FDA.reportPublic FDA data

TRI

Primary DI
07640149887105
Brand
TRI
Company
TRI Dental Implants Int. AG
Model
A
Catalog number
M-C&B
Device description
matrix® crown and bridge
Published
2024-01-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

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
07640149887105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640149887105076401498871057640149887105

GMDN Terms#

Term, Definition table
TermDefinition
Dental bridge, ceramicA custom-made, non-removable, artificial replacement for one or more missing teeth made entirely of ceramic/porcelain material and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
485821164
Device count
1
Lot or batch
true
Manufacturing 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
EDMC32603024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32603087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32613024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32613087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32623024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32623087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32633024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32633087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32643024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32643087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32653024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32653087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32663024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32663087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32673024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32673087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32683024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32683087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32693024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32693087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32703024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32703087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32713024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32713087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32713098180NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32723024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32723087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32723098180NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32733024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32733087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16