(181 days)
No
The summary describes a physical dental implant and its materials, dimensions, and intended use, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is a dental implant intended to support restorations, not to treat or cure a disease or condition.
No
The device is a dental implant intended for surgical placement to support restorations, not for diagnosing medical conditions.
No
The device description clearly states it is a dental implant made from titanium metal, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The ET IV SA Dental Implant is a surgically implanted device made of titanium, designed to be placed directly into the bone of the jaw. It is a physical implant, not a device that analyzes biological samples.
- Intended Use: The intended use is to support dental restorations in the mouth, which is a direct treatment/replacement function, not a diagnostic function based on analyzing samples.
Therefore, the ET IV SA Dental Implant falls under the category of a surgical implant or dental device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ET IV SA Dental Implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented, screw or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Ultra wide version is intended to be used in the molar region.
Product codes
DZE
Device Description
The ET IV SA Dental Implants are dental implants made from medical grade pure titanium metal (ASTM F67) and is supplied sterile. It is intended to be surgically placed in the bone of the upper or lower jaw arches.
The ET IV SA Dental Implant is available in various lengths from 7.0 to 15mm and diameters from 4.4 to 7.1mm, configurations are listed in the table below. The surface is SA: Sand blasted and Acid etched.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or fully edentulous mandibles and maxillae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing:
- Biocompatibility Testing: Deemed not necessary to re-test as manufactured using the same manufacturing process and material as the predicate device (K140934).
- Sterilization Validation: Deemed not necessary to re-validate as manufactured using the same manufacturing process, material, and sterilize barrier system, and gamma irradiated under the same conditions and process as the predicate device (K140934).
- Fatigue Testing: Deemed not necessary to re-test as manufactured using the same manufacturing process, material, and structure as the predicate device (K140934). Fatigue test data of ø 3.5 Hiossen Implant System, K140934, conducted per ISO 14801:2007 (Dentistry - Implants - Dynamic Fatigue Test for Endosseous Dental Implants), is applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
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.(b)
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.
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.
May 21, 2019
Hiossen, Inc. Peter Lee QA/RA Manager 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030
Re: K183242
Trade/Device Name: ET IV SA Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: April 19, 2019 Received: April 22, 2019
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Malvina Eydelman, M.D. Director 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: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K183242 Device Name
ET IV SA Dental Implants
Indications for Use (Describe)
The ET IV SA Dental Implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented, screw or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Ultra wide version is intended to be used in the molar region.
Type of use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 807 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Service (301) 443-6740 EF
ET IV SA Dental Implants Special 510(k)
Confidential
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Image /page/3/Picture/0 description: The image contains 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. Below the word "Hiossen" is the word "Implant" in a smaller, gray font. Below the logo is the text "K183242" in a bold, black font.
PAGE 1
| (1) Submitter Information:
Submitted by: | Hiossen, Inc.
85 Ben Fairless Drive
Fairless Hills, PA 19030 |
|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Contact Person:
Telephone Number:
Fax Number:
Email: | Peter Lee
267-759-7031
267-759-7031
peter.l@hiossen.com |
| Date Prepared: | May 21, 2019 |
| (2) Device Name:
• Proprietary Name:
• Classification Name:
• CFR Number:
• Device Class:
• Product Code: | ET IV SA Dental Implants
Implant, Dental, Endosseous
872.3640
Class II
DZE |
(3) Predicate Device(s):
| Device | 510(k) | Manufacturer | |
|---|---|---|---|
| Primary Predicate | HIOSSEN Implant System | K140934 | HIOSSEN, INC. |
| Reference Device | Osstem Implant System | K161604 | Osstem Implant Co., Ltd. |
(4) Description of Device:
The ET IV SA Dental Implants are dental implants made from medical grade pure titanium metal (ASTM F67) and is supplied sterile. It is intended to be surgically placed in the bone of the upper or lower jaw arches.
The ET IV SA Dental Implant is available in various lengths from 7.0 to 15mm and diameters from 4.4 to 7.1mm, configurations are listed in the table below. The surface is SA: Sand blasted and Acid etched.
The ET IV SA Dental Implant is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
| Diameter (mm) | Length (mm) | |
|---|---|---|
| ET IV SA | 4.4 | 7.0, 8.5, 10.0, 11.5, 13.0, 15.0 |
| ET IV SA | 4.8 | 7.0, 8.5, 10.0, 11.5, 13.0, 15.0 |
| ET IV SA | 5.25 | 7.0, 8.5, 10.0, 11.5, 13.0, 15.0 |
| ET IV SA Ultra Wide | 6.2 | 7.0, 8.5, 10.0, 11.5, 13.0 |
| ET IV SA Ultra Wide | 7.1 | 7.0, 8.5, 10.0, 11.5, 13.0 |
(5) Indication For Use:
The ET IV SA Dental Implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented, screw or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Ultra wide version is intended to be used in the molar region.
4
Image /page/4/Picture/0 description: The image shows the 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. Below the word "Hiossen" is the word "Implant" in a smaller font. The number K183242 is located in the bottom right corner of the image.
PAGE 2
(6) Substantial Equivalence:
Hiossen, Inc. received premarket clearance for the primary predicate Hiossen implant System under premarket notification K140934. Hiossen. Inc modified the ETII SA Fixture and ETIII SA Ultra-wide Fixture of the Hiossen Implant System. This modified ET III SA Ultra-wide Fixture is herewith submitted as a new 510(k) under the name ET IV SA Dental Implants.
The revision to the ET III SA Fixture and ET III SA Ultra-wide Fixture relates to the tapered body and thread. Table 1 shows the similarities and difference between the proposed device, ET IV SA Dental Implant and the primary predicate Hiossen Implant System – ET III SA Fixture and ET III SA Ultra-wide Fixture cleared under K140934 and reference device, Osstem Implant System - TSIV SA Fixture and TSIV Ultra-wide SA Fixture cleared under K161604.
The differences in the Indications for Use statements between the subject device and the primary predicate device and reference device such as the identification of the trade name of the device, removal of the word "retained" from the Indications for Use Statement does not alter the intended use of the subject device. Additionally, the Indications for Use Statement of the refence device provides instruction on the clinical use of the ø3.25mm and smaller sized device. The subject device does not contain a device in this size range and is not applicable.
Throughout this submission we show that the modifications does not affect the intended use of the device, indication for use, surgery type, structure, material, surface, sterilization method, shelf life and the fundamental scientific technology of the device when compared to the primary predicate device Hiossen Implant System (K140934) and reference device, Osstem Implant System, K161604. Therefore, the proposed device, ET IV SA Dental Implant is substantially equivalent to the primary predicate, Hiossen Implant System, K140934 and reference Osstem Implant System, K161604.
| Table 1 Device Comparison | |||
|---|---|---|---|
| Device | Proposed Device | ||
| ET IV SA Dental Implant | Primary Predicate | ||
| Hiossen Implant System | |||
| *ET III SA Fixture and ET | |||
| III SA Ultra-wide Fixture | |||
| (K140934) | Reference Device | ||
| Osstem Implant System | |||
| *TSIV SA Fixture & TSIV | |||
| SA Ultra wide Fixture | |||
| (K161604) | |||
| Manufacturer | Hiossen, Inc. | Hiossen, Inc. | Osstem Co., Ltd. |
| Indication for | |||
| Use | The ET IV SA Dental | ||
| Implants are indicated for | |||
| use in partially or fully | |||
| edentulous mandibles and | |||
| maxillae, in support of | |||
| single or multiple-unit | |||
| restorations including; | |||
| cemented, screw or | |||
| overdenture restorations, | |||
| and final or temporary | |||
| abutment support for fixed | |||
| bridgework. It is intended | |||
| for delayed loading. Ultra | |||
| wide version is intended to | |||
| be used in the molar | |||
| region. | 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 Osstem 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. Ultra | |||
| wide Fixture System is | |||
| intended to be used in the | |||
| molar region. Products | |||
| with diameter of less than | |||
| 3.25mm should be used |
5
Image /page/5/Picture/0 description: The image shows the logo for Hiossen Implant. The logo is in red and gray. Below the logo is the number K183242.
| PAGE 3 | | | | exclusively for the lateral
incisor in the maxilla and a
central or lateral incisor in
the mandible. |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Surgery
Type | One or two stage surgery | One or two stage surgery | One or two stage surgery | |
| Structure | • Internal hex connection
• Submerged fixture
• Tapered body shape
• 3 sided cutting edge with
self-tapping
• SA surface treatment | • Internal hex connection
• Submerged fixture
• Tapered body shape
• 3 sided cutting edge with
self-tapping
• SA surface treatment | • Internal hex connection
• Submerged fixture
• Tapered body shape
• 3 sided cutting edge with
self-tapping
• SA surface treatment | |
| Body
Diameter (D)
(mm) | 4.4, 4.8, 5.25
6.2* and 7.1* | 3.5, 3.75, 3.77, 4.2, 4.25,
4.45, 4.6, 4.63, 4.9, 5.0,
5.05, 5.08, 5.1, 5.92, 5.95,
6.0, 6.8 | 4.4, 4.8, 5.25, 6.2, 7.1 | |
| Length (mm) | 7.0, 8.5, 10.0, 11.5, 13.0,
15.0
- the 6.2 and 7.1mm body
diameter are not available in
the 15mm length | 6.2, 7.2, 8.7, 10.2, 11.7,
13.2, 15.2, 18.2 | 7.0, 8.5, 10.0, 11.5, 13.0,
15.0 | |
| Material | Pure Titanium Grade 4
(ASTM F67) | Pure Titanium Grade 4
(ASTM F67) | Pure Titanium Grade 4
(ASTM F67) | |
| Surface | SA | SA | SA | |
| Sterilization
Method | Radiation sterilization | Radiation sterilization | Radiation sterilization | |
| Shelf life | 8 years | 8 years | 8 years | |
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 letters in gray. Below the word "Hiossen" is the word "Implant" in a smaller, gray font. Below the word "Implant" is the number "K183242" in black.
PAGE 4
Non-Clinical Performance Testing
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence include data from the following tests:
Biocompatibility Testing
The ET IV Dental Implants is manufactured using the same manufacturing process and material as the predicate device, Hiossen Implant System, K140934, therefore it was deemed not necessary to re-test biocompatibility in order to support the biological safety of the ET IV Implants System as there is no new worst-case as compared to K140934.
Sterilization Validation
The ET IV Dental Implants (manufactured using the same manufacturing process, material and utilizes the same sterilize barrier system) is gamma irradiated under the same conditions and process as the predicate device. Hiossen Implant System. K140934. therefore was deemed not necessary to re-validate in order to support the sterilization validity of the ET IV Dental Implants System as there is no new worst-case as compared to K140934.
Fatigue Testing
The ET IV Dental Implants is manufactured using the same manufacturing process, material and structure, as the predicate device, Hiossen Implant System, K140934, we deemed it was not necessary to re-test fatigue testing. The fatigue test data of the ø 3.5 Hiossen Implant System, K140934 which was conducted per ISO 14801:2007 Dentistry - Implants - Dynamic Fatigue Test for Endosseous Dental Implants, is applicable to the ET IV Dental Implants as there is no new worst-case as compared to K140934.
Conclusion
The ET IV SA Dental Implants are modified Hiossen Implant System – ET III SA Fixture and ET III SA Ultrawide Fixture (K140934) where the modification does not affect or change the intended use of the device or the fundamental scientific technology of the device. It has the same indication for use, surgery type, structure, material, surface, sterilization method, and shelf life with the primary predicate device Hiossen Implant System (K140934). Based on the testing provided, biocompatibility, sterilization and fatique, support that the ET IV SA Dental Implants is substantial equivalent to the predict device, Hiossen Implant System, K140934 and reference device, Osstem Implant System, K161604. Any differences in characteristics between the proposed device and the primary predicate and reference does not raise different or additional questions of substantial equivalence.