FDA.reportPublic FDA data

Implantium, Superline

Primary DI
08809544906265
Brand
Implantium, Superline
Company
Dentium Co., Ltd.
Model
DAB40105NT
Catalog number
DAB40105NT
Device description
Endosseous dental implant abutment
Published
2018-05-14
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
K160828000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160828000Dentium Implantium & SuperLine ProstheticsDentium Co., Ltd.2016-09-15NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809544906265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809544906265088095449062658809544906265

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length14.7Millimeter
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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