(147 days)
The Osstem Implant is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Ultra Wide Fixture System is intended to be used in the molar region.
The SS SA Fixture is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated.
This document is a 510(k) Premarket Notification from Osstem Implant Co., Ltd. to the FDA for their "SS SA Fixture" dental implant. It aims to demonstrate substantial equivalence to legally marketed predicate devices rather than proving the device meets specific acceptance criteria through a study with performance metrics as one might see for a diagnostic AI device.
Therefore, the requested information elements (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study, standalone performance, ground truth types, training set size, and training ground truth establishment) are generally not applicable in the context of this 510(k) submission for a non-AI dental implant.
However, I can extract information related to the device's technical specifications and the non-clinical testing performed to establish substantial equivalence.
Here's an adaptation of the requested format based on the available information:
1. A table of acceptance criteria and the reported device performance
For a dental implant, "acceptance criteria" usually refers to meeting established standards (e.g., ISO, ASTM) and demonstrating equivalence to predicate devices, rather than specific performance metrics like sensitivity/specificity for an AI algorithm. The device performance is primarily assessed through non-clinical testing to ensure its physical and mechanical properties are comparable or superior to the predicate.
| Acceptance Criterion (Based on predicate equivalence and applicable standards) | Reported Device Performance (SS SA Fixture) |
|---|---|
| Material Composition (Pure Titanium Grade 4 per ASTM F67) | Same as Predicate: Pure Titanium Grade 4 (ASTM F67) |
| Surface Treatment (SA - Sandblasted and Acid etched) | Same as Predicate: SA surface treatment. No change from predicate. |
| Sterilization (Radiation Sterile) | Same as Predicate: Radiation Sterile. No change from predicate. |
| Shelf Life (Compared to predicate) | Same as Reference Predicate: 8 years (Primary Predicate was 5 years, Reference Predicate was 8 years). |
| Biocompatibility (As established for predicate material and processes) | No additional testing required: Material of construction and manufacturing processes are the same as predicate devices (ET/SS Implant System, K120847 and OSSTEM Implant System, K161604). |
| Bone to Implant Contact (BIC) Value (Comparable to predicate device with similar lengths) | Substantial equivalence confirmed: BIC analysis conducted for implants < 7mm. Compared BIC value and confirmed substantial equivalence with ET/SS Implant System (K120847). |
| Surface Area Analysis (Comparable to predicate device with similar lengths) | Substantial equivalence confirmed: Surface area analysis conducted for implants < 7mm. Compared surface area and confirmed substantial equivalence with ET/SS Implant System (K120847). |
| Pullout Force Value (Comparable to predicate device with similar lengths) | Substantial equivalence confirmed: Pullout force test conducted for implants < 7mm. Compared pullout force value and confirmed substantial equivalence with ET/SS Implant System (K120847). |
| Fatigue Performance (Meet ISO 14801; considered against worst-case scenario and predicate) | Deemed superior/not requiring additional testing: SS SA Fixture has bigger diameter than primary predicate (ET/SS Implant System, K120847). The result of static and dynamic compression-bending test is expected to be higher than this predicate, thus no additional fatigue test was considered necessary. Testing was considered according to "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801. |
| Indications for Use (Comparable to predicate devices) | Same as Predicate: The indications for use are substantially equivalent to the predicate devices, with the addition of "Ultra Wide Fixture System is intended to be used in the molar region." |
| Structural Characteristics (E.g., Non Submerged, Self-tapping, Internal Octagonal connection, Taper Body) | Same as Predicate: Has same connection structure, material, manufacturing process, principles of operation, and technological characteristics as ET/SS Implant System (SSII/III SA Fixture). Some dimensions (diameter) are larger than the primary predicate but are included in the range of the reference predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set (for non-clinical studies): Specific sample sizes for each non-clinical test (BIC, Surface Area, Pullout, Fatigue) are not explicitly stated in the summary, only that these tests were conducted "with SS SA Fixture containing implants of lengths less than 7mm." The data provenance is implied to be from the manufacturer's internal testing. This is not patient data, but material/device performance data.
- Data Provenance: Not applicable in the sense of patient data origin as these are non-clinical (laboratory/bench) tests.
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 510(k) for a physical medical device, not a diagnostic AI device requiring expert-established ground truth from images or clinical data. The "ground truth", in this context, refers to established engineering and material science standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for non-clinical bench testing of a physical device.
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
- Not applicable. This is not an AI-based device, and no clinical studies were submitted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's evaluation relies on:
- Regulatory Standards: Compliance with FDA regulations (21 CFR Part 872.3640), Class II Special Controls, and international standards (e.g., ISO 14801 for fatigue testing, ASTM F67 for material).
- Predicate Device Equivalence: The established safety and effectiveness of the legally marketed predicate devices (K120847, K161604).
- Scientific Principles: Established principles of biocompatibility, mechanical engineering, and material science.
8. The sample size for the training set
- Not applicable. This is a physical device, not an AI model, and therefore does not have a "training set."
9. How the ground truth for the training set was established
- Not applicable. No training set as it's not an AI model.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 a caduceus, which is a symbol often associated with healthcare and medicine. The caduceus is depicted with three intertwined strands and a wing-like shape at the top.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 15, 2017
Osstem Implant Co., Ltd. % David Kim Manager Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030
Re: K163557
Trade/Device Name: SS SA Fixture Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: April 14, 2017 Received: April 14, 2017
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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
the quality systems (OS) 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.
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K163557
Device Name SS SA Fixture
Indications for Use (Describe)
The Osstem Implant is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Ultra Wide Fixture System is intended to be used in the molar region.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary
Date: May 11, 2017
1. Company and Correspondent making the submission:
| - Submitter's Name: | OSSTEM Implant Co., Ltd. |
|---|---|
| - Address: | 66-16, Bansong-ro 513beon-gil, Haeundae-gu,Busan, Republic of Korea |
| - Contact: | Mr. Hee Kwon Son |
| - Phone: | +82 51 850 2575 |
| - Correspondent's Name: | HIOSSEN Inc. |
| - Address: | 85 Ben Fairless Dr. Fairless Hills, PA 19030 |
| - Contact: | DAVID KIM |
| - Phone: | 267 759 7031 |
-
- Device:
Trade or (Proprietary) Name : SS SA Fixture Common or usual name : Dental Implant Classification Name : Endosseous Dental Implant Regulation Number : 21CFR872.3640 Device Classification: Class II Primary Product Code: DZE Subsequent Product Code: NHA
- Device:
-
- Predicate Device:
Substantial equivalence is claimed to the following devices: Primary Predicate K120847, ET/SS Implant System, OSSTEM Implant Co., Ltd.
- Predicate Device:
Reference predicate K161604, OSSTEM Implant System, OSSTEM Implant Co., Ltd.
4. Description:
The SS SA Fixture is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated.
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The logo is on the left side of the image, and the company name is in large, bold letters. The address is 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea. The telephone number is +82 51 850-2500, the fax number is +82 51 850-4341, and the website address is www.osstem.com.
The SS SA Fixture is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
1) SSIII SA Ultra-Wide Fixture
| DeviceDescription | Intended to be surgically placed in the bone of the upper or lower jawarches. Fixture is supplied sterile. Only straight type abutments are tobe used with the Ultra-Wide Fixture System. | |
|---|---|---|
| Material | Pure Titanium (ASTM F 67) | |
| Surface | SA surface treatment | |
| Diameter (mm) | Length (mm) | |
| Dimension | 5.96, | 6, 8.5 |
| 6.0 | 7 | |
| 5.95 | 10 | |
| 5.92 | 11.5, 13 | |
| 6.93 | 6 | |
| 6.8 | 7, 8.5, 10, 11.5, 13 |
- Substantial Equivalence Matrix
| SS SA Fixture(SSIII SA Ultra WideFixture) | Primary PredicateET/SS ImplantSystem(SSII/III SA Fixture) | Reference predicateOSSTEM ImplantSystem | ||
|---|---|---|---|---|
| 510(K) No. | New Device | K120847 | K161604 | |
| Manufacturer | OSSTEM ImplantCo., Ltd. | OSSTEM ImplantCo., Ltd. | OSSTEM ImplantCo., Ltd. | Same |
| Indication foruse | The Osstem Implant isindicated for use inpartially or fullyedentulous mandiblesand maxillae, in supportof single or multiple-unit restorationsincluding; cementedretained, screw retained,or overdenturerestorations, and final ortemporary abutmentsupport for fixedbridgework. It isintended for delayedloading. Ultra WideFixture System isintended to be used inthe molar region. | ET/SS Implant Systemis indicated for use inpartially or fullyedentulous mandiblesand maxillae, in supportof single or multiple-unit restorationsincluding; cementedretained, screw retained,or overdenturerestorations, and final ortemporary abutmentsupport for fixedbridgework. It isintended for delayedloading. The abutmentis intended for use witha dental implant fixtureto provide support forprosthetic restorations | The Osstem ImplantSystem is indicated foruse in partially or fullyedentulous mandiblesand maxillae, in supportof single or multiple-units restorationsincluding; cementedretained, screw retained,or overdenturerestorations, and final ortemporary abutmentsupport for fixedbridgework. It isintended for delayedloading. Ultra wideFixture System isintended to be used inthe molar region.Products with diameter | Same |
| such as crowns, bridges,or overdenture. | of less than 3.25mmshould be usedexclusively for thelateral incisor in themaxilla and a central orlateral incisor in themandible | |||
| Surgery type | One stage Surgery | One stage Surgery | One or two stageSurgery | Same |
| Structure | - Non SubmergedFixture- Self tapping- Internal Octagonalconnection- Taper Body | - Non SubmergedFixture- Self tapping- Internal Octagonalconnection- Straight/Taper bodyshape | - Internal Hex-connected- Submerged Fixture- Straight/Taper bodyshape | Same |
| Platform(D) (mm) | 6 | 4.8~6.0 | N/A | Included inpredicate |
| BodyDiameter(D) (mm) | 5.92, 5.95, 5.96, 6.0,6.93, 6.8 | 4.1 | 3.2, 3.5, 3.75, 3.77, 4.2,4.25, 4.4, 4.45, 4.6,4.63, 4.65, 4.8, 4.9,5.05, 5.08, 5.1, 5.25,6.2, 7.1 | Included inReferencepredicate |
| Length (mm) | 6, 7, 8.5, 10, 11.5, 13 | 6~15.0 | 6.2, 7.0, 8.5, 10.0, 11.5,13.0, 15.0, 18.0 | Included inpredicate |
| Material ofFixture | Pure Titanium Grade 4(ASTM F67) | Pure Titanium Grade 4(ASTM F67) | Pure Titanium Grade 4(ASTM F67) | Same |
| Surface | SA | SA | SA | Same |
| Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile | Same |
| Shelf life | 8years | 5years | 8years | Same withReferencepredicate |
| S E | SameSS SA Fixture have same connection structure, material, manufacture process (includingsurface treatment), principles of operation, Technological Characteristics and indication for usewith ET/SS Implant System (SSII/III SA Fixture)And length of SS SA Fixture is also included in primary predicate ET/SS Implant System(SSII/III SA Fixture)DifferentDiameter of SS SA fixture is bigger than primary predicate ET/SS Implant System (SSII/III SAFixture) but Diameter of SS SA fixture is included in range of reference predicate diameter,OSSTEM Implant System.Therefore SSIII SA Ultra Wide Fixture of SS SA Fixture is substantially equivalent to thepredicate devices |
Letter(8.5 X 11in)
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for Osstem Implant. The logo is orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. There is a small superscript "6" next to the word "OSSTEM".
OSSTEM Implant Co., Ltd.
Section 007
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
5. Indication for use:
The Osstem Implant 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
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The address is 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea. The phone number is +82 51 850-2500, the fax number is +82 51 850-4341, and the website is www.osstem.com.
fixed bridgework. It is intended for delayed loading. Ultra Wide Fixture System is intended to be used in the molar region.
6. Summary of nonclinical testing
The following nonclinical testing data were provided or relied upon in support of the Substantial equivalence determination.
Biocompatibility
Biocompatibility testing on the SS SA Fixture was previously conducted. As the material of construction and manufacturing processes are the same as the predicate device, ET/SS Implant System, OSSTEM Implant Co., Ltd., K120847 and OSSTEM Implant System, OSSTEM Implant Co., Ltd., K161604.
Therefore, no additional testing is required to support the biological safety of the subject devices.
Sterilization validation
Validation of the gamma irradiation process was previously conducted for the predicate devices, OSSTEM Implant System, OSSTEM Implant Co., Ltd., K161604. There has been no change to the manufacturing, sterilization processes since then; therefore, additional validation is not required.
Surface treatment characterization testing
SS SA Fixture has SA (Sandblasted and Acid etched surface) surface treatment that is exactly same with the predicate devices, ET/SS Implant System, OSSTEM Implant Co., Ltd., K120847 and OSSTEM Implant System, OSSTEM Implant Co., Ltd., K161604. There has been no change to the manufacturing or surface treatment processes since then; therefore, additional characterization testing is not required.
Bone to Implant Contact (BIC) analysis
BIC analysis is conducted with SS SA Fixture containing implants of lengths less than 7mm. We compared the BIC value and confirmed the substantial equivalence status with the predicate device; ET/SS implant System, OSSTEM Implant Co., Ltd., K120847.
Surface area analysis
Surface area analysis is conducted with SS SA Fixture containing implants of lengths less than 7mm. We compared the surface area and confirmed the substantial equivalence status with the predicate device; ET/SS implant System, OSSTEM Implant Co., Ltd., K120847.
Pullout test
Pullout force test was conducted with SS SA Fixture containing implants of lengths less than 7mm. We compared the pullout force value and confirmed the substantial equivalence status with the predicate device; ET/SS implant System, OSSTEM Implant Co., Ltd., K120847.
{7}------------------------------------------------
Image /page/7/Picture/1 description: The image contains two logos. The first logo on the left says "OSSTEM IMPLANT" with "OSSTEM" in orange and "IMPLANT" in gray. The second logo on the right says "OS" in large black font, followed by the number "66-16."
Fatigue test
The Fatigue testing was considered according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801 Dentistry - Fatigue test for endosseous dental implants with the worst case scenario. SS SA Fixture has bigger diameter than the predicate device, ET/SS Implant System, OSSTEM Implant Co., Ltd., K120847. The result of SS SA Fixture static and dynamic compression - bending test will be higher than this predicate; therefore, we do not consider additional fatigue test.
-
- Summary of clinical testing No clinical studies are submitted.
-
- 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 Osstem Implant Co., Ltd. concludes that the SS SA Fixture 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.