FDA.reportPublic FDA data

Trinon Titanium Q-Implant

Primary DI
ETRI4Q10M0
Brand
Trinon Titanium Q-Implant
Company
TRINON TITANIUM GMBH
Model
4Q10M
Device description
Q-Implant d=4,5/ L=10 mm/ cut end/ sterile
Published
2017-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ETRI4Q10M0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, one-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 one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+49 721932700trinon@trinon.com

Regulatory Flags#

DUNS number
312818750
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ETRI39Q080Trinon Titanium Q-Implant39Q082017-01-16
ETRI39Q100Trinon Titanium Q-Implant39Q102017-01-16
ETRI39Q120Trinon Titanium Q-Implant39Q122017-01-16
ETRI39Q140Trinon Titanium Q-Implant39Q142017-01-16
ETRI39QS080Trinon Titanium Q-Implant39QS082017-01-16
ETRI39QS100Trinon Titanium Q-Implant39QS102017-01-16
ETRI39QS120Trinon Titanium Q-Implant39QS122017-01-16
ETRI39QS140Trinon Titanium Q-Implant39QS142017-01-16
ETRI3Q080Trinon Titanium Q-Implant3Q082017-01-16
ETRI3Q100Trinon Titanium Q-Implant3Q102017-01-16
ETRI3Q120Trinon Titanium Q-Implant3Q122017-01-16
ETRI3Q140Trinon Titanium Q-Implant3Q142017-01-16
ETRI3Q3080Trinon Titanium Q-Implant3Q3082017-01-16
ETRI3Q3100Trinon Titanium Q-Implant3Q3102017-01-16
ETRI3Q3120Trinon Titanium Q-Implant3Q3122017-01-16
ETRI3Q3140Trinon Titanium Q-Implant3Q3142017-01-16
ETRI3QS080Trinon Titanium Q-Implant3QS082017-01-16
ETRI3QS100Trinon Titanium Q-Implant3QS102017-01-16
ETRI3QS120Trinon Titanium Q-Implant3QS122017-01-16
ETRI3QS140Trinon Titanium Q-Implant3QS142017-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800070229309ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
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08800070229323ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229330ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
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08809822767922AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767946AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767953AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12