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510(k) Data Aggregation
K Number
K241003Device Name
HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)
Manufacturer
Hiossen, Inc.
Date Cleared
2025-01-08
(271 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
Hiossen, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HIOSSEN Pre-milled Abutments are intended for use with HIOSSEN dental implants to provide support for prosthetic restorations such as crowns, bridges or overdentures. All digitally designed CAD/CAM customizations for the HIOSSSEN Pre-milled Abutments are intended to be sent to a HIOSSEN validated milling facility.
Device Description
HIOSSEN Pre-milled Abutments are intended to support prosthetic restorations such as crowns, bridges or overdentures and used only with the Hiossen implant fixtures. HIOSSEN Pre-milled Abutments are customized (Milled) as per the patient specific requirements in the Hiossen validated milling laboratory. The HIOSSEN Pre-milled Abutments are designed and manufactured by Hiossen, Inc.
The HIOSSEN Pre-milled Abutments are Ti-6Al-4V titanium alloy (ASTM F136) cylindrical "blanks" with HIOSSEN dental implant-specific interface (abutment to implant connection and screw channel) to be designed and milled at a HIOSSEN validated milling facility using CAD/CAM technology to fabricate a patient-specific abutment.
The blank cylindrical HIOSSEN Pre-milled Abutments are supplied to the Hiossen validated milling centre. Based on the design requirements provided by the dentist, the lab will design abutment using 510k cleared CAD software and blank cylinders will be milled using the CAM machine. This customized patient specific milled abutment will be sent back to the dentist for implantation into the patient after steam sterilization.
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K Number
K240232Device Name
EK D3.3 and Ultra Wide Implants
Manufacturer
Hiossen, Inc.
Date Cleared
2024-09-13
(228 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Hiossen, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EK Dental Implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented, screw or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is indicated for delayed loading. Ultra wide versions are indicated for use in the molar region only.
The EK Dental Implants (Ø3.5mm & Ø3.3mm) are made of titanium alloy (Ti 6Al 4V) for Fixtures and Simple Mount and pure titanium for Cover Screw. The EK Dental Implants (Ø3.5mm & Ø3.3mm) are indicated for use in mandibular and maxillary lateral and central incisor, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
Device Description
The EK D3.3 and Ultra Wide Dental Implants are intended to be surgically placed in the bone of the upper or lower jaw arches, providing support to prosthetic devices to restore normal chewing functions. There are two types: SA and NH, both are bone level implants with the exact same internal hex, tapered body, use the same components and prosthetic parts, are manufactured from the same medical grade titanium materials and sterilized via gamma radiation. They only difference is the surface; SA is sand blasted and acid etched and NH is sand blasted and acid etched plus treated with a layer of low crystalline HA and super hydrophilic coating.
The EK D3.3 and Ultra Wide Dental Implants are available in various lengths and diameters; configurations are listed in the table below.
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K Number
K233389Device Name
EK Digital Abutments
Manufacturer
Hiossen, Inc.
Date Cleared
2024-05-29
(240 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
Hiossen, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EK DIGITAL ABUTMENTS are intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Device Description
EK DIGITAL ABUTMENTS are digitally designed patient specific abutments manufactured from titanium Alloy (Ti-6AI-4V ELI) and titanium alloy + zirconia. The EK Hybrid abutments are a two-piece abutment consisting of a pre-manufactured titanium base (ASTM F136) and a CAD/CAM patient-matched mesostructure component (ISO 6872) and PANAVIA F 2.0 (K032455) cement is used to attach the two structures. They are intended only for use with HIOSSEN EK dental implants to provide support for customized prosthetic restorations. EK DIGITAL ABUTMENTS are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. Each EK DIGITAL ABUTMENT is individually prescribed by the clinician.
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K Number
K203360Device Name
EK Implants and Abutments System
Manufacturer
Hiossen, Inc.
Date Cleared
2022-01-07
(417 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Hiossen, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EK Dental Implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented, screw or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is indicated for delayed loading. Ultra wide versions are indicated for use in the molar region only.
The EK Dental Implants (Ø3.5mm) are made of titanium alloy (Ti 6Al 4V) for Fixtures and Simple Mount and pure titanium for Cover Screw. The EK Dental Implants (Ø3.5mm) are indicated for use in mandibular and maxillary lateral and central incisor, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
The EK Dental Abutments are indicated for use with EK Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients.
Device Description
The EK Dental Implants are intended to be surgically placed in the bone of the upper or lower jaw arches, providing support to prosthetic devices to restore normal chewing functions. There are two types: SA and NH, both are bone level implants with the exact same internal hex, tapered body, use the same EK Dental Abutments, are manufactured from the same medical grade titanium materials and sterilized via gamma radiation. They only difference is the surface; SA is sand blasted and acid etched and NH which is SA + Dglucose + NaCI.
The EK Dental Abutments are indicated for use with EK Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients. Manufactured from medical grade titanium alloy and delivered non-sterilized.
The EK Dental Implants and Abutments are available in various lengths and diameters; configurations are listed in the table below.
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K Number
K191751Device Name
EM Provisional
Manufacturer
Hiossen, Inc.
Date Cleared
2019-12-16
(168 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Hiossen, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EM Provisional is intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to serve as temporary support for provisional prosthetic device during the healing phase of a permanent endosseous dental implant(s).
Device Description
The EM Provisional is a dental implant made of titanium alloy (Ti-6Al-4V) and is supplied sterile. The surface is machined finished and is intended to be surgically placed in the bone of the upper or lower jaw arches.
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K Number
K191201Device Name
EM SA Implant System
Manufacturer
Hiossen, Inc.
Date Cleared
2019-11-15
(193 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Hiossen, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EM SA Implant System (DENTURE) is intended to be place in the bone of the upper or lower jaw arches providing support to dental prosthetic devices, specifically for denture stabilization to restore a patient's chewing function. It is intended for single use only.
The EM SA Implant (NARROW RIDGE) is intended to be use in the treatment of missing mandibular central and lateral incisors to support dental prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. It is intended for single use only. It is intended for delayed loading.
Device Description
The EM SA Implant System is a dental implant made of titanium alloy (Ti-6AI-4V) and is supplied sterile. The surface treatment of EM SA Implant System is SA (Sandblasted and Acid etched) and is intended to be surgically placed in the bone of the upper or lower jaw arches.
The EM SA Implant System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. It is substantially equivalent in design, function and intended use to the OSSTEM Implant Co., Ltd.'s MS SA Implant System (K122171).
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K Number
K183242Device Name
ET IV SA Dental Implants
Manufacturer
Hiossen, Inc.
Date Cleared
2019-05-21
(181 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Hiossen, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ET IV SA Dental Implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented, screw or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Ultra wide version is intended to be used in the molar region.
Device Description
The ET IV SA Dental Implants are dental implants made from medical grade pure titanium metal (ASTM F67) and is supplied sterile. It is intended to be surgically placed in the bone of the upper or lower jaw arches. The ET IV SA Dental Implant is available in various lengths from 7.0 to 15mm and diameters from 4.4 to 7.1mm. The surface is SA: Sand blasted and Acid etched.
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K Number
K180527Device Name
IS3
Manufacturer
Hiossen, Inc.
Date Cleared
2018-05-16
(77 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
Hiossen, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IS3 is indicated for use in measuring the stability of dental implants in the oral cavity and the maxillofacial region.
Device Description
IS3 measurement system consists of: IS3 Instrument Hand-held instrument, Multi Peg Driver Driver to attach the ISQ peg to the implant, IS3 Charger 100-240 VAC to 5VDC charger for the instrument batteries, Multi Peg Measurement pin to attach to the implant. Different pins are available to fit different implant types.
The IS3 instrument is a hand-held, battery-driven device for measuring the relative stability of a dental implant. A small pin "Multi peg" is attached to the dental implant by a screw-connection, with the Multi Peg Driver. The pin has a small magnet incorporated into its top. The instrument is held towards the Multi Peg, and sends short magnetic pulses that bring the pin into vibration. After a pulse has been sent, the instrument measures the vibration by sampling the signal from the alternating magnetic field that follows from the vibrating pin. The frequency of the signal is determined by the instrument and is presented as an "ISQvalue", 1 to 100, where a higher number means higher stability. The measurement takes about 1 second.
The instrument consists of a microcontroller and circuits to send the magnetic pulses, to receive the measurement signal, and to present the measurement value. A circuit for battery-charging is also included. Two 2-digit LED displays, one on each side of the instrument, show the measurement value and also communicate possible error codes and software id number at start-up. One operating key is used to turn the instrument on and off. The electronics are contained in a plastic body, which is sealed except for the back of the instrument which has a charging connector. The plastic body is made from PC/ABS plastic except for the tip, which is made from PEEK. No part of the instrument is intended to contact the patient; however, there can be unintentional contact with the tip of the instrument. The instrument is battery-driven and contains re-chargeable NiMh-batteries. The batteries can be charged during use, but it should not be attached while measuring due to the risk of power line interference making it impossible to measure. For safety, a charger complying with IEC 60601-1 is used.The charger connector is of a type that does not allow other chargers to be connected, thereby eliminating the risk of the wrong charger being used.
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