FDA.reportPublic FDA data

OKTAGON Dental Implant BL NC

Primary DI
E0HM220101
Brand
OKTAGON Dental Implant BL NC
Company
Hager & Meisinger Gesellschaft mit beschränkter Haftung
Model
22010
Catalog number
22010
Device description
Bone Level Implant Narrow Connect Ø3.3x10mm
Published
2021-07-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
K143539000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143539000Dental Implant OKTAGON Bone LevelHager& Meisinger GmbH2015-08-31DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E0HM220101PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
+492173398000info@dental-ratio.de

Regulatory Flags#

DUNS number
318034329
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E0HM210023R2040181n/aHM23R 018500 204 194 006 0182026-08-17
E0HM25251GM1040601n/aHM251GM 060500 104 274 191 0602026-08-17
E0HM25251SX1040601n/aHM251SX 060500 104 274 224 0602026-08-17
E0HM29001912040051n/aHM191 005HM191 0052026-08-17
E0HM29001912040141n/aHM191 014HM191 0142026-08-17
E0HM72C703LHP1n/aC703LHPC703LHP2025-01-15
E0HM74MOD021n/aMOD02MOD022026-03-18
E0HM21000212040141n/aHM21 0145002041070060142026-07-24
E0HM22000013160121n/aHM1 0125003160010010122026-07-24
E0HM22000013160161n/aHM1 0165003160010010162026-07-24
E0HM22000013160211n/aHM1 0215003160010010212026-07-24
E0HM25079FX1040401n/aHM79FX 0405001041941400402026-07-24
E0HM39MI2071Bone ManagementMI207MI2072026-07-24
E0HM39MI2081Bone ManagementMI208MI2082026-07-24
E0HM72C0039HP1n/aC0039HPC0039HP2026-07-24
E0HM72C0060HP1n/aC0060HPC0060HP2026-07-24
EDRS220011OKTAGON Dental Implant BL RC22001220012015-10-01
EDRS220021OKTAGON Dental Implant BL RC22002220022015-10-01
EDRS220031OKTAGON Dental Implant BL RC22003220032015-10-01
EDRS220041OKTAGON Dental Implant BL RC22004220042015-10-01

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