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)
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
TOUAREG CloseFit UNP 2.75mmD implants
Ti Bases for Touareg CloseFit UNP dental implants (Engaged, Non-Engaged, Angular Engaged), UNP C-Type Ti Base
IRIS, UNP Snap-on Impression Kit
IRIS, UNP Platform
Cement retained abutments for UNP (straight, straight slim, angled 15deg, temporary, one piece screw-in)
Healing abutments for UNP (regular 4mmD, slim 2.75mmD, conical 4mmD)
Overdenture abutments for UNP (Ball attachments 0.5-5mm)
UNP CloseFit Ti Pre Milled MDTK Abutment Blank
RP CloseFit Ti Pre Milled MDTK Abutment Blank
WP CloseFit Ti Pre Milled MDTK Abutment Blank
RS CloseFit Ti Pre Milled MDTK Abutment Blank
Ti Base RS Abutment
NP CloseFit Ti Pre Milled MDTK Abutment Blank
Ti Base UniFit Abutment
Prosthetic Kit Metal, Prosthetic kit tray
x-cube
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device