FDA.reportPublic FDA data

K3Pro Konus Dental Implants

Primary DI
EAGNSK01K3PROZB0
Brand
K3Pro Konus Dental Implants
Company
Argon Medical Productions & Vertriebs Gesellschaft mbH & Co. KG
Model
SK01_K3Pro.ZB
Catalog number
SK01_K3Pro.ZB
Device description
K3Pro Basic Tray Sure
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141159000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141159000KONUS DENTAL IMPLANT SYSTEMArgon Med. Productions Vertriebs Gesellschaft Mbh2015-03-11DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EAGNSK01K3PROZB0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant/prosthesis surgical procedure kitA collection of various dental instruments designed for the surgical placement of dental implants or prostheses. It does not contain pharmaceuticals. It typically contains various dental drills (drill bits), drill extensions, depth gauges, wrenches and torque wrench, screwdrivers, forceps, trays and osteotomes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+49672130960info@argon-dental.de
+17158981434purchasing@argondentalusa.com

Regulatory Flags#

DUNS number
312649568
Device count
1
Kit
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EAGNBPSXP3502030K3Pro Konus Dental ImplantsBPS.XP 35020/3BPS.XP 35020/32024-11-12
EAGNEATK40KSET0K3Pro Konus Dental ImplantsEA.TK40_K/SETEA.TK40_K/SET2024-07-31
EAGNEATK50KSET0K3Pro Konus Dental ImplantsEA.TK50_K/SETEA.TK50_K/SET2024-07-31
EAGNEATK50KSSET0K3Pro Konus Dental ImplantsEA.TK50_S/SETEA.TK50_S/SET2024-07-31
EAGNEAZTS140K3Pro Konus Dental ImplantsEAZ_TS1.4EAZ_TS1.42016-09-21
EAGNETSK3PRO20K3Pro Konus Dental ImplantsETS.K3Pro/2ETS.K3Pro/22016-09-16
EAGNETSK3PRO30K3Pro Konus Dental ImplantsETS.K3Pro/3ETS.K3Pro/32016-09-16
EAGNFLAAS160K3Pro Konus Dental ImplantsFLA_AS1.6FLA_AS1.62016-09-22
EAGNHSVBA160K3Pro Konus Dental ImplantsHSVBA_1.6HSVBA_1.62016-09-16
EAGNMBS4000102PRO0K3Pro Konus Dental ImplantsMB.S 400010/2ProMB.S 400010/2Pro2016-09-19
EAGNMBS4000103PRO0K3Pro Konus Dental ImplantsMB.S 400010/3ProMB.S 400010/3Pro2016-09-19
EAGNMBS4000202PRO0K3Pro Konus Dental ImplantsMB.S 400020/2ProMB.S 400020/2Pro2016-09-19
EAGNMBS4000203PRO0K3Pro Konus Dental ImplantsMB.S 400020/2ProMB.S 400020/2Pro2016-09-19
EAGNMBS4000302PRO0K3Pro Konus Dental ImplantsMB.S 400030/2ProMB.S 400030/2Pro2016-09-19
EAGNMBS4000303PRO0K3Pro Konus Dental ImplantsMB.S 400030/3ProMB.S 400030/3Pro2016-09-19
EAGNAA400005H2PRO0K3Pro Konus Dental ImplantsAA 400005.H/2ProAA 400005.H/2Pro2016-09-12
EAGNAA400015H2PRO0K3Pro Konus Dental ImplantsAA 400015.H/2ProAA 400015.H/2Pro2016-09-12
EAGNAA400030H2PRO0K3Pro Konus Dental ImplantsAA 400030.H/2ProAA 400030.H/2Pro2016-09-13
EAGNAA400045H2PRO0K3Pro Konus Dental ImplantsAA 400045.H/2ProAA 400045.H/2Pro2016-09-13
EAGNAA401005H2PRO0K3Pro Konus Dental ImplantsAA 401005.H/2ProAA 401005.H/2Pro2016-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800076470569HS Cap SmallTruabutment Korea Co.,LtdNDP2026-07-21
08800076475830T-L Digital AnalogTruabutment Korea Co.,LtdNDP2026-07-21
08800076476042T-Marker KitTruabutment Korea Co.,LtdNDP2026-07-21
08800076476059T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476066T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476073T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476080T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476097T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476103T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476110T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476127T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476134T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476141T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476172T-Marker ScrewTruabutment Korea Co.,LtdNDP2026-07-21
08800076476219TruBite ScopeTruabutment Korea Co.,LtdNDP2026-07-21
08800076476226TruBoltTruabutment Korea Co.,LtdNDP2026-07-21
08800076476233TruBoltTruabutment Korea Co.,LtdNDP2026-07-21
08435673515131DYNAMIC ABUTMENT SOLUTIONSTALLADIUM ESPAÑA SLNDP2026-07-20
07899995235299DRIVER HANDPIECE MINI ABUT. EXT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235305DRIVER HANDPIECE MINI ABUT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235312DRIVER HANDPIECE MINI ABUT. MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235329DRIVER RATCHET ABUT. HEX 2MM EXT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235343DRIVER RATCHET ABUT. HEX 2MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235367DRIVER RATCHET ABUT. HEX 2MM MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235374DRIVER RATCHET ABUT. HEX 2MM SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235381DRIVER RATCHET ABUT. HEX 2MM EXT. SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235503DRIVER RATCHET RETRIVER M1.6MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235510DRIVER RATCHET RETRIVER M1.8MM MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235527DRIVER RATCHET RETRIVER M1.8MM SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235534DRIVER RATCHET RETRIVER M1.6MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14