FDA.reportPublic FDA data

Ti -Temporary Abutment

Primary DI
D755RAB45TH0
Brand
Ti -Temporary Abutment
Company
DENTIUM USA
Model
RAB45TH
Catalog number
RAB45TH
Device description
Endosseous dental implant abutment
Published
2016-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

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
K052957000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052957000IMPLANTIUM PROSTHETICSDentium Co., Ltd.2006-07-27NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D755RAB45TH0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length13.7Millimeter
Outer Diameter4.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(714)226-0229cs@dentiumusa.com

Regulatory Flags#

DUNS number
079689366
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D755FX3408MLC0ImplantiumFX3408MLCFX3408MLC2015-10-29
D755FX3410MLC0ImplantiumFX3410MLCFX3410MLC2015-10-29
D755FX3412MLC0ImplantiumFX3412MLCFX3412MLC2015-10-29
D755FX3414MLC0ImplantiumFX3414MLCFX3414MLC2015-10-29
D755FX3808MLC0ImplantiumFX3808MLCFX3808MLC2015-10-29
D755FX3810MLC0ImplantiumFX3810MLCFX3810MLC2015-10-29
D755FX3812MLC0ImplantiumFX3812MLCFX3812MLC2015-10-29
D755FX3814MLC0ImplantiumFX3814MLCFX3814MLC2015-10-29
D755FX4308MLC0ImplantiumFX4308MLCFX4308MLC2015-10-29
D755FX4310MLC0ImplantiumFX4310MLCFX4310MLC2015-10-29
D755FX4312MLC0ImplantiumFX4312MLCFX4312MLC2015-10-29
D755FX4314MLC0ImplantiumFX4314MLCFX4314MLC2015-10-29
D755FX4808MLC0ImplantiumFX4808MLCFX4808MLC2015-10-29
D755FX4810MLC0ImplantiumFX4810MLCFX4810MLC2015-10-29
D755FX4812MLC0ImplantiumFX4812MLCFX4812MLC2015-10-29
D755FX4814MLC0ImplantiumFX4814MLCFX4814MLC2015-10-29
D755FX3608SWC0SuperLineFX3608SWCFX3608SWC2015-10-29
D755FX3610SWC0SuperLineFX3610SWCFX3610SWC2015-10-29
D755FX3612SWC0SuperLineFX3612SWCFX3612SWC2015-10-29
D755FX3614SWC0SuperLineFX3614SWCFX3614SWC2015-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435389830764MULTI-IM® HEALING CAP, TINY® & UNIVERSAL PLATFORM L:3 mmBIOTECHNOLOGY INSTITUTE SLNHA2026-05-27
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EMKA40503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
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EMKA03110ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
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EMKA03115ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA10502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA20502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA40502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA80ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
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EMKABS81PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS82PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS83PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC80ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC80TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC81ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC81TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC82ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC82TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11