(240 days)
The ET Abutment System are indicated for use with ET Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients.
The ET Abutment System are indicated for use with ET 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 ET Abutments are available in various lengths and diameters; configurations are listed in the table below.
This document describes a 510(k) premarket notification for a medical device called the "ET Abutment System," which is an endosseous dental implant abutment. The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through de novo clinical trials.
Therefore, the submission does not contain information about specific "acceptance criteria" for an AI algorithm's performance, nor does it detail a study proving such a device meets these criteria in the typical sense of AI/ML performance evaluation. The "studies" referenced are non-clinical bench tests demonstrating the physical and material properties of the dental abutments are comparable to existing, legally marketed devices.
Based on the provided text, here's an analysis of the "acceptance criteria" and "proof" in the context of this 510(k) submission:
The acceptance criteria and proof fundamentally revolve around demonstrating substantial equivalence to predicate devices, not performance against a specific clinical metric for an AI algorithm.
Missing Information:
The document concerns a physical dental device (abutment system), not an AI/ML powered device. As such, the concept of "acceptance criteria" for AI performance, clinical study design for AI (sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, etc.) are not applicable to this submission. The FDA letter confirms the device type: "Endosseous Dental Implant Abutment."
However, to address the prompt's implied need for "acceptance criteria" and "studies" as they relate to this specific device (dental abutment), I will interpret the request within the context of a 510(k) submission for a non-AI medical device.
1. Table of Acceptance Criteria and Reported Device Performance (as interpreted for a Dental Abutment System)
In a 510(k) submission for a dental abutment, "acceptance criteria" are typically defined by demonstrating that the proposed device has the same technological characteristics and similar performance to legally marketed predicate devices, or that differences do not raise new questions of safety and effectiveness. The "reported device performance" comes from non-clinical bench testing.
| Acceptance Criterion (for Substantial Equivalence to Predicate) | Reported Device Performance (from Non-Clinical Testing) |
|---|---|
| Intended Use Equivalence: The device has the same intended use as the predicate. | The ET Abutment System is "indicated for use with ET Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients." This matches the intended use of the primary predicate and reference devices, e.g., "Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures." |
| Technological Characteristics Equivalence: The device has comparable design, dimensions, materials, surface, sterilization, and packaging as the predicate. | - Design: "The ET Abutment System has the same design...as the predicate." (Explicitly stated) - Dimensions (Diameter, Length, Height, G/H): Various tables (pages 4, 5, 8, 9, 10, 11, 12, 13) compare proposed device dimensions to predicate/reference devices, showing direct matches or ranges that encompass them. E.g., ET Angled: Diameters 4.0 ~ 6.0 mm (Proposed) vs. 4.0 ~ 6.0 mm (Predicate). Heights 8.0 mm (Proposed) vs. 8.0 mm (Predicate). - Material: Primarily "Titanium alloy Ti-6Al-4V (ASTM F136)" or "Titanium CP Grade 3," and other specified materials (Nylon, Acrylonitrile & Butadiene Polymer (NBR), PolyCarbonate Polymer, Polyoxymethylene (POM), Gold alloy) are identical to those of the predicate devices. (Explicitly stated and documented in tables). - Surface: "Machine surface" across the board, matching predicates. (Explicitly stated and documented in tables). - Sterilization: "Delivered non-sterilized, Steam sterilized by user," matching predicates. "Validation was done following ISO 17665-1 [2006]... not necessary to re-test validation." - Packaging: "Housed in Tyvek-lidded blister tray; Placed in a tamper-evident outer package," matching predicates. Some also "Secured in plastic ampule." |
| Performance Equivalence (Non-Clinical): Device performance is similar, and any differences do not raise new questions of safety or effectiveness. | - Biocompatibility: "Contract manufactured by the predicate device manufacturer using the same manufacturing process and same well known and well-established material as the predicate device; therefore, we reason it was not necessary to re-test biocompatibility." - Shelf Life: "Do not have a stated shelf life" and "use the same exact packaging materials, manufactured from medical grade titanium alloy which are non-mechanical, non-active materials therefore, degradation in performance characteristics is not likely." - Surface Treatment Characterization Testing: "Contractured by the predicate device manufacturer, with surfaces using the same manufacturing process, material and surface finishing as the predicate devices... No additional character testing was necessary." - Mechanical Properties (Fatigue Testing): "Fatique testing of the worst case scenario was conducted per Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments." Proposed devices "were fatigue tested in accordance with ISO 14801 Dentistry - Fatique Test for Endosseous Dental Implants." This implies the proposed device met the fatigue resistance established for the predicate under this standard. - MRI Compatibility: "K221684 has cleared the contract manufacturer's support for the MRI compatibility of the ET Abutment System." A non-clinical review evaluated components in the MRI environment using scientific rationale and published literature, addressing force and torque per FDA guidance. |
| No New or Increased Risk: The device does not introduce new or increased risks compared to the predicate. | "The propose devices do not pose any new or increased risk as compared to both the legally marketed predicate and reference devices." This is the ultimate conclusion sought by demonstrating equivalence in all the above categories. |
2. Sample Size Used for the Test Set and Data Provenance
Since this is a physical medical device submission and not an AI/ML algorithm:
- Sample Size for Test Set: Not applicable in the context of an AI test set. For physical device testing, the sample sizes would be determined by the relevant ISO standards (e.g., ISO 14801 for fatigue testing). These specific numbers are not detailed in the summary but are typically part of detailed test reports that support the conclusion of substantial equivalence.
- Data Provenance: The data comes from non-clinical testing (bench tests) performed to standard specifications (e.g., ISO 14801). The "ET Abutment System are contract manufactured by the predicate device manufacturer," implying the manufacturing process and potentially some historical performance data are shared or directly comparable.
- Country of Origin: Not specified for the non-clinical test data itself, but the applicant (Hiossen Inc.) is in Fairless Hills, Pennsylvania, USA. The predicate manufacturer (Osstem Implant Co., Ltd.) is generally based in South Korea, suggesting potential international collaboration or shared manufacturing data.
- Retrospective or Prospective: Not applicable in the context of patient data. The non-clinical tests would be conducted prospectively on newly manufactured devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
- This concept is not applicable as this is not an AI/ML diagnostic or image analysis device that requires expert labeling or interpretation for "ground truth." The "ground truth" here is the adherence to material specifications, dimensional tolerances, and performance under specific mechanical and biological test conditions as defined by international standards.
4. Adjudication Method for the Test Set
- This concept is not applicable as there is no "test set" in the sense of clinical cases requiring interpretation or adjudication by multiple readers/experts. Performance is based on mechanical, material, and sterilization testing against predefined standards.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- Not applicable. This type of study is for evaluating human performance with or without AI assistance, typically in image interpretation or diagnosis. This submission is for a physical dental implant component. The document explicitly states: "No clinical performance report(s) is being submitted."
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Not applicable. This pertains to AI algorithm performance.
7. Type of Ground Truth Used
- The "ground truth" for this device's acceptance is based on engineering standards, material specifications, and performance data from validated non-clinical bench tests. This includes:
- ASTM (American Society for Testing and Materials) standards for materials (e.g., ASTM F136 for titanium alloy).
- ISO (International Organization for Standardization) standards for testing medical devices (e.g., ISO 14801 for fatigue testing of dental implants, ISO 17665-1 for moist heat sterilization).
- FDA guidance documents (e.g., "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments," "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment").
- Direct comparison to the established characteristics and performance of the legally marketed predicate devices.
8. Sample Size for the Training Set
- Not applicable. This concept relates to AI/ML model development. There is no "training set" for a physical dental abutment. The device's design and manufacturing rely on established engineering principles and prior knowledge from the predicate device.
9. How the Ground Truth for the Training Set was Established
- Not applicable. Again, this refers to AI/ML model training. The "ground truth" for developing a physical device is derived from engineering design principles, material science, and the performance history of similar devices.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Hiossen Inc. Peter Lee QA/RA Manager 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030
Re: K222636
Trade/Device Name: ET Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: March 30, 2023 Received: April 3, 2023
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 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
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K222636
Device Name
ET Abutment System
Indications for Use (Describe)
The ET Abutments are indicated for use with ET 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 (6/20)
Page 1 of 1
PSC Publishing Service (301) 443-6740 EF
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Hiossen Implant. The logo has the letters "HI" in red, with a curved line above the letters. The word "OSSEN" is in gray, and the word "IMPLANT" is in a smaller font below the word "OSSEN". There is a registered trademark symbol to the right of the word "OSSEN".
85 Ben Fairless Drive s Hills, PA 19030 888-768-0001 www.hiossen.com
Section 6 510(k) Summary - 12 PAGES
| 6.1 Submitter Information:Submitted by: | Hiossen, Inc.85 Ben Fairless DriveFairless Hills, PA 19030 |
|---|---|
| Contact Person:Telephone Number:Fax Number: | Peter Lee267-759-7031267-759-7031 |
| Date Prepared: | April 28, 2023 |
| 6.2 Device Name:• Proprietary Name:• Classification Name: | ET Abutment SystemImplant, Endosseous, Root |
| • Proprietary Name: | ET Abutment System |
|---|---|
| • Classification Name: | Implant, Endosseous, Root-form |
| • CFR Number: | 872.3630 |
| • Device Class: | Class II |
| • Product Code: | NHA |
6.3 Predicate Devices:
| Primary | 510(k) | Manufacturer(s) |
|---|---|---|
| Osstem Abutment System | K182091 | Osstem Implant Co., Ltd. |
| Reference | 510(k) | Manufacturer(s) |
| Osstem Implant System - Abutment | K161689 | Osstem Implant Co., Ltd. |
| ET US SS Prosthetic System | K160670 | Osstem Implant Co., Ltd. |
| Hiossen Prosthetic System | K140507 | Osstem Implant Co., Ltd. |
| ET/SS Implant System | K120847 | Osstem Implant Co., Ltd. |
| Prosthetic System | K110308 | Osstem Implant Co., Ltd. |
| HS/HG Prosthetic System | K100245 | Osstem Implant Co., Ltd. |
| HU/HS/HG Prosthetic System | K081575 | Osstem Implant Co., Ltd. |
| US/SS/GS System | K073247 | Osstem Implant Co., Ltd. |
| US System | K062030 | Osstem Implant Co., Ltd. |
6.4 Description of Device:
The ET Abutment System are indicated for use with ET 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 ET Abutments are available in various lengths and diameters; configurations are listed in the table below.
| EK DENTAL ABUTMENTS | Diameter (mm) | Length (mm) |
|---|---|---|
| ET Angled | 4.0 ~ 6.0 | 13.0, 15.0 |
| ET Convertible Angled Cylinder | 4.0, 4.8, 6.0 | 7.5 |
| ET Goldcast | 4.0, 4.5 | 13.0 ~ 16.0 |
{4}------------------------------------------------
Image /page/4/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 promote the company's dental implant products.
5 Ben Fairless Drive A 19030 www.hiossen.com
| ET Multi Angled | 4.80 | 9.00 ~ 13.00 |
|---|---|---|
| ET Multi Combination Cylinder | 5.00 | 7.30 |
| ET O-ring | 3.50, 4.60 | 1.15, 1.50 |
| ET Retainer, Retainer Cap | 5.00 | 4.40 |
| ET Port | 3.70 | 7.00 ~ 13.00 |
| ET Male Cap | 5.50 | 2.25 |
| ET Males | 4.75 | 1.80 |
| ET Stud | 3.50 | 9.00 ~ 15.00 |
| ET Temporary | 4.00, 4.50 | 13.00 ~ 16.00 |
| ET Transfer | 4.00 ~ 7.00 | 8.00 ~ 15.00 |
| ET Freeform ST | 4.00 ~ 7.00 | 14.00, 15.00 |
| ET Rigid | 4.00 ~ 7.00 | 4.00, 5.50, 7.00 |
| ET Rigid Protect Cap | 4.00 ~ 7.00 | 4.00, 5.50, 7.00 |
| ET Esthetic Low Temporary Cylinder | 4.80, 5.30 | 12.00 |
| ET Multi | 4.80 | 9.00 ~ 13.00 |
| ET Esthetic Low Gold Cylinder | 4.80 | 12.00 |
| ET Convertible Combination Cylinder | 4.00, 4.80, 6.00 | 7.00 |
| ET Convertible Temporary Cylinder | 4.00, 4.80, 6.00 | 9.80 |
| ET Convertible | 4.00, 4.80, 6.00 | 6.00 ~ 11.00 |
| ET Convertible GoldCast Cylinder | 4.00, 4.80, 6.00 | 11.75, 12.15 |
| ET Convertible Plastic Cylinder | 4.00, 4.80, 6.00 | 12.00 |
| ET Convertible Protect Cap | 4.00, 4.80, 6.00 | 2.90, 3.50 |
| ET Esthetic Low Plastic Cylinder | 4.80 | 12.00 |
| ET Esthetic Low Healing Cap | 4.80 | 4.60 |
The ET Abutment System are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
6.5 Indication for Use:
The ET Abutment System are indicated for use with ET 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 ET Abutment System
The information and date provided in this submission established the ET Abutment System are substantially equivalent to the primary predicate devices listed below. Proposed devices are the same devices Osstem (FEI 3003394081) received clearance listed as predicate and reference devices.
{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" 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 promote the company's dental implant products.
| Device | Proposed DeviceET Abutment System | Primary Predicate DevicesOsstem Abutment System |
|---|---|---|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K182091 |
| Intended use | The ET Abutments are indicated for usewith ET Dental Implants to provide supportto prosthetic restoration such as crowns,bridges and overdentures in partially or fullyedentulous patients. | Osstem Abutment System is intended foruse with a dental implant to provide supportfor prosthetic restorations such as crowns,bridges, or overdentures.• Link Abutment for CEREC |
| The Link Abutment for CEREC is titaniumalloy abutments placed onto OSSTEMdental implants to provide support forcustomized prosthetic restorations. LinkAbutment for CEREC is indicated for screw-retained single tooth or cement-retainedsingle tooth and bridge restorations. Alldigitally designed copings and/or crowns foruse with the Link abutment for CEREC is tobe scanned using Sirona CEREC AC orCEREC AF or CEREC AI, designed usingSirona inLab software (Version 3.65) orSirona CEREC Software (Version 4.2) andmanufactured using a Sirona CEREC orinLab MC X or MC XL milling unit. CAD/CAMmanufacturing/milling occurs at dentallaboratories per the design limitations of theSirona CEREC. | ||
| Sterilization | • Delivered non-sterilized• Steam sterilized by user | • Delivered non-sterilized• Steam sterilized by user |
| Packaging | • Housed in Tyvek-lidded blister tray• Placed in a tamper-evident outerpackage. | • Housed in Tyvek-lidded blister tray• Placed in a tamper-evident outerpackage. |
| ET ANGLED | ||
| Design | ||
| Surface | Machine surface | Machine surface |
| Material | • Titanium alloy Ti-6Al-4V (ASTM F136) | • Titanium alloy Ti-6Al-4V (ASTM F136) |
| Diameters(mm) | 4.0 ~ 6.0 | 4.0 ~ 6.0 |
| Heights(mm) | 8.0 | 8.0 |
| Angulation | 17° | 17° |
| ET CONVERTIBLE ANGLED CYLINDER | ||
| Design | ||
| Surface | Machine surface | Machine surface |
| Material | • Titanium CP Grade 3 | • Titanium CP Grade 3 |
| Diameters(mm) | 4.0, 5.0 | 4.0, 5.0, 6.0 |
| Height(mm) | 8.0 | 8.0 |
| ET MULTI ANGLED | ||
| Design | Image: ET MULTI ANGLED | Image: ET MULTI ANGLED |
| Surface | Machine surface | Machine surface |
| Material | • Titanium alloy Ti-6Al-4V (ASTM F136) | • Titanium alloy Ti-6Al-4V (ASTM F136) |
| Diameters(mm) | 4.8 | 4.8 |
| G/H(mm) | $2.5 ~ 5.0$ | $2.5 ~ 5.0$ |
| Angulation | $17°, 30°$ | $17°, 30°$ |
| ET MULTI COMBO CYLINDER | ||
| Design | Image: ET MULTI COMBO CYLINDER | Image: ET MULTI COMBO CYLINDER |
| Surface | Machine surface | Machine surface |
| Material | • Titanium CP Grade 3 | • Titanium CP Grade 3 |
| Diameters(mm) | 5.0 | 5.0 |
| Height(mm) | 7.3 | 7.3 |
| ET PORT | ||
| Design | Image: ET PORT | Image: ET PORT |
| Surface | Machine surface | Machine surface |
| Material | • Titanium alloy Ti-6Al-4V (ASTM F136) | • Titanium alloy Ti-6Al-4V (ASTM F136) |
| Diameters(mm) | 3.7 | 3.7 |
| G/H(mm) | $1.0~5.0$ | $1.0~5.0$ |
| ET Male Cap | ||
| Design | Image: ET Male Cap | Image: ET Male Cap |
| Surface | Machine surface | Machine surface |
| Material | • Titanium alloy Ti-6Al-4V (ASTM F136) | • Titanium alloy Ti-6Al-4V (ASTM F136) |
| Diameters(mm) | 5.5 | 5.5 |
| Height(mm) | 2.25 | 2.25 |
| ET Port Males | ||
| Design | Image: ET Port Males | Image: ET Port Males |
| Material | • Nylon | • Nylon |
| Diameters(mm) | 4.73 | 4.73 |
| Height(mm) | 1.80 | 1.80 |
| ET Port Extended Males | ||
| Design | Image: ET Port Extended Males | Image: ET Port Extended Males |
| Material | • Nylon | • Nylon |
| Diameters(mm) | 4.75 | 4.75 |
| Height(mm) | 1.80 | 1.80 |
| ET STUD | ||
| Design | Image: ET STUD | Image: ET STUD |
| Surface | Machine surface | Machine surface |
| Material | • Titanium alloy Ti-6Al-4V (ASTM F136) | • Titanium alloy Ti-6Al-4V (ASTM F136) |
| Diameters(mm) | 3.5 | 3.5 |
| G/H(mm) | 1.0 ~ 6.0 | 1.0 ~ 6.0 |
| ET O-RING | ||
| Design | Image: ET O-RING Design | Image: ET O-RING Design |
| Material | • Acrylonitrile & Butadiene Polymer (NBR) | • Acrylonitrile & Butadiene Polymer (NBR) |
| Diameter | 3.50, 4.60 | 3.50, 4.60 |
| Height | 1.15, 1.50 | 1.15, 1.50 |
| ET RETAINER, CAP | ||
| Design | Image: ET RETAINER, CAP Design | Image: ET RETAINER, CAP Design |
| Surface | Machine surface | Machine surface |
| Material | • Titanium CP Grade 3 | • Titanium CP Grade 3 |
| Diameter | 5.00 | 5.00 |
| Height | 2.00, 3.90 | 2.00, 3.90 |
| ET TEMPORARY | ||
| Design | Image: ET TEMPORARY Design | Image: ET TEMPORARY Design |
| Surface | Machine surface | Machine surface |
| Material | • Titanium CP Grade 3 | • Titanium CP Grade 3 |
| Diameters(mm) | 4.0, 4.5 | 4.0, 4.5 |
| Height(mm) | 10 | 10 |
| ET TRANSFER | ||
| Design | Image: ET TRANSFER Design | Image: ET TRANSFER Design |
| Surface | Machine surface | Machine surface |
| Material | • Titanium alloy Ti-6Al-4V (ASTM F136) | • Titanium alloy Ti-6Al-4V (ASTM F136) |
| Diameters(mm) | 4.0 ~ 7.0 | 4.0 ~ 7.0 |
| Height(mm) | 4.0. 5.5. 7.0 | 4.0. 5.5. 7.0 |
{6}------------------------------------------------
Image /page/6/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". The logo is simple and modern.
{7}------------------------------------------------
Image /page/7/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. Below the word "Hiossen" is the word "IMPLANT" in a smaller, gray font. The logo is simple and modern, and it is likely used to represent a company that manufactures or sells dental implants.
| Device | Proposed DeviceET Abutment System | Reference DevicesOsstem Implant System - Abutment |
|---|---|---|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K161689 |
| Intended use | The ET Dental Abutments are indicated foruse with ET Dental Implants to providesupport to prosthetic restoration such ascrowns, bridges and overdentures inpartially or fully edentulous patients. | The OSSTEM Implant System - Abutmentis intended for use with a dental implant toprovide support for prosthetic restorationssuch as crowns, bridges, or overdentures. |
| Sterilization | • Delivered non-sterilized• Steam sterilized by user | • Delivered non-sterilized• Steam sterilized by user |
| Packaging | • Secured in plastic ampule• Housed in Tyvek-lidded blister tray• Placed in a tamper-evident outerpackage. | • Secured in plastic ampule• Housed in Tyvek-lidded blister tray• Placed in a tamper-evident outerpackage. |
| ET FREEFORM ST |
| ET FREEFORM ST
{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" and part of the "i" in red, and the rest of the word in gray. Below the word "Hiossen" is the word "Implant" in a smaller, gray font. 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
| Design | Image: Design | Image: Design |
|---|---|---|
| Surface | Machine surface | Machine surface |
| Material | • Titanium alloy Ti-6Al-4V (ASTM F 136) | • Titanium alloy Ti-6Al-4V (ASTM F 136) |
| Max. Angulation | 17° | 17° |
| Diameters(mm) | 4.0 ~ 7.0 | 4.0 ~ 7.0 |
| G/H(mm) | 1.5, 3.0 | 1.5, 3.0 |
| ET RIGID | ||
| Design | Image: Design | Image: Design |
| Surface | Machine surface | Machine surface |
| Material | • Titanium alloy Ti-6Al-4V (ASTM F 136) | • Titanium alloy Ti-6Al-4V (ASTM F 136) |
| Diameters(mm) | 4.0 ~ 7.0 | 4.0 ~ 7.0 |
| Height(mm) | 4.0, 5.5, 7.0 | 4.0, 5.5, 7.0 |
| ET RIGID PROTECT CAP | ||
| Design | Image: Design | Image: Design |
| Material | • PolyCarbonate Polymer | • PolyCarbonate Polymer |
| 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 DeviceET Abutment System | Reference DevicesET US SS Prosthetic System |
|---|---|---|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K160670 |
| Intended use | The ET Dental Abutments are indicated foruse with ET Dental Implants to providesupport to prosthetic restoration such ascrowns, bridges and overdenturesinpartially or fully edentulous patients. | ET SystemThe HIOSSEN Prosthetic system isintended for use with a dental implant toprovide support for prosthetic such ascrowns, bridges, or overdentures.US/SS SystemThe OSSTEM Prosthetic system is intendedfor use with a dental implant to providesupport for prosthetic such as crowns,bridges, or overdentures. |
| Sterilization | • Delivered non-sterilized• Steam sterilized by user | • Delivered non-sterilized• Steam sterilized by user |
| Packaging | • Secured in plastic ampule• Housed in Tyvek-lidded blister tray• Placed in a tamper-evident outerpackage. | • Secured in plastic ampule• Housed in Tyvek-lidded blister tray• Placed in a tamper-evident outerpackage. |
| ET ESTHETIC LOW TEMPORARY | ||
| Design | Image: ET ESTHETIC LOW TEMPORARY Design | Image: ET ESTHETIC LOW TEMPORARY Design |
| Surface | Machine surface | Machine surface |
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the Hiossen Implant logo. The word "Hiossen" is written in a stylized font, with the "H" in red and the rest of the letters 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 promote a dental implant company.
85 Ben Fairless Drive
Fairless Hills, PA 19030
888-768-0001
www.hiossen.com
| Material | • Titanium CP Grade 3 | • Titanium CP Grade 3 |
|---|---|---|
| Diameters(mm) | 5.3, 4.8 | 5.3, 4.8 |
| Height(mm) | 12.0 | 12.0 |
| ET MULTI | ||
| Design | Image: dental implant | Image: dental implant |
| Surface | Machine surface | Machine surface |
| Material | • Titanium alloy Ti-6Al-4V (ASTM F 136) | • Titanium alloy Ti-6Al-4V (ASTM F 136) |
| Diameters(mm) | 4.8 | 4.8 |
| G/H(mm) | 1.0 ~ 5.0 | 1.0 ~ 5.0 |
| Device | Proposed DeviceET Abutment System | Reference DevicesHiossen Prosthetic System |
|---|---|---|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K140507 |
| Intended use | The ET Dental Abutments are indicated foruse with ET Dental Implants to providesupport to prosthetic restoration such ascrowns, bridges and overdentures inpartially or fully edentulous patients. | The Hiossen Prosthetic System areindicated for use with a dental implant toprovide support to prosthetic restorationsuch as crowns, bridges and overdentures. |
| Material | • Gold alloy | • Gold alloy |
| Sterilization | • Delivered non-sterilized• Steam sterilized by user | • Delivered non-sterilized• Steam sterilized by user |
| Packaging | • Secured in plastic ampule• Housed in Tyvek-lidded blister tray• Placed in a tamper-evident outerpackage. | • Secured in plastic ampule• Housed in Tyvek-lidded blister tray• Placed in a tamper-evident outerpackage. |
| ET ESTHETIC LOW GOLD CYLINDER | ||
| Design | ||
| Image: ET ESTHETIC LOW GOLD CYLINDER | Image: ET ESTHETIC LOW GOLD CYLINDER | |
| Max. Angulation | 0° | 0° |
| Diameters(mm) | 4.8 | 4.8 |
| Height(mm) | 12.0 | 12.0 |
| Device | Proposed DeviceET Abutment System | Reference DevicesET/SS Implant System |
|---|---|---|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K120847 |
| Intended use | The ET Dental Abutments are indicated foruse with ET Dental Implants to providesupport to prosthetic restoration such ascrowns, bridges and overdenturesinpartially or fully edentulous patients. | The ET/SS Implant System is indicated foruse in partially or fully edentulous mandiblesand maxillae, in support of single or multiple-unit restorations including; cementedretained, screw retained, or overdenturerestorations, and final or temporaryabutment support for fixed bridgework. It isintended for delayed loading. The abutmentis intended for use with a dental implant |
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for Hiossen Implant. The logo features the letters "HI" in red, with a curved line extending from the top of the "H" over the "I". The rest of the word "OSSEN" is in gray, with a registered trademark symbol next to it. Below the word "OSSEN" is the word "IMPLANT" in smaller, gray letters.
| fixture to provide support for prostheticrestorations such as crowns, bridges, oroverdenture. | ||
|---|---|---|
| Surface | Machine surface | Machine surface |
| Material | • Titanium CP Grade 3 | • Titanium CP Grade 3 |
| Sterilization | • Delivered non-sterilized | • Delivered non-sterilized |
| • Steam sterilized by user | • Steam sterilized by user | |
| Packaging | • Secured in plastic ampule | • Secured in plastic ampule |
| • Housed in Tyvek-lidded blister tray | • Housed in Tyvek-lidded blister tray | |
| • Placed in a tamper-evident outerpackage. | • Placed in a tamper-evident outerpackage. | |
| ET CONVERTIBLE COMBO CYLINDER | ||
| Design | Image: [Design] | Image: [Design] |
| Diameters(mm) | 4.0, 5.0, 6.0 | 4.0, 5.0, 6.0 |
| Height(mm) | 7.0 | 7.0 |
| Device | Proposed DeviceET Abutment System | Reference DevicesET/SS Implant System |
|---|---|---|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K110308 |
| Intended use | The ET Dental Abutments are indicated foruse with ET Dental Implants to providesupport to prosthetic restoration such ascrowns, bridges and overdentures inpartially or fully edentulous patients. | Prosthetic System is intended for use with adental implant to provide support forprosthetic restorations such as crowns,bridges, or overdentures.. |
| Sterilization | • Delivered non-sterilized• Steam sterilized by user | • Delivered non-sterilized• Steam sterilized by user |
| Packaging | • Secured in plastic ampule | • Secured in plastic ampule |
| • Housed in Tyvek-lidded blister tray | • Housed in Tyvek-lidded blister tray | |
| • Placed in a tamper-evident outerpackage. | • Placed in a tamper-evident outerpackage. | |
| ET GOLDCAST | ||
| Design | ||
| Max. Angulation | 30° | 30° |
| Surface | Machine surface | Machine surface |
| Material | • Titanium alloy Ti-6Al-4V (ASTM F136)• POM | • Titanium alloy Ti-6Al-4V (ASTM F136)• POM |
| Diameters(mm) | 4.0, 4.5 | 4.0, 4.5 |
| Device | Proposed DeviceET Abutment System | Reference DevicesHS/HG Prosthetic System |
|---|---|---|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K100245 |
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the Hiossen Implant logo. 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". There is a registered trademark symbol next to the word "Hiossen".
| Intended use | The ET Dental Abutments are indicated foruse with ET Dental Implants to providesupport to prosthetic restoration such ascrowns, bridges and overdentures inpartially or fully edentulous patients. | HS/HG Prosthetic System is intended foruse with a dental implant to provide supportfor prosthetic restorations such as crowns,bridges, or overdentures. |
|---|---|---|
| Surface | Machine surface | Machine surface |
| Material | • Titanium CP Grade 3 | • Titanium CP Grade 3 |
| Sterilization | • Delivered non-sterilized• Steam sterilized by user | • Delivered non-sterilized• Steam sterilized by user |
| Packaging | • Secured in plastic ampule• Housed in Tyvek-lidded blister tray• Placed in a tamper-evident outerpackage. | • Secured in plastic ampule• Housed in Tyvek-lidded blister tray• Placed in a tamper-evident outerpackage. |
| ET CONVERTIBLE TEMPORARY CYLINDER | ||
| Design | ||
| Diameters(mm) | 4.0, 5.0, 6.0 | 4.0, 5.0, 6.0 |
| Height(mm) | 12.0 | 12.0 |
| Device | Proposed DeviceET Abutment System | Reference DevicesHU/HS/HG Prosthetic System |
|---|---|---|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K081575 |
| Intended use | The ET Dental Abutments are indicated foruse with ET Dental Implants to providesupport to prosthetic restoration such ascrowns, bridges and overdentures inpartially or fully edentulous patients. | HU/HS/HG Prosthetic System is intendedfor use with a dental implant to providesupport for prosthetic restorations such ascrowns, bridges, or overdentures. |
| Sterilization | • Delivered non-sterilized• Steam sterilized by user | • Delivered non-sterilized• Steam sterilized by user |
| Packaging | • Secured in plastic ampule• Housed in Tyvek-lidded blister tray• Placed in a tamper-evident outerpackage. | • Secured in plastic ampule• Housed in Tyvek-lidded blister tray• Placed in a tamper-evident outerpackage. |
| ET CONVERTIBLE | ||
| Design | Image: ET Convertible Design | Image: HU/HS/HG Prosthetic System Design |
| Surface | Machine surface | Machine surface |
| Material | • Titanium alloy Ti-6Al-4V (ASTM F 136) | • Titanium alloy Ti-6Al-4V (ASTM F 136) |
| Diameters(mm) | 4.0, 4.5 | 4.0, 4.5 |
| G/H(mm) | 1.0, 3.0 | 1.0, 3.0 |
| ET CONVERTIBLE GOLDCAST | ||
| Design | Image: ET Convertible Goldcast Design | Image: Unknown Design |
| Material | • Gold alloy | • Gold alloy |
| Max. Angulation | 0° | 0° |
{12}------------------------------------------------
Image /page/12/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 "Hiossen". There is a registered trademark symbol next to the word "Hiossen".
| Diameters(mm) | 4.0, 4.8, 6.0 | 4.0, 4.8, 6.0 |
|---|---|---|
| G/H(mm) | 11.75, 12.15 | 11.75, 12.15 |
| ET CONVERTIBLE PLASTIC | ||
| Design | Image: ET CONVERTIBLE PLASTIC Design | Image: ET CONVERTIBLE PLASTIC Design |
| Material | · Polyoxymethylene (POM) | · Polyoxymethylene (POM) |
| Max. Angulation | 0° | 0° |
| Diameters(mm) | 4.0, 5.0, 6.0 | 4.0, 5.0, 6.0 |
| G/H(mm) | 12.0 | 12.0 |
| ET CONVERTIBLE PROTECT CAP | ||
| Design | Image: ET CONVERTIBLE PROTECT CAP Design | Image: ET CONVERTIBLE PROTECT CAP Design |
| Surface | Machine surface | Machine surface |
| Material | · Titanium alloy Ti-6Al-4V (ASTM F 136) | · Titanium alloy Ti-6Al-4V (ASTM F 136) |
| Diameters(mm) | 4.0, 4.8, 6.0 | 4.0, 4.8, 6.0 |
| Height(mm) | 2.9, 3.5 | 2.9, 3.5 |
| Device | Proposed DeviceET Abutment System | Reference DevicesUS/SS/GS Prosthetic System |
|---|---|---|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K073247 |
| Intended use | The ET Dental Abutments are indicated foruse with ET Dental Implants to providesupport to prosthetic restoration such ascrowns, bridges and overdenturesinpartially or fully edentulous patients. | The US/SS/GS System is indicated for usein partially or fully edentulous mandibles andmaxillae, in support of single or multiple-unitrestorations including; cemented retained,screw retained, or overdenture restorations,and terminal or intermediate abutmentsupport for fixed bridgework. The US/SS/GSSystem is for single and two stage surgicalprocedures. It is not for immediate load.. |
| Material | • Polyoxymethylene (POM) | • Polyoxymethylene (POM) |
| Sterilization | • Delivered non-sterilized• Steam sterilized by user | • Delivered non-sterilized• Steam sterilized by user |
| Packaging | • Secured in plastic ampule• Housed in Tyvek-lidded blister tray• Placed in a tamper-evident outerpackage. | • Secured in plastic ampule• Housed in Tyvek-lidded blister tray• Placed in a tamper-evident outerpackage. |
| ET ESTHETIC LOW PLASTIC CYLINDER | ||
| Design | Image: ET ESTHETIC LOW PLASTIC CYLINDER | Image: ET ESTHETIC LOW PLASTIC CYLINDER |
| Max. Angulation | 0° | 0° |
| Diameters(mm) | 4.80 | 4.80 |
| G/H(mm) | 12.00 | 12.00 |
| Device | Proposed Device | Reference Devices |
|---|---|---|
| ET Abutment System | US System |
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the logo for Hiossen Implant. The logo has the letters "HI" in red, with the rest of the word "OSSEN" in gray. Below the word "OSSEN" is the word "IMPLANT" in gray. The logo is simple and modern.
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
|---|---|---|
| 510(K) No. | New device | K062030 |
| Intended use | The ET Dental Abutments are indicated foruse with ET Dental Implants to providesupport to prosthetic restoration such ascrowns, bridges and overdentures inpartially or fully edentulous patients. | US System and SSII mini are intended foruse in partially or fully edentulous mandiblesand maxillae, in support of single or multiple-unit restorations, and terminal orintermediate abutment support for fixedbridgework. US System is for two stagesurgical procedures. It is not for one stageor immediate load. SSII mini is for one andtwo stage surgical procedures. It is not forimmediate load. |
| Surface | Machine surface | Machine surface |
| Material | • Titanium CP Grade 3 | • Titanium CP Grade 3 |
| Sterilization | • Delivered non-sterilized• Steam sterilized by user | • Delivered non-sterilized• Steam sterilized by user |
| Packaging | • Secured in plastic ampule | • Secured in plastic ampule |
| • Housed in Tyvek-lidded blister tray | • Housed in Tyvek-lidded blister tray | |
| • Placed in a tamper-evident outerpackage. | • Placed in a tamper-evident outerpackage. | |
| ET ESTHETIC LOW HEALING | ||
| Design | Image: abutment | Image: abutment |
| Diameters(mm) | 4.80 | 4.80 |
| G/H(mm) | 4.60 | 4.60 |
| Device | Proposed DeviceET Abutment System | Reference DevicesUS System |
|---|---|---|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K182091 |
| DeviceDescription | Screw securing abutment to dental implant | Screw securing abutment to dental implant |
| Surface | • Machine surface | • Machine surface |
| Material | • Titanium alloy Ti-6Al-4V (ASTM F 136) | • Titanium alloy Ti-6Al-4V (ASTM F 136) |
| Sterilization | • Delivered non-sterilized• Steam sterilized by user | • Delivered non-sterilized• Steam sterilized by user |
| 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. |
| EBONY GOLD SCREW | ||
| Design |
6.7 Non-Clinical Performance Data
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence include data from the following tests:
Biocompatibility Testing
{14}------------------------------------------------
Image /page/14/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. Below the word "Hiossen" is the word "IMPLANT" in smaller, gray letters. The logo is simple and modern, and it is likely used to promote the company's dental implant products.
ww.hiossen.com
The ET Abutment System are contract manufactured by the predicate device manufacturer using the same manufacturing process and same well known and wellestablished material as the predicate device; therefore, we reason it was not necessary to re-test biocompatibility in order to support the biological safety of the ET Abutment System. The proposed devices are manufactured from standard raw material that are used in the primary predicate device and other currently marketed dental implant and abutment system. Therefore, no additional biocompatibility testing is required to establish substantial equivalence.
Sterilization Validation
The ET Abutment System (are contractured by the predicate device manufacturer using the same manufacturing process, material and utilizes the same packing materials) are sterilized like the predicate devices listed in this submission. Like the predicate devices the proposed can be moist heat sterilized and was validated following ISO 17665-1 [2006] Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices, therefore we reason it was not necessary to re-test validation in order to support sterilization validity of the ET Abutment System.
Shelf Life
The ET Abutment System like the predicate listed in this submission do not have a stated shelf life. The proposed devices are non-sterile and use the same exact packaging materials, manufactured from medical grade titanium alloy which are non-mechanical, non-active materials therefore, degradation in performance characteristics is not likely.
Surface Treatment Characterization Testing
The ET Abutment System are contractured by the predicate device manufacturer, with surfaces using the same manufacturing process, material and surface finishing as the predicate devices listed in this submission. No additional character testing was necessary to support the ET Abutment System.
Mechanical Properties
The ET Abutment System fatique testing of the worst case scenario was conducted per Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments. Proposed dental attachments are contract manufactured by the predicate device manufacturer using the same manufacturing process, material and same design, as the predicates listed in this submission which were fatigue tested in accordance with ISO 14801 Dentistry - Fatique Test for Endosseous Dental Implants.
MRI Compatibility
K221684 has cleared the contract manufacturer's support for the MRI compatibility of the ET Abutment System. This clearance indicates that a non-clinical worst-case MRI review was performed to evaluate the Subject device components in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling" Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
6.8 Clinical Performance Testing
No clinical performance report(s) is being submitted.
6.9 Conclusion
In accordance with the Federal Food Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, HIOSSEN, INC. concludes since the ET Abutment System has the same design, intended use, structure, diameters, lengths, material surface, sterilization and packaging as the predicate
{15}------------------------------------------------
Image /page/15/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. Below the word "Hiossen" is the word "IMPLANT" in smaller, gray letters. The logo is simple and modern, and it is likely used to promote the company's dental implant products.
85 Ben Fairless Drive Fairless Hills, PA 19030 888-768-0001 www.hiossen.com
submission are are substantially
listed in this devices equivalent. The propose devices do not pose any new or increased risk as compared to both the legally marketed predicate and reference devices.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)