FDA.reportPublic FDA data

TRI

Primary DI
07640149886443
Brand
TRI
Company
TRI Dental Implants Int. AG
Model
A
Catalog number
TLM-37-08-P45
Published
2022-02-22
Public version status
Update
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
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
K203660000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203660000TRI-matrix Implant LineTri Dental Implants Int. AG2021-12-21DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640149886443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640149886443076401498864437640149886443

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted 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 is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
485821164
Device count
1
Lot or batch
true
Expiration date on label
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
08806388205226Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205226Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205233Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205233Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205240Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205240Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205257Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205257Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205264Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205264Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205271Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205271Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205288Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205288Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205295Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205295Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205301Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205301Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388213023AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213023AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18
08806388213047AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213047AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18
08806388213061AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213061AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18
08806388213085AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213085AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18
08806388213108AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213108AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18
08806388213122AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213122AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18