(147 days)
No
The document describes a dental implant made of titanium and its mechanical properties and testing. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML.
Yes
The device is a dental implant used for supporting restorations in edentulous areas, which is a form of treatment to restore dental function and aesthetics.
No
The device, an Osstem Implant, is described as a dental implant for supporting restorations in the mandible and maxillae, intended for surgical placement. Its function is to replace missing teeth, not to diagnose medical conditions or diseases.
No
The device description explicitly states it is a dental implant made of titanium metal, which is a physical hardware component. The performance studies also focus on physical properties and testing of the implant itself.
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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device description and intended use: The description clearly states that the Osstem Implant is a dental implant made of titanium metal intended to be surgically placed in the bone of the jaw. Its purpose is to support dental restorations.
- Lack of mention of samples or testing: There is no mention of the device being used to analyze samples or perform any kind of diagnostic test on bodily fluids or tissues.
The device is a surgically implanted medical device used for structural support in dental procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications 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 fixed bridgework. It is intended for delayed loading. Ultra Wide Fixture System is intended to be used in the molar region.
Product codes
DZE, NHA
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Nonclinical testing data were provided or relied upon.
- Biocompatibility: Previously conducted, no additional testing required as material and manufacturing processes are same as predicate.
- Sterilization validation: Previously conducted for predicate devices, no change in manufacturing or sterilization processes, so no additional validation required.
- Surface treatment characterization testing: SS SA Fixture has SA surface treatment exactly same as predicate devices, no change in manufacturing or surface treatment processes, so no additional characterization testing required.
- Bone to Implant Contact (BIC) analysis: Conducted with SS SA Fixture containing implants of lengths less than 7mm. BIC value compared to predicate device K120847 to confirm substantial equivalence.
- Surface area analysis: Conducted with SS SA Fixture containing implants of lengths less than 7mm. Surface area compared to predicate device K120847 to confirm substantial equivalence.
- Pullout test: Pullout force test conducted with SS SA Fixture containing implants of lengths less than 7mm. Pullout force value compared to predicate device K120847 to confirm substantial equivalence.
- Fatigue test: 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 Dentistry - Fatigue test for endosseous dental implants with the worst case scenario. No additional fatigue test considered necessary as the SS SA Fixture has a bigger diameter than the predicate device (K120847) and its static and dynamic compression-bending test results are expected to be higher.
No clinical studies were submitted.
Key Metrics
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.
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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) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
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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
| Device
Description | Intended to be surgically placed in the bone of the upper or lower jaw
arches. Fixture is supplied sterile. Only straight type abutments are to
be 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 Wide
Fixture) | Primary Predicate
ET/SS Implant
System
(SSII/III SA Fixture) | Reference predicate
OSSTEM Implant
System | |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| 510(K) No. | New Device | K120847 | K161604 | |
| Manufacturer | OSSTEM Implant
Co., Ltd. | OSSTEM Implant
Co., Ltd. | OSSTEM Implant
Co., Ltd. | Same |
| 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 fixed
bridgework. It is
intended for delayed
loading. Ultra Wide
Fixture System is
intended to be used in
the molar region. | ET/SS 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. The abutment
is intended for use with
a dental implant fixture
to provide support for
prosthetic restorations | The Osstem Implant
System is indicated for
use in partially or fully
edentulous mandibles
and maxillae, in support
of single or multiple-
units 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 | Same |
| | | such as crowns, bridges,
or overdenture. | of less than 3.25mm
should be used
exclusively for the
lateral incisor in the
maxilla and a central or
lateral incisor in the
mandible | |
| Surgery type | One stage Surgery | One stage Surgery | One or two stage
Surgery | Same |
| Structure | - Non Submerged
Fixture
- Self tapping
- Internal Octagonal
connection - Taper Body | - Non Submerged
Fixture - Self tapping
- Internal Octagonal
connection - Straight/Taper body
shape | - Internal Hex-
connected - Submerged Fixture
- Straight/Taper body
shape | Same |
| Platform
(D) (mm) | 6 | 4.86.0 | N/A | Included in4.9/3.75
predicate |
| Body
Diameter
(D) (mm) | 5.92, 5.95, 5.96, 6.0,
6.93, 6.8 | 4.15.0 | 3.2, 3.5, 3.75, 3.77, 4.2,15.0 | 6.2, 7.0, 8.5, 10.0, 11.5,
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 in
Reference
predicate |
| Length (mm) | 6, 7, 8.5, 10, 11.5, 13 | 6
13.0, 15.0, 18.0 | Included in
predicate |
| Material of
Fixture | 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 with
Reference
predicate |
| S E | Same
SS SA Fixture have same connection structure, material, manufacture process (including
surface treatment), principles of operation, Technological Characteristics and indication for use
with 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)
Different
Diameter of SS SA fixture is bigger than primary predicate ET/SS Implant System (SSII/III SA
Fixture) 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 the
predicate 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.
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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.