FDA.reportPublic FDA data

Touareg™ OS Zygomatic Dental Implant 4.2D 40L

Primary DI
07290109309316
Brand
Touareg™ OS Zygomatic Dental Implant 4.2D 40L
Company
ADIN DENTAL IMPLANT SYSTEMS LTD
Model
ISZT4042
Published
2026-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252031000Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.2026-03-23DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109309316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109309316072901093093167290109309316

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Regulatory Flags#

DUNS number
533289435
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290109308609Single TMA Plastic Casting Sleeve w/Prosthetic ScrewRS5001S2026-05-11
07290109308616Single TMA ReplicaRS5004S2026-05-11
07290109308647Single TMA Closed Tray TransferRS5011S2026-05-11
07290109308630Single TMA Open Tray TransferRS5006S2025-12-15
07290116778662Zygomatic Surgical Kit, Standard Hex ZGSK0012026-04-19
07290105150004Touareg CloseFit™ Plastic Surgical Kit-PremiumCF63002017-04-23
07290105150028Touareg CloseFit™ Plastic Surgical Kit-AdvancedCF63022017-04-23
07290105150035Touareg CloseFit™ Plastic Surgical Kit-StarterCF63032017-04-23
07290105150042Touareg CloseFit™ Plastic Surgical Kit-Advanced Short DrillsCF63042017-04-23
07290105150059Touareg CloseFit™ Plastic Surgical Kit-Starter Short DrillsCF63052017-04-23
07290105155429RS Angled Trans Mucosal Abutment 45° 4mmRS37362026-03-26
07290109309293Touareg™ OS Zygomatic Dental Implant 4.2D 35LISZT35422026-03-26
07290109309309Touareg™ OS Zygomatic Dental Implant 4.2D 37.5LISZT37422026-03-26
07290109309323Touareg™ OS Zygomatic Dental Implant 4.2D 42.5LISZT42422026-03-26
07290109309330Touareg™ OS Zygomatic Dental Implant 4.2D 45LISZT45422026-03-26
07290109309347Touareg™ OS Zygomatic Dental Implant 4.2D 47.5LISZT47422026-03-26
07290109309354Touareg™ OS Zygomatic Dental Implant 4.2D 50LISZT50422026-03-26
07290109309361Touareg™ OS Zygomatic Dental Implant 4.2D 52.5LISZT52422026-03-26
07290109309378Touareg™ OS Zygomatic Dental Implant 4.2D 55LISZT55422026-03-26
07290109309385Zygomatic pilot Drill 1.8/2.5mmD x 35-55mmLDL55252026-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07392532000447Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
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07392532000942Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000959Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532002731Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532002748Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532037115Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
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07392532049644Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049651Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049668Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532062841Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532036965Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532036972Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532036989Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532049576ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532049583ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532066047ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532066054ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532067778ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532067785ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532000928ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532000935ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532002649ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532002656ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532002663ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16