FDA.reportPublic FDA data

K3Pro Konus Dental Implants

Primary DI
EAGNSK01K3PROKB0
Brand
K3Pro Konus Dental Implants
Company
Argon Medical Productions & Vertriebs Gesellschaft mbH & Co. KG
Model
SK01_K3Pro.KB
Catalog number
SK01_K3Pro.KB
Device description
K3Pro Basic Tray Rapid
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#

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
EAGNSK01K3PROKB0PrimaryHIBCC0

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