FDA.reportPublic FDA data

K3Pro Konus Dental Implants

Primary DI
EAGNVBA50000PKKPK0
Brand
K3Pro Konus Dental Implants
Company
Argon Medical Productions & Vertriebs Gesellschaft mbH & Co. KG
Model
VBA50000PKK.PK
Catalog number
VBA50000PKK.PK
Device description
RapidFix/ Bar Base Abut Cap - Peek
Published
2016-09-22
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
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
EAGNVBA50000PKKPK0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
312649568
Device count
1
Lot or batch
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
06009544030287N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
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06009544053255N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
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