FDA.reportPublic FDA data

SuperLine

Primary DI
D755FX4008SWC0
Brand
SuperLine
Company
DENTIUM USA
Model
FX4008SWC
Catalog number
FX4008SWC
Device description
Endosseous dental implant
Published
2015-10-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160965000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160965000SuperLineDentium Co., Ltd.2017-01-13DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D755FX4008SWC0PrimaryHIBCC0

GMDN Terms#

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

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Millimeter
Outer Diameter4Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Stored and transported in a dry condition in the original package at room temperature and kept away from sunlight.

Sterilization Methods#

Method table
Method

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
Manufacturing date on label
true
Expiration date on label
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
07630031742124Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742131Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742148Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742155Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742162Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742179Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742186Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742193Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742209Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742216Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742223Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742230Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742247Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742254Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742407Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742414Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742421Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742438Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742445Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742452Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742469Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742476Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742483Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742490Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742506Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742513Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742520Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742537Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742612Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742629Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06