FDA.reportPublic FDA data

SD BL Fixture

Primary DI
08800293192367
Brand
SD BL Fixture
Company
ARUM DENTISTRY Co., Ltd.
Model
B6007W
Published
2026-01-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

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
K250280000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250280000SD TL Implant SystemArum Dentistry Co., Ltd.2025-07-23DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800293192367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800293192367088002931923678800293192367

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
08800265648601Cemented AbutmentCAB4555M2026-03-11
08800265640377SD Bone Level FixtureB60102026-03-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810112921663(INOSS System) INOSS FixtureInosys, Inc.DZE2026-08-19
04099797000337CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000344CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000351CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000368CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000375CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000382CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000399CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000405CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000412CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000429CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000436CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000443CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000450CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000467CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000474CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000481CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000498CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000504CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000511CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000528CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000535CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000542CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000559CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000566CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000573CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000580CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000597CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000603CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000610CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17