FDA.reportPublic FDA data

TRI

Primary DI
07640149884944
Brand
TRI
Company
TRI Dental Implants Int. AG
Model
A
Catalog number
TN10-41-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
07640149884944PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640149884944076401498849447640149884944

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126046871ET III Fixture SA Regular No MountHIOSSEN, INC.DZE2026-07-14
00842092184301PreatPreat CorporationNHA2025-12-22
00842092184370PreatPreat CorporationNHA2025-12-22
00842092184394PreatPreat CorporationNHA2025-07-24
08806388277483Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388286973Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388286980Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388286997Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287000Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287017Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287024Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287031Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287048Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287055Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287062Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287079Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287086Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287093Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
0880638828710908806388287109Megagen Implant Co. LtdNHA2023-06-08
08806388287116Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287123Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287130Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287147Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287154Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287161Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287178Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287185Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287192Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287208Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287215Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08