Who is the manufacturer of EK D3.3 and Ultra Wide Implants?

Hiossen, Inc. filed the 510(k) submission for EK D3.3 and Ultra Wide Implants (K240232).

What is the FDA product code for EK D3.3 and Ultra Wide Implants?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for EK D3.3 and Ultra Wide Implants?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like EK D3.3 and Ultra Wide Implants?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

EK D3.3 and Ultra Wide Implants

Q: What are the predicate devices for EK D3.3 and Ultra Wide Implants?

EK Dental Implants and Abutments System (K203360).

K240232 · Hiossen, Inc. · DZE · Sep 13, 2024 · Dental

Device Facts

Record ID	K240232
Device Name	EK D3.3 and Ultra Wide Implants
Applicant	Hiossen, Inc.
Product Code	DZE · Dental
Decision Date	Sep 13, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

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 Story

Endosseous dental implants placed in jaw bone to support prosthetic restorations (crowns, bridges, overdentures) and restore chewing function. Device consists of titanium alloy (Ti 6Al 4V) or pure titanium fixtures, cover screws, and simple mounts. Available in various diameters and lengths; features internal hex connection and tapered body. Two surface types: SA (sandblasted/acid-etched) and NH (SA plus low-crystalline HA and super-hydrophilic coating). Used in dental clinics by trained clinicians. Implants are surgically placed; prosthetic components attached later. Provides stable foundation for dental restorations, improving patient oral function and aesthetics. Non-mechanical, non-active device.

Clinical Evidence

No clinical data submitted. Substantial equivalence demonstrated via bench testing, including fatigue testing per ISO 14801, sterilization validation per ISO 11137, and shelf-life validation per ISO 11607-1. Biocompatibility and surface characterization relied on predicate data and established material standards (ASTM F67, ASTM F136).

Technological Characteristics

Materials: Pure Titanium Grade 4 (ASTM F67) and Ti-6Al-4V alloy (ASTM F136). Design: Internal hex-connected, submerged, tapered body. Surface: SA (sandblasted/acid-etched) or NH (SA + nano-calcium phosphate/D-glucose/NaCl). Sterilization: Gamma radiation. Shelf life: 5-8 years. Connectivity: None (mechanical device).

Indications for Use

Indicated for partially or fully edentulous mandibles and maxillae in patients requiring single or multiple-unit restorations (cemented, screw, or overdenture) or fixed bridgework support. Ultra wide versions restricted to molar region. Ø3.3mm/Ø3.5mm versions indicated for mandibular and maxillary 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

EK Dental Implants and Abutments System (K203360)

Reference Devices

Hiossen Implant System (K140934)
ETIII Bio-SA Fixture System (K151626)
ETIII SA Fixture D3.2 (K153332)

Related Devices

K183242 — ET IV SA Dental Implants · Hiossen, Inc. · May 21, 2019
K031055 — ITI DENTAL IMPLANT SYSTEM · Straumann USA · Jul 7, 2003
K072980 — NOBELPERFECT CONICAL CONNECTION HEXAGONAL IMPLANTS · Nobel Biocare AB · Dec 20, 2007
K180598 — UNIQA Dental Implants System · Uniqa Dental, Ltd. · Aug 8, 2018
K253493 — Dentis SQ-SL AXEL Fixture · Dentis Co., Ltd. · Mar 4, 2026

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration". September 12, 2024 Hiossen, Inc. Peter Lee QA/RA Manager 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030 Re: K240232 Trade/Device Name: EK D3.3 and Ultra Wide Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: January 26, 2024 Received: August 13, 2024 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 (the 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 available 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}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. {2}------------------------------------------------ For comprehensive regulatory information about mediation-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 -S 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 Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use Submission Number (if known) K240232 Device Name EK D3.3 and Ultra Wide Dental Implants 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 & 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. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image is a logo for Hiossen Implant. The word "Hiossen" is written in a combination of red and gray letters. The word "Implant" is written in gray letters below the word "Hiossen." 85 Ben Fairless Drive A 19030 888-768-0001 www.hiossen.com DZE # 510(k) Summary | Submitter Information: | K24023 | |-----------------------------------------------------|--------------------------------------------------------------------| | Submitted by: | Hiossen, Inc. 85 Ben Fairless Drive Fairless Hills, PA 19030 | | Contact Person: Telephone Number: Fax Number: | Peter Lee 267-759-7031 267-759-7031 | | Date Prepared: | September 12, 2024 | | Device Name: | | | • Proprietary Name: | EK D3.3 and Ultra Wide Dental Implants | | • Classification Name: | Endosseous dental implant | | • CFR Number: | 872.3640 | | • Device Class: | Class II | #### Predicate Devices: • Product Code: | Primary | 510(k) | Manufacturer(s) | |-----------------------------------------|---------|-----------------| | EK Dental Implants and Abutments System | K203360 | Hiossen, Inc. | | Reference | 510(k) | Manufacturer(s) | | Hiossen Implant System* | K140934 | Hiossen, Inc. | | ETIII Bio-SA Fixture System | K151626 | Hiossen, Inc. | | ETIII SA Fixture D3.2 | K153332 | Hiossen, Inc. | #### Description of Device: 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. | EK DENTAL IMPLANTS | Diameter (mm) | Length (mm) | |------------------------------|---------------|--------------------------------| | EKIII SA D3.3 Implants | 3.3 | 8.7, 10.2, 11.7, 13.2 | | EKIII SA Ultra Wide Implants | 5.92 | 11.2, 12.7 | | | 5.95 | 6.4, 9.7 | | | 6.0 | 7.2, 8.2 | | | 6.8 | 6.4, 7.2, 8.2, 9.7, 11.2, 12.7 | {5}------------------------------------------------ Image /page/5/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 gray 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. 85 Ben Fairless Drive Fairless Hills, PA 19030 888-768-0001 www.hiossen.com | EKIII NH D3.3 Implants | 3.3 | 8.7, 10.2, 11.7, 13.2 | |------------------------------|------|--------------------------------| | EKIII NH Ultra Wide Implants | 5.92 | 11.2, 12.7 | | | 5.95 | 6.4, 9.7 | | | 6.0 | 7.2, 8.2 | | | 6.8 | 6.4, 7.2, 8.2, 9.7, 11.2, 12.7 | The EK D3.3 and Ultra Wide Dental Implants are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. #### 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 & Ø3.3mm) 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, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. #### Substantial Equivalence: The EK D3.3 and Ultra Wide Dental Implants The information and data provided in this submission established the EK D3.3 and Ultra Wide Dental Implants are substantially equivalent to the primary predicate devices, EK Dental Implant (K203360). {6}------------------------------------------------ Image /page/6/Picture/0 description: The image is a logo for Hiossen Implant. The word "Hiossen" is written in a combination of red and gray letters. Below the word "Hiossen" is the word "Implant" written in gray letters. | Device | Proposed Devices EK SA D3.3 and Ultra Wide Dental Implants | Predicate Devices EKIII SA Dental Implants | Reference Devices Hiossen Implant System | Reference Devices ETIII SA Fixture D3.2 | Similarities/ Differences | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Hiossen, Inc. | Hiossen, Inc. | Hiossen, Inc. | Hiossen, Inc. | | | 510(K) No. | New device | K203360 | K140934 | K153332 | | | Design | Image: Proposed Devices EK SA D3.3 and Ultra Wide Dental Implants | Image: Predicate Devices EKIII SA Dental Implants | Image: Reference Devices Hiossen Implant System | Image: Reference Devices ETIII SA Fixture D3.2 | Similar Difference: Size addition. Does not pose any new or increased risk. | | 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 | 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 | The HIOSSEN Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, 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. ETIII SA Ultra- Wide Fixture is intended to be used in the molar region. | The ETIII SA Fixture System (Ø3.2mm) is made of titanium alloy (Ti 6Al 4V) for Fixtures and Simple Mount and pure titanium for Cover Screw. The ETIII SA Fixture System (Ø3.2mm) is 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. | Similar Difference: To specify that the restriction of the 3.3mm diameter implant bodies to the lateral incisors which is covered in the indications of the K153332 submission | | | 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, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. | 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. | | | | | Structure | • Internal Hex- connected • Submerged Fixture • Tapered body shape | • Internal Hex- connected • Submerged Fixture • Tapered body shape | • Internal Hex- connected • Submerged Fixture • Tapered body shape & Straight body shape | • Internal Hex- connected • Submerged Fixture • Straight body shape | Similar Difference: Size addition. Does not pose any new or increased risk. | | Diameters(mm) | 3.3, 5.92, 5.95, 6.0, 6.80 | 3.5 ~ 5.5 | 3.5 ~ 7.0 | 3.2 | Equivalent | | Lengths(mm) | 6.4, 7.2, 8.2, 8.7, 9.7, 10.2, 11.2, 11.7, 12.7, 13.2 | 7.0 ~ 13.0 | 6.0 ~ 18.0 | 8.0 ~ 15.0 | Equivalent | | Diameter x Length(mm) | 3.3 x 8.7, 10.2, 11.7, 13.2 5.92 x 11.2, 12.7 5.95 x 6.4, 9.7 6.0 x 7.2, 9.7 6.8 x 6.4, 7.2, 8.2, 9.7, 11.2, 12.7 | 3.5 x 8.0 ~ 13.0 4.0 ~ 5.5 x 7.0 ~ 13.0 | 3.5 x 8.0 ~ 18.0 4.0 ~ 4.5 x 7.0 ~ 18.0 5.0 x 6.0 ~ 18.0 7.0 ~ 6.0 x 6.0 ~ 13.0 | 3.2 x 8.0 ~ 15.0 | Similar Difference: Size addition. Does not pose any new or increased risk. | | Material | • Pure Titanium Grade 4 (ASTM F67) • Titanium alloy Ti-6Al- 4V (ASTM F136)* | • Pure Titanium Grade 4 (ASTM F67) • Titanium alloy Ti-6Al- 4V (ASTM F136) | • Pure Titanium Grade 4 (ASTM F67) | • Titanium alloy Ti-6Al- 4V (ASTM F136)* | Equivalent | | Surface | • SA (Sandblasted and Acid etched) | • SA (Sandblasted and Acid etched) | • SA (Sandblasted and Acid etched) | • SA (Sandblasted and Acid etched) | Equivalent | | Sterilization | Gamma Radiation | Gamma Radiation | Gamma Radiation | Gamma Radiation | Equivalent | | Packaging | • Secured in plastic ampule • Housed in Tyvek- lidded blister tray • Placed in a tamper- evident outer package. | • Secured in plastic ampule • Housed in Tyvek- lidded blister tray • Placed in a tamper- evident outer package. | • Secured in plastic ampule • Housed in Tyvek- lidded blister tray • Placed in a tamper- evident outer package. | • Secured in plastic ampule • Housed in Tyvek- lidded blister tray • Placed in a tamper- evident outer package. | Equivalent | | Shelf life | 8 years | 8 years | 8 years | 8 years | Equivalent | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image is a 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". The logo is simple and modern. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Hiossen Implant. The logo is composed of the letters "HI" in red, followed by "OSSEN" in gray. A registered trademark symbol is next to the word "OSSEN". Below the word "OSSEN" is the word "IMPLANT" in gray. *3.3 diameter implant only | Device | Proposed Device EK NH D3.3 and Ultra Wide Dental Implants | Proposed Device EKIII NH Dental Implants | Predicate Devices EIII Bio-SA Fixture System | Predicate Devices ETIII SA Fixture D3.2 | Similarities/ Differences | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Hiossen, Inc. | Hiossen, Inc. | Hiossen, Inc. | Hiossen, Inc. | | | 510(K) No. | New device | K203360 | K151626 | K153332 | | | Design | | | | | Similar Difference: Size addition. Does not pose any new or increased risk. | | | | | | | | | 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 | 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 | The ETIII Bio-SA Fixture System is indicated for use in partially or fully edentulous mandibles and maxillae, 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. Ultra wide Fixture System is intended to be used in the molar region. | The ETIII SA Fixture System (Ø3.2mm) is made of titanium alloy (Ti 6Al 4V) for Fixtures and Simple Mount and pure titanium for Cover Screw. The ETIII SA Fixture System (Ø3.2mm) is indicated for use in mandibular and maxillary lateral and centeral 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. | Similar Difference: To specify that the restriction of the 3.3mm diameter implant bodies to the lateral incisors which is covered in the indications of the K153332 submission | | | 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. | 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. | | | | | Structure | • Internal Hex- connected | • Internal Hex- connected | • Internal Hex- connected | • Internal Hex- connected | Similar | | | • Submerged Fixture…