FDA.reportPublic FDA data

TRI

Primary DI
07640149880816
Brand
TRI
Company
TRI Dental Implants Int. AG
Model
B
Catalog number
TO70-07-F
Published
2023-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
07640149880816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640149880816076401498808167640149880816

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
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
08800020806819SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020806826SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020806833SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020806871SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020806888SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020806895SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807113SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807120SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807137SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807144SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807274SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807281SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807298SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807304SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020840684SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020840691SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020840707SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020840714SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020840769SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020840776SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020841124SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020841131SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020841148SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020841155SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020841162SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020841179SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
00842448118561TITAN IMPLANTS INC.TITAN IMPLANT INCNHA2026-09-06
00810125998713ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998720ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998737ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04