FDA.reportPublic FDA data

Zygomatic Surgical Kit, Standard Hex

Primary DI
07290116778662
Brand
Zygomatic Surgical Kit, Standard Hex
Company
ADIN DENTAL IMPLANT SYSTEMS LTD
Model
ZGSK001
Published
2026-04-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OFYDental Implant Surgical Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFYDental Implant Surgical TrayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290116778662PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290116778662072901167786627290116778662

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, reusableA collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
533289435
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
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
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
07290109309316Touareg™ OS Zygomatic Dental Implant 4.2D 40LISZT40422026-03-26
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
07290116770369Zygomatic surgical Kit, Standard Hex – TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2026-03-26
07290109308630Single TMA Open Tray TransferADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290109309927Guided Surgery Drills TRAYADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116770000Guided Surgery Accessories TRAY– UNP&NPADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116770017Guided Surgery Accessories TRAY - RS ImplantsADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116770024Guided Surgery Accessories TRAY– RP&WPADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116770291Guided Surgery Accessories KIT - UniFit Implants, TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116772769Bone Autografting Master Kit TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116772776Bone Autografting Master SS Kit TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116772783OsseoSave Master NC Kit TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116772790OsseoSave Master Kit TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116775494SafeDepth TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-01
07290116776507SS SafeDepth TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-01
07290116776514 SafeDepth Kit ADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-01
07290116776521SS SafeDepth Kit ADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-01
07290116772967Bone Autografting Master SS Kit ADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-11-26
07290116773124OsseoSave Master Kit ADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-11-26
07290116773285OsseoSave Master NC Kit ADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-11-26
07290116772806Bone Autografting Master KitADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-11-25
07640149888270TRITRI Dental Implants Int. AGOFY2025-11-10
07640149888324TRITRI Dental Implants Int. AGOFY2025-11-10
08435389826576COMPLETE SURGICAL BOX ADVANCED KITBIOTECHNOLOGY INSTITUTE SLOFY2025-04-14
08435389828945STOP & GUIDE KIT; INTERNA IMPLANT; 3.0 PLATFORMBIOTECHNOLOGY INSTITUTE SLOFY2025-04-14
08809918259980Surgical Option KitOssvis Co., Ltd.OFY2025-02-25
08435451660466KLOCKNERSOADCO, S.L.OFY2025-02-14
08435451660473KLOCKNERSOADCO, S.L.OFY2025-02-14
08435451660480KLOCKNERSOADCO, S.L.OFY2025-02-14
08809918259959Surgical Master Kit2Ossvis Co., Ltd.OFY2024-11-22
08809918259928Surgical Simple Kit2Ossvis Co., Ltd.OFY2024-10-25
08809918273634Surgical Simple Kit3Ossvis Co., Ltd.OFY2024-10-25