FDA.report

TRI

Primary DI
07640149880915
Brand
TRI
Company
TRI Dental Implants Int. AG
Model
B
Catalog number
TORT
Published
2019-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DZEImplant, Endosseous, Root-Form
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640149880915PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640149880915076401498809157640149880915

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+80033133313info@tri-implants.swiss

Regulatory Flags

DUNS number
485821164
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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07640149887181TRIAM-MUA-P45-N2026-01-27
07640149887198TRIAM-MUA-P37-N2026-01-27
07640149888942TRIAM-MUA-0.5-P372026-01-27
07640149888959TRIAM-MUA-0.5-P452026-01-27
07640149885149TRIBGIM-BLM-ISO2025-08-26
07640149885156TRIBGIM-Narrow-ISO2025-08-26
07640149885163TRIBGIM-Octa-ISO2025-08-26
07640149885170TRIBGIM-TLM-ISO2025-08-26
07640149885187TRIBGIM-Vent-ISO2025-08-26
07640149887112TRIBM-PFD-P372025-08-26
07640149887129TRICM-PFD-P452025-08-26
07640149887167TRIAM-MA-P372025-08-26
07640149887174TRIAM-MA-P452025-08-26
07640149887136TRIC M-PA-P372025-05-07
07640149887143TRICM-PA-P452025-05-07
07640149883244TRIACS-3.32025-04-08
07640149883251TRIACS-3.72025-04-08
07640149883268TRIACS-4.12025-04-08
07640149883275TRIACS-4.72025-04-08
07640149887204TRIBXFM-33-08-P372025-02-04

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Primary DIBrandCompanyProduct codePublished
08800055791203NB Master KitARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055791210NB Regular Kit ARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792774Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792781Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792798Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792804Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792910Torque ExtensionARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792958Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792965Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792972Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792996Torque RatchetARUM DENTISTRY Co., Ltd.NDP2026-03-24
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08800076423688URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423695URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423701URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423718URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
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