FDA.reportPublic FDA data

TRI

Primary DI
07640149888270
Brand
TRI
Company
TRI Dental Implants Int. AG
Model
A
Catalog number
XFSK-Tray
Published
2025-11-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
07640149888270PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640149888270076401498882707640149888270

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant 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 typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
485821164
Device count
1
Premarket exempt
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
07640149885194TRIAM-P45-Shaper2026-04-14
07640149885200TRIAGD-Bone Clearance2026-04-14
07640149885217TRIEPD-L-ANG2026-03-31
07640149885224TRIEMD-S-ISO2026-02-24
07640149885231TRIEMD-L-ISO2026-02-24
07640149885248TRIEMD-S-TW2026-02-24
07640149885255TRIEMD-L-TW2026-02-24
07640149888386TRIDXFM-33-08-P372026-02-24
07640149888393TRIDXFM-33-10-P372026-02-24
07640149888409TRIDXFM-33-12-P372026-02-24
07640149888416TRIDXFM-33-14-P372026-02-24
07640149888423TRIDXFM-33-16-P372026-02-24
07640149888447TRIDXFM-37-08-P372026-02-24
07640149888454TRIDXFM-37-10-P372026-02-24
07640149888461TRIDXFM-37-12-P372026-02-24
07640149888478TRIDXFM-37-14-P372026-02-24
07640149888485TRIDXFM-37-16-P372026-02-24
07640149888522TRIDXFM-37-06-P452026-02-24
07640149888539TRIDXFM-37-08-P452026-02-24
07640149888546TRIDXFM-37-10-P452026-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290116778662Zygomatic Surgical Kit, Standard Hex ADIN DENTAL IMPLANT SYSTEMS LTDOFY2026-04-19
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
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