FDA.reportPublic FDA data

(INOSS System) INOSS Fixture

Primary DI
00810112921663
Brand
(INOSS System) INOSS Fixture
Company
Inosys, Inc.
Model
IBF-3708S
Device description
It is single screw structure as tapered shape that is manufactured using unalloyed titanium grade 4 as the raw material and is treated using SAT (Sandblasted Acid-etched Treatment) surface treatment.
Published
2026-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
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
K260006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260006000INOSS SystemInosys, Inc.2026-06-17DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810112921663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810112921663008101129216638101129216630810112921663

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.

Regulatory Flags#

DUNS number
101803383
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810112921625Pick-Up Impression Coping(Non-Hex)PBIP M45SN2024-02-13
00810112921632Pick-Up Impression Coping(Non-Hex)PBIP M45LN2024-02-13
00810112921649Pick-Up Impression Coping(Non-Hex)PBIP R45SN2024-02-13
00810112921656Pick-Up Impression Coping(Non-Hex)PBIP R45LN2024-02-13
00810112921571Fixture Lab AnalogPBFAN M35H2022-06-17
00810112921588Fixture Lab AnalogPBFAN R37H2022-06-17
00810112921595Fixture Lab AnalogPBFAN R40H2022-06-17
00810112921120PRIMUS Implant SystemPBCA R4555N2022-06-15
00810112921137PRIMUS Implant SystemPBCA R4565N2022-06-15
00810112921144PRIMUS Implant SystemPBCA R4517N2022-06-15
00810112921151PRIMUS Implant SystemPBCA R4527N2022-06-15
00810112921168PRIMUS Implant SystemPBCA R4537N2022-06-15
00810112921175PRIMUS Implant SystemPBCA R4547N2022-06-15
00810112921182PRIMUS Implant SystemPBCA R5514N2022-06-15
00810112921199PRIMUS Implant SystemPBCA R5524N2022-06-15
00810112921205PRIMUS Implant SystemPBCA R5534N2022-06-15
00810112921212PRIMUS Implant SystemPBCA R5544N2022-06-15
00810112921229PRIMUS Implant SystemPBCA R5515N2022-06-15
00810112921236PRIMUS Implant SystemPBCA R5525N2022-06-15
00810112921243PRIMUS Implant SystemPBCA R5535N2022-06-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04099797000627CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17