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
07290109748344Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07290109748351Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07899878068266NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068273NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068280NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068297NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
D955BBCG35450Paul BandittTerlain Enterprises, Inc.NDP2026-09-25
07392532070303Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070310Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070327Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070334Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070341Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070358Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070365Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070372Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070389Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070396Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070402Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532037399Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-11-10
07392532000966Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000973Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000997Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001529Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001604Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001765Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001772Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001963Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001970Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001987Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001994Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14