Implantium, Superline

Primary DI
08809162701976
Brand
Implantium, Superline
Company
Dentium Co., Ltd.
Model
HAB402020L
Catalog number
HAB402020L
Device description
Endosseous dental implant abutment
Published
2016-10-12
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
08809162701976PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809162701976088091627019768809162701976

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
Length8.7Millimeter
Outer Diameter4Millimeter

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
689514395
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
08809544909761Implantium, SuperlineWFFD3606WFFD36062026-05-15
08809544909778Implantium, SuperlineWFFD3608WFFD36082026-05-15
08809544909785Implantium, SuperlineWFFD3610WFFD36102026-05-15
08809544909792Implantium, SuperlineWFFD3612WFFD36122026-05-15
08809544909808Implantium, SuperlineWFFD4006WFFD40062026-05-15
08809544909815Implantium, SuperlineWFFD4008WFFD40082026-05-15
08809544909822Implantium, SuperlineWFFD4010WFFD40102026-05-15
08809544909839Implantium, SuperlineWFFD4012WFFD40122026-05-15
08809544909846Implantium, SuperlineWFFD4506WFFD45062026-05-15
08809544909853Implantium, SuperlineWFFD4508WFFD45082026-05-15
08809544909860Implantium, SuperlineWFFD4510WFFD45102026-05-15
08809544909877Implantium, SuperlineWFFD4512WFFD45122026-05-15
08809544909884Implantium, SuperlineWFFD5006WFFD50062026-05-15
08809544909891Implantium, SuperlineWFFD5008WFFD50082026-05-15
08809544909907Implantium, SuperlineWFFD5010WFFD50102026-05-15
08809544909914Implantium, SuperlineWFFD5012WFFD50122026-05-15
08809544909921Implantium, SuperlineWFTP35WFTP352026-05-15
08809544909938Implantium, SuperlineWFTP45WFTP452026-05-15
08809544909945Implantium, SuperlineWFFL35WFFL352026-05-15
08809544909952Implantium, SuperlineWFFL45WFFL452026-05-15

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