FDA.reportPublic FDA data

SD Tissue Level Fixture

Primary DI
08809982756682
Brand
SD Tissue Level Fixture
Company
ARUM DENTISTRY Co., Ltd.
Model
T4013
Published
2026-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242753000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242753000SD TL Implant SystemArum Dentistry Co., Ltd.2025-01-06DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809982756682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809982756682088099827566828809982756682

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
557821945
Device count
1
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
08800055715605Pre-milled BlankCIHE0232026-03-12
08800055715612Pre-milled BlankCIHE0242026-03-12
08800055715629Pre-milled BlankCIHE0252026-03-12
08800055715636Pre-milled BlankCIHE0262026-03-12
08800055715865Pre-milled BlankCIHE0532026-03-12
08800055715872Pre-milled BlankCIHE0542026-03-12
08800055715889Pre-milled BlankCIHE0552026-03-12
08800055715896Pre-milled BlankCIHE0562026-03-12
08800055715902Pre-milled BlankCIHE0572026-03-12
08800055715919Pre-milled BlankCIHE0582026-03-12
08800055716282Pre-milled BlankCIHE0952026-03-12
08800055716299Pre-milled BlankCIHE0962026-03-12
08800055716305Pre-milled BlankCIHE0972026-03-12
08800055716312Pre-milled BlankCIHE0982026-03-12
08800055716329Pre-milled BlankCIHE0992026-03-12
08800055716336Pre-milled BlankCIHE1002026-03-12
08800055746128Pre-milled BlankCIHE2012026-03-12
08800055746135Pre-milled BlankCIHE2022026-03-12
08800055762067Pre-milled BlankCIHE023P2026-03-12
08800055762074Pre-milled BlankCIHE024P2026-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EMKA03117ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA10503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA20503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA40503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA02821ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03110ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03114ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03115ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA10502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA20502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA40502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA80ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA8509ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA851517ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA851530ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA8515TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAB80ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAB80TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS80PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS80TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
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
EMKAC83ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11