FDA.reportPublic FDA data

TRI

Primary DI
07640149884678
Brand
TRI
Company
TRI Dental Implants Int. AG
Model
A
Catalog number
TN10-35-F
Published
2019-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151916000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151916000TRI Dental Implant SystemTri Dental Implants Int. AG2015-12-18DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640149884678PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640149884678076401498846787640149884678

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+80033133313info@tri-implants.swiss

Regulatory Flags#

DUNS number
485821164
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640149886726TRIDM-Analog-P372026-10-06
07640149886733TRIDM-Analog-5-P372026-10-06
07640149886740TRIAM-SCRW-ASC2026-10-06
07640149886757TRIAM-SCRW-ASC-Lab-52026-10-06
07640149886764TRIAM-ET-ASC2026-10-06
07640149886771TRIBM-SCRW-2.8-L-62026-10-06
07640149886788TRIAM-SCRW-ASC-62026-10-06
07640149886702TRICM-IR-A-P372026-07-07
07640149886719TRICM-IR-A-P452026-07-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
088000968612008plant Implant System8dent Inc.NHA2026-10-29
088000968612178plant Implant System8dent Inc.NHA2026-10-29
088000968612248plant Implant System8dent Inc.NHA2026-10-29
088000968582488plant Implant System8dent Inc.NHA2026-10-28
088000968583238plant Implant System8dent Inc.NHA2026-10-28
088000968583308plant Implant System8dent Inc.NHA2026-10-28
088000968583548plant Implant System8dent Inc.NHA2026-10-28
088000968583618plant Implant System8dent Inc.NHA2026-10-28
088000968583928plant Implant System8dent Inc.NHA2026-10-28
088000968585218plant Implant System8dent Inc.NHA2026-10-28
088000968585388plant Implant System8dent Inc.NHA2026-10-28
088000968585458plant Implant System8dent Inc.NHA2026-10-28
088000968585698plant Implant System8dent Inc.NHA2026-10-28
088000968585768plant Implant System8dent Inc.NHA2026-10-28
088000968585838plant Implant System8dent Inc.NHA2026-10-28
088000968586068plant Implant System8dent Inc.NHA2026-10-28
088000968586138plant Implant System8dent Inc.NHA2026-10-28
088000968586208plant Implant System8dent Inc.NHA2026-10-28
088000968587508plant Implant System8dent Inc.NHA2026-10-28
088000968601668plant Implant System8dent Inc.NHA2026-10-28
088000968604018plant Implant System8dent Inc.NHA2026-10-28
088000968604258plant Implant System8dent Inc.NHA2026-10-28
088000968604328plant Implant System8dent Inc.NHA2026-10-28
088000968604568plant Implant System8dent Inc.NHA2026-10-28
088000968604638plant Implant System8dent Inc.NHA2026-10-28
088000968650488plant Implant System8dent Inc.NHA2026-10-28
088000968650558plant Implant System8dent Inc.NHA2026-10-28
088000968650628plant Implant System8dent Inc.NHA2026-10-28
08809984971922S-PlantIDIS CO.,LTDNHA2026-10-26
10841307136378Simply Iconic™ ImplantIMPLANT DIRECT SYBRON MANUFACTURING LLCDZE2026-10-26