FDA.reportPublic FDA data

Implantium, Superline

Primary DI
08809162700894
Brand
Implantium, Superline
Company
Dentium Co., Ltd.
Model
AAB155520HL
Catalog number
AAB155520HL
Device description
Endosseous dental implant abutment
Published
2019-04-01
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
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041368000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041368000DENTIUM CO., LTD. IMPLANTIUMDentium Co., Ltd.2004-07-29DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809162700894PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809162700894088091627008948809162700894

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
Length13.51Millimeter
Outer Diameter5.5Millimeter

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800070228951ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228968ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228975ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228982ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228999ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229002ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229019ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229026ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229033ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229040ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229057ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229064ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229071ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229088ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229095ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229101ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229118ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070203156ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203231ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203248ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203255ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203262ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203279ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203286ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203309ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203316ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203323ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04