FDA.reportPublic FDA data

Touareg™ OS Zygomatic Dental Implant 4.2D 55L

Primary DI
07290109309378
Brand
Touareg™ OS Zygomatic Dental Implant 4.2D 55L
Company
ADIN DENTAL IMPLANT SYSTEMS LTD
Model
ISZT5542
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
07290109309378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109309378072901093093787290109309378

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
07290109308654Single TMA Snap-On TransferRS5012S2026-11-01
07290116770031Depth Probe, Extra Long 16-25mmRS61812026-11-01
07290116770246Single TMA Digital Model Abutment Replica, MachinedRS1001S2026-11-01
07290116770314Guided UniFit Fixture Mount Screw Retained ScrewGS50382026-11-01
07290116770383IRIS™, Burnout anti rotation cap red (4 pack)IR01852026-11-01
07290116770390IRIS™, Burnout cap white (4 pack)IR01862026-11-01
07290116777931TMA Snap-OnTMI00312026-10-26
07290116778686UF Surgical plastic kit, TrayUF63132026-10-26
07290116778709Implant ExtractorRS90502026-10-26
07290116778716TorqLine™ Implant ExtractorRS90512026-10-26
07290116778723UniFit Straight Abutment GaugeUF37102026-10-26
07290116778730UniFit Angled Abutment Gauge 17°UF37112026-10-26
07290116778747UniFit Angled Abutment Gauge 30°UF37122026-10-26
07290116778754UniFit Angled Abutment Gauge 45°UF37132026-10-26
07290116778761UniFit Angled Abutment Gauge 52°UF37142026-10-26
07290116778778UniFit Angled Abutment Gauge 60°UF37152026-10-26
07290116778785Fit Connection - Single Open Tray ImpressionFC5513S2026-10-26
07290116778792Fit Connection - Single Scan Body 6mmFC0088S2026-10-26
07290116778808Fit Connection - Single Scan Body 9mmFC0089S2026-10-26
07290116778815Fit Connection Digital ReplicaFC57382026-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800077000031ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000055ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000079ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000093ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000116ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000130ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000154ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000178ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000192ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000215ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000239ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000253ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000277ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000291ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000321ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000345ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000369ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000383ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000406ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000437ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000451ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000475ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000499ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000512ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000543ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000567ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000581ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000604ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000628ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077001038ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30