FDA.report

TRI

Primary DI
07640149880960
Brand
TRI
Company
TRI Dental Implants Int. AG
Model
B
Catalog number
TO70-07-F
Published
2019-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640149880960PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640149880960076401498809607640149880960

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

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

Primary DIBrandModelCatalogPublished
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
088000968507858plant Implant System8dent Inc.DZE2026-03-24
088000968507928plant Implant System8dent Inc.DZE2026-03-24
088000968507788plant Implant System8dent Inc.DZE2026-03-23
08800362100002DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100019DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100026DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100033DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100040DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100057DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100064DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100071DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100088DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100095DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100101DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100118DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100125DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100132DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100149DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100156DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100163DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100170DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100187DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100194DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100200DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100217DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100224DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100231DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100248DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100255DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100262DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20