(289 days)
The US SA 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 such as bridges, or overdenture.
The US SA Implant System 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. The US Multi Angled Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration.
The provided text describes a 510(k) premarket notification for the "US SA Implant System," a dental implant device. The document focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than establishing acceptance criteria or reporting performance from a clinical study for a new device on its own merits against specific criteria.
Therefore, many of the requested details about acceptance criteria, specific device performance numbers, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance are not directly applicable or available in this type of submission document.
However, I can extract information related to the non-clinical testing performed to support the substantial equivalence claim.
Here's a breakdown of the information that can be gleaned from the document based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document in the format of specific numerical acceptance criteria and corresponding device performance metrics. The document instead focuses on demonstrating substantial equivalence through comparison of materials, design, indications for use, and non-clinical testing results against predicate devices. The fatigue testing was conducted according to a guidance document, implying the device met the requirements outlined in that guidance, but specific numerical thresholds and results are not detailed.
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not specified. The document states "fatigue testing was conducted." The number of devices or iterations in this testing is not mentioned.
- Data provenance: The testing was conducted by the manufacturer, OSSTEM IMPLANT Co., Ltd., likely in a laboratory setting. The country of origin for this specific testing is implied to be Republic of Korea, where the company is based. The nature of the testing is non-clinical (laboratory).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This relates to clinical studies and human interpretation of data. The submission focuses on non-clinical engineering testing (fatigue, sterilization).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This relates to clinical studies and human interpretation of data.
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, an MRMC study was not done. This type of study is for comparing human performance, often in diagnostic imaging, with and without AI. This submission is for a dental implant, which is a physical device, and does not involve AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical dental implant, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the fatigue testing, the "ground truth" would be the engineering standards and requirements for mechanical strength and durability of dental implants, aligned with ISO standards and FDA guidance. The determination of "success" or "failure" would be based on whether the device passed these mechanical tests without fracture or significant deformation.
- For sterilization validation, the "ground truth" is established by adherence to recognized international standards (ISO 11137 series for gamma sterilization and ISO 17665 series for steam sterilization), demonstrating acceptable sterility assurance levels.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is a physical device, not an AI model or a system that requires machine learning training.
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no training set for this type of device submission.
Summary of Non-Clinical Testing Performed (from the document):
- Fatigue testing: Conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment." This testing confirms the mechanical strength and durability of the implant and abutment components. The document indicates that a fatigue test was specifically performed for the US Multi Angled Abutment due to differences in connection structure and shape compared to a predicate, to confirm its strength.
- Gamma Sterilization Validation: Performed with the Fixture System according to ISO 11137-1, ISO 11137-2, and ISO 11137-3.
- Steam Sterilization Validation: Provided according to ISO 17665-1 and ISO 17665-2.
- Biocompatibility and Surface Coating Characterization: The document states that the subject devices are made of the same materials, manufacturing process, chemical composition, and body contact as predicate devices (TS Fixture System, K121995 and Multi Angled Abutment, K123755), thus demonstrating substantial equivalence in these areas.
In conclusion, this 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices through comparisons of design, materials, indications for use, and adherence to recognized non-clinical testing standards (fatigue, sterilization) rather than presenting a clinical study with detailed acceptance criteria and performance statistics for a completely novel device.
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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 an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 2, 2017
OSSTEM IMPLANT Co., Ltd. c/o Mr. David Kim Manager HiOSSEN Inc. 85 Ben Fairless Dr. Fairless Hills. Pennsylvania 19030
Re: K161103
Trade/Device Name: US SA Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: January 6, 2017 Received: January 6, 2017
Dear Mr. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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 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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Image /page/2/Picture/1 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The logo includes the company name and the word "IMPLANT" in orange. The address is listed as 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea, and the telephone number is +82 51 850-2500, the fax number is +82 51 850-4341, and the website is www.osstem.com.
Indications for Use Statement
Indications for Use
510(k) Number K 161103
Device Name : US SA Implant System
Indication for use : The US SA 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 such as bridges, or overdenture.
Prescription Use (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)
QS-QI-505-2(Rev.0)
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Image /page/3/Picture/1 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. The logo is simple and modern.
STEM Implant Co., Ltd.
6-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
510(k) Summary
Date: February 1, 2017
- 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 : | US SA Implant System |
|---|---|
| Common or usual name : | Dental Implant |
| Classification Name : | Endosseous Dental Implant |
| Regulation Number: | 21CFR872.3640 |
| Regulatory Class: | Class II |
| Product Code: | DZE, NHA |
-
- Predicate Device :
-
Primary predicate HU II / HS II FIXTURE SYSTEM, HiOSSEN Inc, K080387
-
Reference predicate
Multi Angled Abutment, OSSTEM Implant Co., Ltd., K123755 TS Fixture System, OSSTEM Implant Co., Ltd., K121995 US.SS.GS System, OSSTEM Implant Co., Ltd., K073247 3i OSSEOTITE Dental Implants, Implant Innovations, Inc, K063286 HIOSSEN Implant System, HIOSSEN Inc., K140934
4. Description :
The US SA Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
QS-QI-505-3(Rev.0)
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Image /page/4/Picture/1 description: The image shows the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, gray, sans-serif font. The logo is simple and modern.
OSSTEM Implant Co., Ltd.
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
Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated.
The US SA Implant System 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 US SA Implant System is substantially equivalent in design, function and intended use to the HU II / HS II Fixture System ( K080387) of Osstem Implant Co., Ltd., the TS Fixture System (K121995) of OSSTEM Implant Co., Ltd., the Multi Angled Abutment (K123755) of OSSTEM Implant Co., Ltd. and HIOSSEN Implant System (K140934) of HIOSSEN Inc.
The US Multi Angled Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration.
The US Multi Angled Abutment is used with Multi Ti Cylinder or US Esthetic Low Cylinder that is predicated by 510(K), K140507 Hiossen Prosthetic system and connected to USII SA Fixture and USIII SA Fixture. The US II SA and US III SA fixtures are only compatible with the straight Cemented Abutment and straight UCLA Temporary Abutment from K073247 and the US Multi Angled Abutment included in this submission.
| Item | Content | ||
|---|---|---|---|
| US II SA Fixture | Description | External Hex-connectedSubmerged FixtureStraight body shape3 side cutting edge with self-tapping | |
| Material | Titanium (ASTM F67) | ||
| Diameter and Length | 3.5mm X 8.5, 10, 11.5, 13, 15, 18 mm4.1mm X 7, 8.5, 10, 11.5, 13, 15, 18 mm4.45mm X 7, 8.5, 10, 11.5, 13, 15, 18 mm4.9mm X 7, 8.5, 10, 11.5, 13, 15, 18 mm (wide)4.9mm X 7, 8.5, 10, 11.5, 13, 15, 18 mm (wide ps) | ||
| US III SA Fixture | Description | External Hex-connectedSubmerged FixtureTaper body shape3 sided cutting edge with self-tapping | |
| Material | Titanium (ASTM F67) | ||
| Diameter and Length | 3.75mm X 8.5, 10, 11.5, 13 mm4.23mm X 8.5, 10, 11.5 mm4.27mm X 7 mm4.65 mm X7, 8.5, 10, 11.5, 13 mm5.05mm X 10, 11.5 mm (wide)5.1mm X 7, 13 mm (wide)5.13mm X 8.5 mm (wide)5.05mm X 10, 11.5 mm (wide ps)5.1mm X 7, 13 mm (wide ps)5.13mm X 8.5 mm (wide ps) |
QS-QI-505-3(Rev.0)
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Image /page/5/Picture/0 description: The image features the logo for Osstem Implant. The logo is in orange and consists of the word "OSSTEM" in a bold, sans-serif font, with the superscript symbol. Below "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and modern, and the orange color is eye-catching.
OSSTEM Implant Co., Ltd.
OSSTEM Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haeunda-gu, Busan, Republic of Korea
Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
| Cover Screw | Description | To be used to protect the exposed platform of the implantduring healing period | |
|---|---|---|---|
| Material | Titanium (ASTM F67) | ||
| Diameter | 6.4mm, 7.7mm | ||
| Length | 5.9mm | ||
| US Multi AngledAbutment | Description | US Multi Angle Abutment is used to adjust path ofprosthesis for multi-unit restorations. | |
| Material | Titanium Alloy (ASTM F 136) | ||
| Component | US Multi Angled Abutment Screw. | ||
| Diameter | 3.4mm, 4.0mm, 4.1mm | ||
| Angle | 17°, 30° | ||
| Multi Ti Cylinder | Description | Multi Ti Cylinder is used to make final prosthesis usingUS Multi Angled Abutment | |
| Material | Titanium Alloy (ASTM F 136) | ||
| Component | Consists of Multi Ti Cylinder Screw. | ||
| Diameter | 4.8mm | ||
| Length | 7.0mm |
- Substantial Equivalence Matrix
| Predicate devices | ||||
|---|---|---|---|---|
| Primarypredicate | Referencepredicate | Referencepredicate | ||
| US SA ImplantSystemUSII SA FixtureUSIII SA Fixture | HUII/ HSIIFIXTURESYSTEMHUII Fixture(K080387) | TS FixtureSystemTSII/III SAFixture(K121995) | ET II SAFixture(K140934) | |
| Design | Image: USII and USIII | Image: HUII | Image: TSII and TSIII | Image: ETII |
| Intended use | The US SA ImplantSystem is indicatedfor use in partially orfully edentulousmandibles andmaxillae, in supportof single or multiple-unit restorationsincluding: cemented | The HUII / HSIIFixture System isindicated for use inpartially or fullyedentulousmandibles andmaxillae, in supportof single or multiple-unit restorations | The TS FixtureSystem is indicatedfor use in partially orfully edentulousmandibles andmaxillae, in supportof single or multiple-unit restorationsincluding : cemented | The ETII FixtureSystem is indicatedfor use in partially orfully edentulousmandibles andmaxillae, in supportof single or multiple-unit restorationsincluding: cemented |
| retained, screwretained, oroverdenturerestorations, and finalor temporaryabutmentsupport for fixedbridgework. It isintended for delayedloading.The abutment isintended for use witha dental implantfixture to providesupport for prosthetic | including;cemented retained,screw retained, oroverdenturerestorations, andterminal orintermediateabutment support forfixed bridgework.The HU II / HS IIFixture System is forone and two stagesurgical procedures.It is not forimmediate load. | retained, screwretained, oroverdenturerestorations, andfinal or temporaryabutmentsupport for fixedbridgework. It isintended for delayedloading | retained, screwretained, oroverdenturerestorations, andfinal or temporaryabutment support forfixed bridgework. Itis intended fordelayed loading.Ultra wide FixtureSystem is intended tobe used in the molarregion. | |
| restorations such asbridges, oroverdenture. | ||||
| Surgery type | One and two stageSurgery | One and two stageSurgery | One and two stageSurgery | One and two stageSurgery |
| Structure | - External Hex-connected- Submerged Fixture- Straight / Taperbody shape- 3 sided cutting edgewith self-tapping | -Submerged Fixture-Body type : StraightBody-Self tapping-Connection :External hex-connected | - Internal Hex-connected- Submerged Fixture- Straight / Taperbody shape- 3 sided cutting edgewith self-tapping | - Internal Hex-connected- Submerged Fixture- Straight bodyshape- 3 sided cuttingedge with self-tapping |
| Platform(D) | 3.6, 4.2, 5.1, 5.2 | 3.5~5.1 | N/A | N/A |
| BodyDiameter(D) | 3.5, 4.1, 4.45, 4.93.75, 4.23, 4.27,4.65, 5.05, 5.1, 5.13 | 3.5~5.5 | TS II SA: 3.5, 4.2,4.4, 4.9TS III SA: 3.77,3.75, 4.25, 4.2, 4.65,4.63, 4.6, 5.1, 5.08,5.05, | 3.5, 4.2, 4.45, 4.9,5.0 |
| Length (mm) | 7, 8.5, 10, 11.5, 13,15, 18 | 7.0~15.0 | 7.0~15 | 6.2 ~ 18.2 |
| Material ofFixture | Pure Titanium Grade4(ASTM F67) | Pure Titanium Grade4(ASTM F67) | Pure Titanium Grade4(ASTM F67) | Pure Titanium Grade4(ASTM F67) |
| Surface | SA | RBM | SA | SA |
| Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile | Radiation Sterile |
| Shelf life | 8years | 3 years | 8 years | 8 years |
| SE | USII SA Fixture and USIII SA Fixture have the same material, indication for use,connection structure as the HUII Fixture in the HU II / HS II Fixture System(K080387) except surface treatment.surface treatment of USII SA Fixture is different from Primary predicate, HUIIFixture but the surface treatment of USII SA Fixture and USIII SA Fixture is thesame with surface treatment of TS Fixture System (K121995) |
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Image /page/6/Picture/1 description: The image contains the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, gray, sans-serif font. There is a small orange circle with a degree symbol in the upper right corner of the logo.
OSSTEM Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haeunda-gu, Busan, Republic of Korea
Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
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Image /page/7/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. The logo is simple and modern.
OSSTEM Implant Co., Ltd.
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
And Diameter size and length of US SA Implant System are included dimension range of predicate, HUII Fixture in the HU II / HS II Fixture System (K080387) and ET II SA Fixture (K140934) Therefore we state that US SA Implant System is substantially equivalent to the predicate devices as described herein.
| US Multi AngledAbutment | Predicate devices | ||
|---|---|---|---|
| Primary predicateMulti Angled Abutment | Reference predicateCement Abutment | ||
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd |
| 510(k) Number | New | K123755 | K073247 |
| Design | Image: US Multi Angled Abutment Design | Image: Multi Angled Abutment Design | Image: Cement Abutment Design |
| Intended use | US Multi AngledAbutment is intended foruse with a dental implantto provide support forprosthetic restorationssuch as bridges, oroverdentures. | Multi Angled Abutmentis intended for use with adental implant to providesupport for prostheticrestorations such asbridges, or overdentures. | Cement Abutment isintended for use with adental implant to providesupport for prostheticrestorations such ascrowns, bridges, oroverdentures. |
| AbutmentAngle(°) | 17, 30 | 17, 30 | 0 |
| platform(Ø) | 4.9 | 4.8 | - |
| connection | External Hex-connectedCompatible with USIISA Fixture | Internal Hex-connectedCompatible with TSII SAFixture | External Hex-connectedCompatible with USIISA Fixture |
QS-QI-505-3(Rev.0)
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Image /page/8/Picture/1 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with the letters slightly overlapping each other. Below "OSSTEM" is the word "IMPLANT" in gray. To the right of the word "OSSTEM" is a small orange circle.
STEM Implant Co., Ltd
Bansong-ro 513beon-gil. Haeundae-gu. Busan, Republic of Korea 1: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
| Connection | US Multi Angled Abutment has the same material, indication for use, function andsimilar design as the Multi Angled Abutment (K123755) except connectionstructure.But connection structure is exactly same with Cement Abutment, K073247In accordance with difference of connection and shape, we conducted fatigue testto confirm proposed device strength |
|---|---|
| ------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
5. Indication for use :
The US SA 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 such as bridges, or overdenture.
6. Review :
The US SA Implant System has same material and indication for use and similar design and technological characteristics as the predicate device.
7. Summary of nonclinical testing
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence:
Fatigue testing was conducted with subject devices according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment".
Gamma Sterilization Validation was performed with Fixture System according to ISO 11137-1, ISO 11137-2 and ISO 11137-3. Steam sterilization validation was provided according to ISO 17665-1 and ISO 17665-2.
Subject devices are made of the same materials, manufacturing process, chemical composition, and body contact with the predicate devices, the TS Fixture System, OSSTEM Implant Co., Ltd., K121995 and Multi Angled Abutment, OSSTEM Implant Co., Ltd., K123755
therefore US SA Implant System is substantially equivalent to the predicate devices in biocompatibility, surface coating characterization
8. 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 US SA Implant System is substantially equivalent to the predicate devices as described herein.
- Conclusions
§ 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.