FDA Registration Active 🇮🇱 Israel

TOUAREG CloseFit™ UNP 2.75mmD implants

Reg #: 3007518363 · FEI: 3007518363 · Expires 2025
Products
2
Proprietary Names
8
Establishment Types
1
Classifications
2

Registration Details

Registration Name
ADIN DENTAL IMPLANT SYSTEMS LTD.
Registration Number
3007518363
FEI Number
3007518363
Status
Active
Expiry Year
2025
Initial Importer
No
Address
Alon Tavor Industrial Zone, POB 1128
City
Afula Northern
Country
IL

Regulatory Submissions

510(k) Number
K153111

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
Phone
201 3742592

Products

Device Name Product Code
Implant, Endosseous, Root-Form DZE
Abutment, Implant, Dental, Endosseous NHA

Proprietary Names

TOUAREG CloseFit™ UNP 2.75mmD implants Ti Bases for Touareg CloseFit UNP dental implants (Engaged, Non-Engaged, Angular Engaged), UNP C-Type Ti Base 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 IRIS™, UNP Snap-on Impression Kit Cement retained abutments for UNP (straight, straight slim, angled 15deg, temporary, one piece screw-in) IRIS™, UNP Platform

Establishment Types

Manufacture Medical Device