FDA.reportPublic FDA data

K3Pro Konus Dental Implants

Primary DI
EAGNMBA400010NH2PRO0
Brand
K3Pro Konus Dental Implants
Company
Argon Medical Productions & Vertriebs Gesellschaft mbH & Co. KG
Model
MB.A 400010.NH/2Pro
Catalog number
MB.A 400010.NH/2Pro
Device description
4.0 x 1.0mm Mult Base Connector w/ 2mm Post - non-hex
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

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
EAGNMBA400010NH2PRO0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
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
07899995243898FIXATION SCREW CM11.5° ANG. MOD BSin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243904FIXATION SCREW CM11.5° ANG. MOD ASin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243928PARAF. DE FIXACAO MT16° ANG. MOD BSin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243935PARAF. DE FIXACAO MT16° ANG. MOD ASin Sistema de Implante Nacional S/ANHA2026-07-22
08806388266173ZrGEN AbutmentMegagen Implant Co. LtdNHA2024-01-31
08806388244812ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244829ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244836ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244843ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244850ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244867ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244874ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244898ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244904ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244911ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244928ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244935ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244942ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244959ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244966ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256624ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256631ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256648ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256655ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260690ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260706ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260737ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260744ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260966ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260973ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22