(343 days)
The ETIII SA Fixture System (03.2mm) 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.
The ETIII SA Fixture System (Ø3.2) is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. 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.
This document is a 510(k) premarket notification for the ETIII SA Fixture System (Ø3.2mm) to the FDA. It declares substantial equivalence to existing predicate devices, rather than presenting a study to prove a device meets acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study to prove it cannot be found in this document.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This document does not present specific acceptance criteria or performance metrics for the ETIII SA Fixture System (Ø3.2mm) in the way one would expect for a new diagnostic or AI-driven device. Instead, it aims to demonstrate "substantial equivalence" to existing, legally marketed predicate devices. The "performance" is implicitly deemed equivalent to these predicates.
- The document does list various tests conducted, such as biocompatibility tests (Subchronic Toxicity, Bacterial reverse mutation, Chromosome aberration, Cytotoxicity, Skin sensitization, Oral Mucosa Irritation, Acute Systemic Toxicity, Pyrogen tests), sterility tests, and mechanical tests (adaptation accuracy, static and dynamic fatigue). However, it does not provide specific numerical outcomes or acceptance thresholds for these tests that could be presented in a performance table. It merely states that "All tests were conducted in accordance with relative standards without any discrepancies."
2. Sample size used for the test set and the data provenance
- Not Applicable. This document describes a medical device (dental implant), not a software or AI device that would typically have a "test set" in the context of data analysis. The testing involved material properties, biocompatibility, and mechanical performance, not a clinical data set for algorithm validation.
- Therefore, there is no information on sample size for a "test set" as would be relevant for an AI study, nor data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. As this is a physical medical device (dental implant) and not an AI or diagnostic software, there is no "ground truth" established by experts in the context of data labeling or diagnosis for a test set. The validation relies on standard engineering, material, and biological safety testing.
4. Adjudication method for the test set
- Not Applicable. No test set or adjudication method as typically defined for AI or diagnostic studies is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This document pertains to a physical dental implant, not an AI or diagnostic tool, so an MRMC study is not relevant and was not conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For the physical properties and safety of a dental implant, the "ground truth" is established through adherence to recognized international standards (e.g., ISO, ASTM, USP) for material science, biocompatibility, and mechanical testing. There isn't a "ground truth" in the sense of clinical diagnosis or outcomes data detailed here for a study to prove acceptance criteria.
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not applicable.
Summary based on the document:
The document describes the ETIII SA Fixture System (Ø3.2mm) dental implant and seeks FDA clearance based on substantial equivalence to predicate devices. It references various non-clinical tests performed in accordance with international standards (ISO, USP) to demonstrate safety and performance, but does not provide the specific results or acceptance criteria values for these tests. It explicitly states, "No clinical studies are submitted." The focus is on demonstrating that the new device has the same intended use, similar technological characteristics, and comparable safety and effectiveness as legally marketed predicate devices, rather than establishing specific performance metrics against pre-defined acceptance criteria for a novel technology.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 27, 2016
HiOSSEN Inc. David Kim Manager 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030
Re: K153332
Trade/Device Name: ETIII SA Fixture System (Ø 3.2mm) Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 27, 2016 Received: September 28, 2016
Dear David Kim:
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. 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.
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
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 007
Image /page/2/Picture/1 description: The image shows the logo and contact information for Hiossen Inc. The logo features the company name in a stylized font, with the "H" in red and the rest of the name in gray. Below the logo is the company name, address (85 Ben Fairless Dr. Fairless Hills, PA 19030), phone number (1-888-678-0001), fax number (1-267-759-7004), and website address (www.hiossen.com).
Indications for Use Statement
510(k) Number K ______________________________________________________________________________________________________________________________________________________________
Device Name : The ETIII Fixture System (Ø3.2mm)
Indication for use :
The ETIII SA Fixture System (03.2mm) 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.
Prescription Use X (Per 21CFR801 Subpart D) OR Over-The-Counter Use (Per 21CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Section 008
Image /page/3/Picture/1 description: The image shows the logo for Hiossen. The logo is in two colors, red and gray. The letters "HI" are in red, and the rest of the letters are in gray.
Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com
510(k) Summary
This summary of 510(k) substantial equivalence information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date : Sept. 27, 2016
- Company and Correspondent making the submission:
| - Submitter's Name : | HiOSSEN Inc. |
|---|---|
| - Address : | 85 Ben Fairless Dr.Fairless Hills PA 19030 |
| - Telephone No. | 888 678 0001 |
| - Contact : | Mr. David Kim |
2. Device :
| Trade or (Proprietary) Name : | ETIII SA Fixture System (Ø3.2) |
|---|---|
| Common or usual name : | Endosseous Dental Implant |
| Regulation Number: | 21 CFR 872.3640 |
| Regulation Name: | Endosseous Dental Implant |
| Regulatory Class: | Class II |
| Product Code: | DZE, NHA |
3. Predicate Device:
Primary Predicate: HIOSSEN IMPLANT SYSTEM (HIOSSEN Inc., K140934) Referenced Predicate #1: MS SA IMPLANT SYSTEM (HIOSSEN Inc., K122171) Referenced Predicate #2: NobelActive 3.0 ( NobelBiocare, K102436 )
4. Description :
-
- The ETIII SA Fixture System (Ø3.2) is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
-
- 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.
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Image /page/4/Picture/0 description: The image shows the logo for HIOSSEN. The letters "HI" are in red, and the rest of the letters are in gray. There is a red swoosh above the "HI".
Section 008
Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com
3) Fixture
| Device | Intended to be surgically placed in the bone of the upper or lower jaw arches. | ||
|---|---|---|---|
| Description | Fixture is supplied sterile. | ||
| Material | Alloyed Titanium (ASTM F136) | ||
| Surface | SA surface treatment (Sand blasted and Acid etched ) | ||
| Diameter (mm) | Length (mm) | Connection | |
| Dimension | 3.2 | 8.7, 10.2, 11.7, 13.2, 15.2 | Mini |
4) Component
| Mount Set | |
|---|---|
| Description | To be used for easy implanting of the Fixture |
| Material | Alloyed Titanium (ASTM F136) |
| Diameter (mm) | 4.8 |
| Length (mm) | 16 |
| Connection | Mini |
| Cover Screw | |
| Description | To be used to protect the exposed platform of the implant during healing period. |
| Material | Pure Titanium (ASTM F 67) |
| Diameter (mm) | 3.1 |
| Length (mm) | 4.75 |
| Connection | Mini |
Substantial Equivalence
| Proposed device | Primarypredicate device | Referencepredicate device | Referencepredicate device | |
|---|---|---|---|---|
| ETIII SA FixtureSystem (Ø3.2mm) | Hiossen ImplantSystem | MS SA ImplantSystem | NobelActive 3.0 | |
| Design | Image: ETIII SA Fixture System (Ø3.2mm) | Image: Hiossen Implant System | Image: MS SA Implant System | Image: NobelActive 3.0 |
| 510(K) No. | N/A | K140934 | K122171 | K102436 |
| www.hiossen.com | ||||
| Indicationfor use | The ETIII SA FixtureSystem (Ø3.2mm) isindicated for use inmandibular andmaxillary lateral andcentral incisor, insupport of single ormultiple-unitrestorations including;cemented retained,screw retained, oroverdenturerestorations, and finalor temporaryabutment support forfixed bridgework. It isintended for delayedloading. | The HIOSSEN ImplantSystem is indicated foruse in partially or fullyedentulous mandiblesand maxillae, in supportof single or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and final ortemporary abutmentsupport for fixedbridgework. It is intendedfor delayed loading.ETIII SA Ultra-WideFixture is intended to beused in the molar region. | The MS SA Implant(Narrow Ridge) isintended to use in thetreatment of missingmandibular central andlateral incisors to supportprosthetic device, such asartificial teeth, in order torestore chewing functionin partially edentulouspatients. The MS SAImplant (Narrow Ridge)is intended for single useonly. It is intended fordelayed loading. | The NobelActive3.0mm implant isindicated for use in thetreatment of missingmaxillary lateral incisorsor the mandibularcentral and lateralincisors to supportprosthetic devices, suchas artificial teeth,inorder to restore chewingfunction in partiallyedentulous patients. TheNobelActive 3.0implants may be put intoimmediate functionprovided that stabilityrequirements detailed inthe manual are satisfied. |
| Surgery type | One or two stageSurgery | One and two stageSurgery | One stageSurgery | One and two stageSurgery |
| Structure | - Internal Hex- Bone Level Implant- Straight body shape- 3 sided cutting edgewith self-tapping | - Internal Hex- Bone Level Implant- Tapered body shape- 3 sided cutting edgewith self-tapping | - One Body Implant- Straight body shape- Threaded bodydesign- 2 sided cutting edge | -Internal Hex- Bone Level Implant |
| BodyDiameter | 3.2 mm | 3.5, 3.75, 3.77, 4.2, 4.25,4.45, 4.6, 4.63, 4.65, 4.9,5.0, 5.1, 5.05, 5.08, 5.92,5.95, 6.8 mm | 2.5, 2.9 mm | 3.0 mm |
| Length | 8.7, 10.2, 11.7, 13.2,15.2 mm | 6.2, 7.2, 8.2, 8.7, 9.7,10.2, 11.2, 11.7, 12.7,13.2, 15.2, 18.2 mm | 8.5, 10, 11.5, 13 mm | 10, 11.5, 13, 15 mm |
| Material ofFixture | Titanium AlloyTi-6Al-4V(ASTM F136) | Pure Titanium Grade 4(ASTM F67) | Titanium AlloyTi-6Al-4V(ASTM F136) | Pure Titanium Grade 4(ASTM F67) |
| Surface | SA(Sandblasting& Acid etching) | SA(Sandblasting& Acid etching) | SA(Sandblasting& Acid etching) | TiUnite |
| Steriliza-tion | Radiation Sterile | Radiation Sterile | Radiation Sterile | Radiation Sterile |
| Shelf life | 8years | 8years | 8 years | n/a |
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Image /page/5/Picture/0 description: The image shows the logo for HIOSSEN. The logo is in two colors, red and gray. The letters "HI" are in red, and the rest of the word "OSSEN" is in gray. There is a red swoosh above the "HI".
Hiossen Inc.
85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com
Section 008
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Image /page/6/Picture/0 description: The image shows the logo for Hiossen. The letters "HI" are in red, with a red swoosh above the "H". The rest of the word, "OSSEN", is in gray. The logo is simple and modern.
Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com
| Differences | The indications for use:The indication for use statement for the proposed device is not identical to the predicate device(K140934);however, the difference does not alter the general intended use of dental implant. Both the subject andpredicate devices have the same intended use for the replacement of missing teeth. And the indication foruse of proposed device is very similar with predicate device, K102436.Material:The proposed device is made with alloyed titanium (Ti-6Al 4V) and the predicate device, K140934 is madewith pure titanium (Ti CP4). The difference in material is insignificant chemical composition. And anotherpredicate device, K122171 is made with alloyed titanium(Ti-6Al-4V) |
|---|---|
| SimilaritiesAndS.E | Proposed device, ETIII SA Fixture System (Ø3.2mm) is same with predicate devices in intendeduse (K140934 / K102436), material (K122171 ), and surface treatment (K140934 ). |
-
- Indication for use :
The ETII 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.
- Indication for use :
-
- Summary of nonclinical testing
Hiossen predicate K140934 was relied upon for sterility, shelf-life and biocompatibility. Additionally LAL testing per USP <85> was conducted for the subject device.
- Summary of nonclinical testing
Non-clinical testing data submitted to demonstrate substantial equivalence includes adaptation accuracy for rotation angle and gap, static and dynamic fatigue test according to "Guidance for industry and FDA staff Class Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" All tests were conducted in accordance with relative standards without any discrepancies.
| Test Items | Standard |
|---|---|
| Subchronic Toxicity test ( ISO 90 Days, Bone ) | ISO 10993-11 , ISO 10993-6 |
| Bacterial reverse mutation test (Genotoxicity test) | ISO 10993-3, ISO 10993-12 |
| Chromosome aberration test (Genotoxicity test) | ISO 10993-3, ISO 10993-12 |
| Cytotoxicity test | ISO 10993-5, ISO 10993-12 |
| Sterility test | USP 36 <71> |
| Skin sensitization test (GPMT) | ISO 10993-10 |
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Image /page/7/Picture/0 description: The image shows the word "HIOSSEN" in a stylized font. The "HI" is in red, and the rest of the word is in gray. There is a red swoosh above the "I" in "HI".
Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com
| Oral Mucosa Irritation test | ISO 10993-10 |
|---|---|
| Acute Systemic Toxicity test | ISO 10993-11 |
| Pyrogen test | ISO 10993-11, USP 36 <151> |
- Summary of clinical testing No clinical studies are submitted.
8. Conclusions
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 that the The ETIII SA Fixture System (Ø3.2) is substantially equivalent to the predicate devices as described herein.
§ 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.