FDA.reportPublic FDA data

ST Internal Fixture

Primary DI
08809985651243
Brand
ST Internal Fixture
Company
Megagen Implant Co. Ltd
Model
ST4508D
Catalog number
ST4508DC
Device description
ST Internal Implant System
Published
2024-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
K192347000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192347000ST Internal Implant SystemMegagen Implant Co., Ltd.2019-11-14DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809985651243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809985651243088099856512438809985651243

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
687388178
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806388243402Multi-unit Angled AbutmentMUAAOH1725TMUAAOH1725TC2021-11-18
08806388243419Multi-unit Angled AbutmentMUAAOH1735TMUAAOH1735TC2021-11-18
08806388243426Multi-unit Angled AbutmentMUAAOH3035TMUAAOH3035TC2021-11-18
08806388243433Multi-unit Angled AbutmentMUAAOH3045TMUAAOH3045TC2021-11-18
08806388243440Multi-unit Angled AbutmentMUAAON1725TMUAAON1725TC2021-11-18
08806388243457Multi-unit Angled AbutmentMUAAON1735TMUAAON1735TC2021-11-18
08806388243464Multi-unit Angled AbutmentMUAAON3035TMUAAON3035TC2021-11-18
08806388243471Multi-unit Angled AbutmentMUAAON3045TMUAAON3045TC2021-11-18
08806388243488Multi-unit Angled AbutmentMUAARH1725LMUAARH1725LC2021-11-18
08806388243495Multi-unit Angled AbutmentMUAARH1735LMUAARH1735LC2021-11-18
08806388243501Multi-unit Angled AbutmentMUAARH3035LMUAARH3035LC2021-11-18
08806388243518Multi-unit Angled AbutmentMUAARH3045LMUAARH3045LC2021-11-18
08806388243525Multi-unit Angled AbutmentMUAARN1725LMUAARN1725LC2021-11-18
08806388243532Multi-unit Angled AbutmentMUAARN1735LMUAARN1735LC2021-11-18
08806388243549Multi-unit Angled AbutmentMUAARN3035LMUAARN3035LC2021-11-18
08806388243556Multi-unit Angled AbutmentMUAARN3045LMUAARN3045LC2021-11-18
08806388247325Multi-unit Angled AbutmentMUAAON1745TMUAAON1745TC2021-11-18
08806388250455Multi-unit Angled AbutmentMUAARH1745LMUAARH1745LC2021-11-18
08806388255986Multi-unit Angled AbutmentMUAAOH1745TMUAAOH1745TC2021-11-18
08809708759935Multi-unit Angled AbutmentMUAARN1745LMUAARN1745LC2021-11-18

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