EK Implants and Abutments System

K203360 · Hiossen, Inc. · DZE · Jan 7, 2022 · Dental

Device Facts

Record IDK203360
Device NameEK Implants and Abutments System
ApplicantHiossen, Inc.
Product CodeDZE · Dental
Decision DateJan 7, 2022
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3640
Device ClassClass 2
AttributesTherapeutic

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 Story

EK Dental Implants and Abutments are endosseous dental implants surgically placed into jaw bone to support prosthetic restorations (crowns, bridges, overdentures). Implants feature internal hex connection, tapered body, and are manufactured from medical-grade titanium (Grade 4) or titanium alloy (Ti-6Al-4V). Surface treatments include SA (sandblasted/acid-etched) or NH (SA + D-glucose + NaCl). Abutments are available in various designs (healing, angled, freeform, goldcast, multi, rigid, stud, temporary, transfer) made from titanium alloy, Co-Cr-Mo alloy, or gold alloy. Used by dental clinicians in clinical settings. Implants are provided sterile (gamma radiation); abutments are provided non-sterile for user steam sterilization. Output is a stable foundation for prosthetic devices, restoring chewing function. Benefit is improved oral function for edentulous patients.

Clinical Evidence

No clinical data submitted. Substantial equivalence is supported by non-clinical bench testing, including mechanical fatigue testing (ISO 14801) on worst-case configurations (smallest diameter, greatest angulation) and established biocompatibility/sterilization validation based on predicate device data.

Technological Characteristics

Materials: Pure Titanium Grade 4 (ASTM F67), Titanium alloy Ti-6Al-4V (ASTM F136), Co-Cr-Mo alloy, Gold alloy. Design: Internal hex-connected, submerged, tapered body. Surface: SA (sandblasted/acid-etched) or NH (SA + D-glucose + NaCl). Sterilization: Gamma radiation (implants), steam sterilization (abutments). Connectivity: Mechanical interface for prosthetic support.

Indications for Use

Indicated for partially or fully edentulous patients (mandible/maxilla) requiring single or multiple-unit restorations (cemented, screw, or overdenture) or fixed bridgework support. Ultra-wide implants are for molar region only. Ø3.5mm implants are for lateral and central incisors. Delayed loading only.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Hiossen, Inc. Peter Lee QA/RA Manager 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030 Re: K203360 Trade/Device Name: EK Dental Implants and Abutments Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: December 6, 2021 Received: December 7, 2021 Dear Peter Lee: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K203360 Device Name EK Implants and Abutments System Indications for Use (Describe) 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. Type of use (Select one or both, as applicable) 区 Prescription Use (Part 21 CFR 801 Subpart D) [ Over-The-Counter Use (21 CFR 807 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (7/17) {3}------------------------------------------------ Image /page/3/Picture/0 description: The image is a logo for Hiossen Implant. The logo has the letters "HI" in red and the word "OSSEN" in gray. The word "IMPLANT" is in gray and is located below the word "OSSEN". 5 Ben Fairless Drive www.hiossen.com # 510(k) Summary | 6.1 Submitter Information:<br>Submitted by: | Hiossen, Inc.<br>85 Ben Fairless Drive<br>Fairless Hills, PA 19030 | |--------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------| | Contact Person:<br>Telephone Number:<br>Fax Number: | Peter Lee<br>267-759-7031<br>267-759-7031 | | Date Prepared: | December 27, 2021 | | 6.2 Device Name:<br>• Proprietary Name:<br>• Classification Name:<br>• CFR Number:<br>• Device Class:<br>• Product Code:<br>• Subsequent Product Code: | EK Implants and Abutments System<br>Endosseous dental implant<br>872.3640<br>Class II<br>DZE<br>NHA | # 6.3 Predicate Devices: | Primary | 510(k) | Manufacturer(s) | |------------------------|---------|-----------------| | Hiossen Implant System | K140934 | Hiossen, Inc. | K203360 | Reference | 510(k) | Manufacturer | |----------------------------------|---------|--------------------------| | ETIII Bio-SA Fixture System | K151626 | Hiossen, Inc. | | ETIII SA Fixture D3.2 | K153332 | Hiossen, Inc. | | Osstem Abutment System | K182091 | Osstem Implant Co., Ltd. | | Osstem Implant System - Abutment | K161689 | Osstem Implant Co., Ltd. | | Hiossen Prosthetic System | K140507 | Osstem Implant Co., Ltd. | | Prosthetic System | K110308 | Osstem Implant Co., Ltd. | # 6.4 Description of Device: 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. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image is a logo for Hiossen Implant. The logo features the word "Hiossen" in a stylized font, with the "H" in red and the rest of the letters in gray. The word "Implant" is written in smaller gray letters below "Hiossen". The logo is simple and modern, and it is likely used to promote the company's dental implant products. | EK DENTAL IMPLANTS | Diameter (mm) | Length (mm) | |--------------------|---------------|----------------------------| | EKIII SA Implants | 3.5 | 8.5, 10.0, 11.5, 13.0 | | EKIII SA Implants | 4.0 ~ 5.5 | 7.0, 8.5, 10.0, 11.5, 13.0 | | EKIII NH Implants | 3.5 | 8.5, 10.0, 11.5, 13.0 | | EKIII NH Implants | 4.0 ~ 5.5 | 7.0, 8.5, 10.0, 11.5, 13.0 | | EK DENTAL ABUTMENTS | Diameter (mm) | Length (mm) | |---------------------|---------------|---------------| | EK Healing | 4.0 ~ 8.0 | 3.0 ~ 7.0 | | EK Angled | 4.0 ~ 6.0 | 13.0, 15.0 | | EK Freeform ST | 4.0 ~ 7.0 | 14.0, 15.0 | | EK Goldcast | 4.0, 4.5 | 13.0 ~ 16.0 | | EK Multi | 4.8 | 9.0 ~ 13.0 | | EK Multi Angled | 4.8 | 6.0, 7.0, 8.0 | | EK NP Cast | 4.0, 4.5 | 13.0 ~ 16.0 | | EK Rigid | 4.0 ~ 7.0 | 4.0, 5.5, 7.0 | | EK Stud | 3.5 | 9.0 ~ 15.0 | | EK Temporary | 4.0, 4.5 | 13.0 ~ 16.0 | | EK Transfer | 4.0 ~ 7.0 | 8.0 ~ 15.0 | The EK Dental Implants and Abutments are similar to other commercially available products based on the intended use, the technology used, the material composition employed and performance characteristics. # 6.5 Indication for Use: The EK Dental Implants are indicated for use in partially or fully edentulous mandibles 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 6AI 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. # 6.6 Substantial Equivalence: # 6.6.1 EK Dental Implants The information and date provided in this submission established the EK Dental Implants are substantially equivalent to the primary predicate device, Hiossen Implant System (K140934). | Device | Proposed Devices<br>EKIII SA Dental Implants | Primary Predicate<br>Devices<br>Hiossen Implant System | Reference Devices<br>ETIII SA Fixture D3.2 | |---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Hiossen, Inc. | Hiossen, Inc. | Hiossen, Inc. | | 510(K) No. | K203360 | K140934 | K153332 | | Design | | | | | Intended use | The EK Dental Implants<br>are indicated for use in<br>partially or fully edentulous<br>mandibles and maxillae, in<br>support of single or<br>multiple-unit restorations<br>including; cemented,<br>screw or overdenture<br>restorations, and final or<br>temporary abutment<br>support for fixed<br>bridgework. It is indicated<br>for delayed loading. Ultra<br> | The HIOSSEN Implant<br>System is indicated for use<br>in partially or fully<br>edentulous mandibles and<br>maxillae, in support of<br>single or multiple unit<br>restorations including;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and final or<br>temporary abutment<br>support for fixed<br>bridgework. It is intended<br>for delayed loading. ETIII<br>SA Ultra-Wide Fixture is<br>intended to be used in the<br>molar region. | The ETIII SA Fixture<br>System (Ø3.2mm) is made<br>of titanium alloy (Ti 6Al 4V)<br>for Fixtures and Simple<br>Mount and pure titanium<br>for Cover Screw. The ETIII<br>SA Fixture System<br>(Ø3.2mm) is indicated for<br>use in mandibular and<br>maxillary lateral and<br>central incisor, in support<br>of single or multiple-unit<br>restorations including;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and final or<br>temporary abutment<br>support for fixed<br>bridgework. It is intended<br>for delayed loading. | | | Image: EK Dental Implant | Image: HIOSSEN Implant | Image: ETIII SA Fixture | | Structure | • Internal Hex-connected<br>• Submerged Fixture<br>• Tapered body shape | • Internal Hex-connected<br>• Submerged Fixture<br>• Tapered body shape &<br>Straight body shape | • Internal Hex-connected<br>• Submerged Fixture<br>• Straight body shape | | Diameters | 3.5 ~5.5 | 3.5 ~ 7.0 | 3.2 | | Lengths | 7.0 ~ 13.0 | 6.0 ~ 18.0 | 8.0 ~ 15.0 | | Material | • Pure Titanium Grade 4<br>(ASTM F67)<br>• Titanium alloy Ti-6Al-4V<br>(ASTM F136)* | • Pure Titanium Grade 4<br>(ASTM F67) | • Titanium alloy Ti-6Al-4V<br>(ASTM F136)* | | Surface | • SA (Sandblasted and<br>Acid etched) | • SA (Sandblasted and<br>Acid etched) | • SA (Sandblasted and<br>Acid etched) | | Sterilization | Gamma Radiation | Gamma Radiation | Gamma Radiation | | Packaging | • Secured in plastic<br>ampule<br>• Housed in Tyvek-lidded<br>blister tray<br>• Placed in a tamper-<br>evident outer package. | • Secured in plastic<br>ampule<br>• Housed in Tyvek-lidded<br>blister tray<br>• Placed in a tamper-<br>evident outer package. | • Secured in plastic<br>ampule<br>• Housed in Tyvek-lidded<br>blister tray<br>• Placed in a tamper-<br>evident outer package. | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image is a logo for Hiossen Implant. The logo features the word "Hiossen" in a stylized font, with the "H" in red and the rest of the word in gray. There is a red swoosh above the "H". Below the word "Hiossen" is the word "Implant" in smaller, gray letters. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Hiossen Implant. The word "Hiossen" is displayed in a stylized font, with "Hi" in red and "ossen" in gray. Below the word "Hiossen" is the word "Implant" in gray, with each letter separated by a space. The logo is simple and modern, and the use of color helps to draw the eye. *3.5 diameter implant only | | Proposed Device | Primary Predicate<br>Devices | Reference Devices | |--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device | | | | | | EKIII NH Dental Implants | EIII Bio-SA Fixture<br>System | ETIII SA Fixture D3.2 | | Manufacturer | Hiossen, Inc. | Hiossen, Inc. | Hiossen, Inc. | | 510(K) No. | New device | K151626 | K153332 | | Design | Image: EKIII NH Dental Implants | Image: Elll Bio-SA Fixture System | Image: ETIII SA Fixture D3.2 | | Intended use | The EK Dental Implants<br>are indicated for use in<br>partially or fully edentulous<br>mandibles and maxillae, in<br>support of single or<br>multiple-unit restorations<br>including; cemented,<br>screw or overdenture<br>restorations, and final or<br>temporary abutment<br>support for fixed<br>bridgework. It is indicated<br>for delayed loading. Ultra<br>wide versions are<br>indicated for use in the<br>molar region only.<br>The EK Dental Implants<br>(Ø3.5mm) are made of | The ETIII Bio-SA Fixture<br>System is indicated for use<br>in partially or fully<br>edentulous mandibles and<br>maxillae, in support of<br>single or multiple-unit<br>restorations including;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and final or<br>temporary abutment<br>support for fixed<br>bridgework. It is intended<br>for delayed loading. Ultra<br>wide Fixture System is<br>intended to be used in the<br>molar region. | The ETIII SA Fixture<br>System (Ø3.2mm) is made<br>of titanium alloy (Ti 6Al 4V)<br>for Fixtures and Simple<br>Mount and pure titanium<br>for Cover Screw. The ETIII<br>SA Fixture System<br>(Ø3.2mm) is indicated for<br>use in mandibular and<br>maxillary lateral and<br>centeral incisor, in support<br>of single or multiple-unit<br>restorations including;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and final or<br>temporary abutment<br>support for fixed<br>bridgework. It is intended | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Hiossen Implant. The word "Hiossen" is written in a stylized font, with the "H" in red and the rest of the letters in gray. The word "Implant" is written in smaller gray letters below the word "Hiossen". The logo is simple and modern, and it is likely used to represent a company that manufactures or sells dental implants. | | for Fixtures and Simple<br>Mount and pure titanium<br>for Cover Screw. The EK<br>Dental Implants (Ø3.5mm)<br>are indicated for use in<br>mandibular and maxillary<br>lateral and central incisor,<br>in support of single or<br>multiple-unit restorations<br>including; cemented<br>retained, screw retained,<br>or overdenture<br>restorations, and final or<br>temporary abutment<br>support for fixed<br>bridgework. It is intended<br>for delayed loading.<br><br>The EK Dental Abutments<br>are indicated for use with<br>EK Dental Implants to<br>provide support to<br>prosthetic restoration such<br>as crowns, bridges and<br>overdentures in partially or<br>fully edentulous patients. | | | |---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------| | Structure | • Internal Hex-connected<br>• Submerged Fixture<br>• Tapered body shape | • Internal Hex-connected<br>• Submerged Fixture<br>• Tapered body shape | • Internal Hex-connected<br>• Submerged Fixture<br>• Straight body shape | | Diameters | 3.5 ~ 5.5 | 3.5 ~ 7.0 | 3.2 | | Lengths | 7.0 ~ 13.0 | 6.0 ~ 15.0 | 8.0 ~ 15.0 | | Material | • Pure Titanium Grade 4<br>(ASTM F67)<br>• Titanium alloy Ti-6Al-4V<br>(ASTM F136)* | • Pure Titanium Grade 4<br>(ASTM F67) | • Titanium alloy Ti-6Al-4V<br>(ASTM F136)* | | Surface | • NH (SA + D-glucose +<br>NaCl) | • NH (SA + D-glucose +<br>NaCl) | • NH (SA + D-glucose +<br>NaCl)** | | Sterilization | Gamma Radiation<br>• Secured in plastic<br>ampule | Gamma Radiation<br>• Secured in plastic<br>ampule | Gamma Radiation<br>• Secured in plastic<br>ampule | | Packaging | • Housed in Tyvek-lidded<br>blister tray<br>• Placed in a tamper-<br>evident outer package | • Housed in Tyvek-lidded<br>blister tray<br>• Placed in a tamper-<br>evident outer package | • Housed in Tyvek-lidded<br>blister tray<br>• Placed in a tamper-<br>evident outer package | * 3.5 diameter implant only ** NH version was adopted via internal documentation (letter to file). | Device | Proposed Device<br>EK Healing Abutment | Reference Devices<br>Hiossen Healing Abutment | |--------------|----------------------------------------|-----------------------------------------------| | Manufacturer | Hiossen, Inc. | Hiossen, Inc. | | 510(K) No. | New device | K140934 | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Hiossen Implant. The logo has the word "Hiossen" in a stylized font, with the "H" in red and the rest of the word in gray. The word "Implant" is written in smaller gray letters below the word "Hiossen". There is a registered trademark symbol next to the word "Hiossen". | Design | Image: Dental implant | Image: Dental implant | |---------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------| | Intended use | Used to make a natural soft tissue shape<br>before setting up prosthetics and<br>removing cover screw after<br>osseointegration. | Used to make a natural soft tissue shape<br>before setting up prosthetics and<br>removing cover screw after<br>osseointegration. | | Diameters | 4.0 ~ 8.0 | 4.0 ~ 8.0 | | Lengths | 3.0 ~ 7.0 | 3.0 ~ 7.0 | | Material | • Pure Titanium Grade 4 (ASTM F67) | • Pure Titanium Grade 4 (ASTM F67) | | Surface | • Machine surface | • Machine surface | | Sterilization | • Gamma Radiation | • Gamma Radiation | | Packaging | • Secured in plastic ampule<br>• Housed in Tyvek-lidded blister tray<br>• Placed in a tamper-evident outer<br>package | • Secured in plastic ampule<br>• Housed in Tyvek-lidded blister tray<br>• Placed in a tamper-evident outer<br>package | # 6.6.2 EK Dental Abutments The information and date provided in this submission established the EK Dental Implants are substantially equivalent to the reference devices listed below. | Device | Proposed Device<br>EK Dental Abutments | Reference Devices<br>Osstem Abutment System | |------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. | | 510(K) No. | New device | K182091 | | Intended use | The EK Dental Abutments are indicated<br>for use with EK Dental Implants to<br>provide support to prosthetic restoration<br>such as crowns, bridges and<br>overdentures in partially or fully<br>edentulous patients. | The Osstem Abutments System are<br>indicated for use with Hiossen Implants<br>to provide support to prosthetic<br>restoration such as crowns, bridges and<br>overdentures in partially or fully<br>edentulous patients. | | Surface | Machine surface | Machine surface | | Material | • Titanium alloy Ti-6AI-4V (ASTM F136) | • Titanium alloy Ti-6AI-4V (ASTM F136) | | Sterilization | • Delivered non-sterilized<br>• Steam sterilized by user | • Delivered non-sterilized<br>• Steam sterilized by user | | Packaging | • Housed in Tyvek-lidded blister tray<br>• Placed in a tamper-evident outer<br>package. | • Housed in Tyvek-lidded blister tray<br>• Placed in a tamper-evident outer<br>package. | | ANGLED<br>Design | Image: Angled Design | Image: Angled Design | | Diameters(mm) | 4.0 ~ 6.0 | 4.0 ~ 6.0 | | Heights(mm) | 8.0 | 8.0 | | Angulation | 17° | 17° | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Hiossen Implant. The logo has the word "Hiossen" in a stylized font, with the "H" and part of the curve above the "i" in red, and the rest of the word in gray. Below the word "Hiossen" is the word "IMPLANT" in a smaller, sans-serif font, also in gray. The logo is simple and modern, and the use of red and gray gives it a professional look. | MULTI<br>ANGLED<br>Design | Image: Multi Angled Design 1 | | Image: Multi Angled Design 2 | |---------------------------|------------------------------|---------------|------------------------------| | Diameters(mm) | 4.8 | 4.8 | | | G/H(mm) | 2.5 ~ 5.0 | 2.5 ~ 5.0 | | | Angulation | 17° | 17°, 30° | | | STUD Design | Image: STUD Design 1 | | Image: STUD Design 2 | | Diameters(mm) | 3.5 | 3.5 | | | G/H(mm) | 1.0 ~ 6.0 | 1.0 ~ 6.0 | | | TEMPORARY<br>Design | Image: TEMPORARY Design 1 | | Image: TEMPORARY Design 2 | | Diameters(mm) | 4.0, 4.5 | 4.0, 4.5 | | | Height(mm) | 10 | 10 | | | TRANSFER<br>Design | Image: TRANSFER Design 1 | | Image: TRANSFER Design 2 | | Diameters(mm) | 4.0 ~ 7.0 | 4.0 ~ 7.0 | | | Height(mm) | 4.0, 5.5, 7.0 | 4.0, 5.5, 7.0 | | | Device | Proposed Device<br>EK Dental Abutments | Reference Devices<br>Osstem Implant System - Abutment | |---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. | | 510(K) No. | New device | K161689 | | Intended use | The EK Dental Abutments are indicated<br>for use with EK Dental Implants to<br>provide support to prosthetic restoration<br>such as crowns, bridges and<br>overdentures in partially or fully<br>edentulous patients. | The Osstem Implant System - Abutments<br>are indicated for use with Hiossen<br>Implants to provide support to prosthetic<br>restoration such as crowns, bridges and<br>overdentures in partially or fully<br>edentulous patients. | | Surface | Machine surface | Machine surface | | Material | • Titanium alloy Ti-6AI-4V (ASTM F 136) | • Titanium alloy Ti-6AI-4V (ASTM F 136) | | Sterilization | • Delivered non-sterilized<br>• Steam sterilized by user | • Delivered non-sterilized<br>• Steam sterilized by user | | Packaging | • Secured in plastic ampule | • Secured in plastic ampule | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Hiossen Implant. The logo has the word "Hiossen" in a stylized font, with the "H" in red and the rest of the letters in gray. The word "Implant" is written in smaller gray letters below the word "Hiossen". There is a registered trademark symbol next to the word "Hiossen". | | • Housed in Tyvek-lidded blister tray<br>• Placed in a tamper-evident outer<br>package. | • Housed in Tyvek-lidded blister tray<br>• Placed in a tamper-evident outer<br>package. | |-----------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------| | FREEFORM<br>ST Design | Image: FREEFORM ST Design | Image: FREEFORM ST Design | | Diameters(mm) | 4.0 ~ 7.0 | 4.0 ~ 7.0 | | G/H(mm) | 1.5, 3.0 | 1.5, 3.0 | | MULTI Design | Image: MULTI Design | Image: MULTI Design | | Diameters(mm) | 4.8 | 4.8 | | G/H(mm) | 1.0 ~ 5.0 | 1.0 ~ 5.0 | | RIGID Design | Image: RIGID Design | Image: RIGID Design | | Diameters(mm) | 4.0 ~ 7.0 | 4.0 ~ 7.0 | | Height(mm) | 4.0, 5.5, 7.0 | 4.0, 5.5, 7.0 | | Device | Proposed Device<br>EK Dental Abutments | Reference Devices<br>Hiossen Prosthetic System | |-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. | | 510(K) No. | New device | K140507 | | Intended use | The EK Dental Abutments are indicated<br>for use with EK Dental Implants to<br>provide support to prosthetic restoration<br>such as crowns, bridges and<br>overdentures in partially or fully<br>edentulous patients. | The Hiossen Prosthetic System are<br>indicated for use with Hiossen Implants<br>to provide support to prosthetic<br>restoration such as crowns, bridges and<br>overdentures in partially or fully<br>edentulous patients. | | Material | • Co-Cr-Mo Alloy | • Co-Cr-Mo Alloy | | Sterilization | • Delivered non-sterilized<br>• Steam sterilized by user | • Delivered non-sterilized<br>• Steam sterilized by user | | Packaging | • Secured in plastic ampule<br>• Housed in Tyvek-lidded blister tray<br>• Placed in a tamper-evident outer<br>package. | • Secured in plastic ampule<br>• Housed in Tyvek-lidded blister tray<br>• Placed in a tamper-evident outer<br>package. | | NP CAST<br>Design | Image: EK Dental Abutments | Image: Hiossen Prosthetic System | {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for Hiossen Implant. The word "Hiossen" is written in a stylized font, with the "H" and the curved line above it in red, and the rest of the word in gray. Below the word "Hiossen" is the word "IMPLANT" in smaller, gray letters. The logo is simple and modern, and it is likely used to represent a company that specializes in dental implants. | Diameters(mm) | 4.0, 4.5 | 4.0, 4.5 | |-------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------| | Height(mm) | 10 | 10 | | Design parameters | • Height: minimum 4.0mmm above margin<br>• Wall thickness: 0.7mm and greater<br>• Angulation: maximum of 30 degrees | • Height: minimum 4.0mmm above margin<br>• Wall thickness: 0.7mm and greater<br>• Angulation: maximum of 30 degrees | | Device | Proposed Device<br>EK Dental Abutments | Reference Devices<br>Prosthetic System | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. | | 510(K) No. | New device | K110308 | | Intended use | The EK Dental Abutments are indicated<br>for use with EK Dental Implants to<br>provide support to prosthetic restoration<br>such as crowns, bridges and<br>overdentures in partially or fully<br>edentulous patients. | The Prosthetic System are indicated for<br>use with Hiossen Implants to provide<br>support to prosthetic restoration such as<br>crowns, bridges and overdentures in<br>partially or fully edentulous patients. | | Material…
Innolitics
510(k) Summary
Decision Summary
Classification Order
Enter a record ID and click Load to view the document.
100%