TSIII BA Fixture
Device Facts
| Record ID | K163088 |
|---|---|
| Device Name | TSIII BA Fixture |
| Applicant | Osstem Implant Co., Ltd. |
| Product Code | DZE · Dental |
| Decision Date | Apr 21, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
TSIII BA Fixture 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.
Device Story
TSIII BA Fixture is an endosseous dental implant; surgically placed in maxilla or mandible bone to support dental restorations. Device features single threads, internal hex connection, and tapered body. Surface treatment involves sandblasting, acid etching, calcium phosphate coating, and hydrophilic coating (glucose/NaCl). Supplied sterile via radiation. Used by dentists/oral surgeons in clinical settings. Provides stable foundation for prosthetic abutments and restorations; facilitates oral rehabilitation in edentulous patients.
Clinical Evidence
No clinical data provided. Substantial equivalence supported by non-clinical bench testing, including biocompatibility, sterilization validation (ISO 11137-2:2006), and surface treatment characterization identical to predicate.
Technological Characteristics
Material: Pure Titanium Grade 4 (ASTM F67). Design: Tapered body, single thread, internal hex connection. Surface: Sandblasted, acid-etched, calcium phosphate/hydrophilic coating. Sterilization: Radiation (25 kGy). Connectivity: Mechanical interface for dental abutments.
Indications for Use
Indicated for partially or fully edentulous patients (mandibles and maxillae) requiring single or multiple-unit restorations (cemented, screw-retained, or overdenture) or fixed bridgework support. Intended for delayed loading.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- ETIII Bio-A Fixture System (K151626)
Reference Devices
- TS Fixture System (K121995)
Submission Summary (Full Text)
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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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, layered on top of each other, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 21, 2017
Osstem Implant Co., Ltd. c/o Mr. David Kim Manager Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills. Pennsylvania 19030
Re: K163088
Trade/Device Name: TSIII BA Fixture Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: March 21, 2017 Received: March 21, 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 (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.
# 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 in bold, black font, with the word "OSSTEM" in a stylized orange font to the left. Below the company name is the address: 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea. The image also includes the telephone number: +82 51 850-2500, fax number: +82 51 850-4341 and website: www.osstem.com.
## Indications for Use Statement
## Indications for Use
510(k) Number ______________________________________________________________________________________________________________________________________________________________________________
Device Name: TSIII BA Fixture
Indication for Use:
TSIII BA Fixture 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.
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)
QS-QI-505-2(Rev.0)
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Image /page/3/Picture/1 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. The logo is simple and modern.
'EM Implant Co., Ltd
Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
### 510(k) Summary
Date: April 18, 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 |
- 2. Device:
Trade or (Proprietary) Name : TSIII BA Fixture Common or usual name : Dental Implant Classification Name : Endosseous Dental Implant Regulation Number : 21CFR872.3640 Device Classification: Class || Product Code: DZE
- 3. Predicate Device:
Primary Predicate K151626, ETIII Bio-A Fixture System, HIOSSEN Inc.
Reference predicate K121995, TS Fixture System, OSSTEM Implant Co., Ltd.
- 4. Device Description:
(1) Design Features (Same with ETIII Bio-SA Fixture System (K151626)) TSIII BA Fixture has features of single threads, internal hex connection, taper body, and BA surface treatment.
(2) Raw material used (Same with ETIII Bio-SA Fixture System (K151626)) TSIII BA Fixture System is permanent dental implant made with Pure Titanium Grade 4 (ASTMF67-06).
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 gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray.
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
(3) BA Surface treatment (Same with ETIII Bio-SA Fixture System (K151626)) The proposed device is sandblasted, acid etched, coated with calcium phosphate by immersing and then finally coated with hydrophilic materials (glucose and NaCl with saline concentrations). Surface treatment of TSIII BA Fixture is exactly same with ETIII Bio-SA Fixture System (K151626) in Surface treatment method and material, etc.
The proposed device, TSIII BA Fixture System is substantially equivalent to commercially and legally available medical devices (ETIII Bio-SA Fixture System (K151626)) based on the intended use, the technology used, the claims, the material used and performance characteristics.
| Device<br>Description | Intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is supplied sterile. | |
|-----------------------|-------------------------------------------------------------------------------------------------------------|------------------|
| Material | Pure Titanium (ASTM F 67) | |
| Surface | BA surface treatment | |
| | Diameter (mm) | Length (mm) |
| | 3.77 | 8.5 |
| | 3.75 | 10.0, 11.5, 13.0 |
| | 4.25 | 7.0, 8.5 |
| | 4.0 | 10.0, 11.5, 13.0 |
| Dimension | 4.65 | 7.0 |
| | 4.63 | 8.5 |
| | 4.6 | 10.0, 11.5, 13.0 |
| | 5.1 | 6.2, 7.0 |
| | 5.08 | 8.5 |
| | 5.05 | 10.0, 11.5, 13.0 |
- TSIII BA Fixture
#### - Substantial Equivalence Matrix
| | | Primary Predicate | Reference predicate | Summary of<br>difference |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| | TSIII BA Fixture | ETIII Bio-SA<br>Fixture | TS Fixture System<br>(TSIII SA Fixture &<br>TSIII SA Ultra Wide<br>Fixture) | |
| 510(K) No. | New Device | K151626 | K121995 | - |
| Manufacturer | OSSTEM Implant<br>Co., Ltd. | HIOSSEN Inc. | OSSTEM Implant<br>Co., Ltd. | Same with<br>Reference<br>predicate |
| Indication for<br>use | TSIII BA Fixture is<br>indicated for use in<br>partially or fully<br>edentulous<br>mandibles and<br>maxillae, in support<br>of single or | The ETIII Bio-SA<br>Fixture System is<br>indicated for use in<br>partially or fully<br>edentulous<br>mandibles and<br>maxillae. in support | | Indication for<br>use of subject<br>device is<br>almost same<br>with Predicate<br>devices |
| | multiple-units<br>restorations<br>including; cemented<br>retained, screw<br>retained, or<br>overdenture<br>restorations, and<br>final or temporary<br>abutment support for<br>fixed bridgework. It<br>is intended for<br>delayed loading. | of single or multiple<br>-unit restorations<br>including ;cemented<br>retained, screw<br>retained, or over-<br>denture restorations,<br>and terminal or<br>intermediate abut-<br>ment support for<br>fixed bridgework.<br>The ETIII Bio-SA<br>Fixture System is<br>for single and two<br>stage surgical pro-<br>cedures. It is<br>intended for delayed<br>loading. | The TS Fixture<br>System is indicated<br>for use in partially or<br>fully edentulous<br>mandibles and<br>maxillae, in support<br>of single or multiple-<br>unit restorations<br>including; cemented<br>retained, screw<br>retained, or<br>overdenture<br>restorations, and<br>final or temporary<br>abutment support for<br>fixed bridgework. It<br>is intended for<br>delayed loading. TS<br>Fixture System is<br>compatible with<br>abutment in the<br>ET/SS Implant<br>System. | |
| Surgery type | One or two stage<br>Surgery | One or two stage<br>Surgery | One or two stage<br>Surgery | Same |
| Structure | -Single Thread<br>-Taper body Type<br>-Self tapping<br>-Submerged fixture | -Single Thread<br>-Taper body Type<br>-Self tapping<br>-Submerged fixture | -Single Thread<br>-Taper body Type<br>-Self tapping<br>-Submerged fixture | Same |
| Body Diameter<br>(D) (mm) | 3.75, 3.77, 4.2, 4.25,<br>4.6, 4.63, 4.65, 5.05,<br>5.08, 5.1 | 3.75, 3.77, 4.25, 4.6<br>4.65, 4.63, 5.05,<br>5.08, 5.1 | 3.75, 3.77, 4.2, 4.25,<br>4.6, 4.63, 4.65, 5.05,<br>5.08, 5.1, 6, 5.95,<br>5.92, 6.8 | Same with<br>Reference<br>predicate |
| Length (mm) | 7.0, 8.0, 8.5, 9.5,<br>10.0, 11.0, 11.5,<br>12.5, 13.0 | 7.2 , 8.7, 10.2, 11.7,<br>13.2, 15.2 | 7.0, 8.0, 8.5, 9.5,<br>10.0, 11.0, 11.5,<br>12.5, 13.0, 15.0, | |
| Material of<br>Fixture | Pure Titanium Grade<br>4 (ASTM F67) | Pure Titanium Grade<br>4 (ASTM F67) | Pure Titanium Grade<br>4 (ASTM F67) | Same |
| Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com | | | | |
| Surface | TSIII BA Fixture is<br>sandblasted, acid<br>etched, coated with<br>calcium phosphate<br>by immersing and<br>then finally coated | ETIII Bio-SA<br>Fixture System is<br>sandblasted, acid<br>etched, coated with<br>calcium phosphate<br>by immersing and | SA (Sandblasting and<br>Acid etching, treated.) | Same with<br>Primary<br>Predicate |
QS-QI-505-3(Rev.0)
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K163088
Image /page/5/Picture/1 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with a small degree symbol next to it. Below that, the word "IMPLANT" is written in gray.
**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
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Image /page/6/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 orange circle in the upper right corner of the logo.
## EM Implant Co.
Haeundae-gu, Busan, Republic of Korea Bansong-ro 513beon
K163088
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Image /page/7/Picture/0 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, sans-serif font. To the right of the word "OSSTEM" is a small, raised circle.
## EM Implant Co., L
Haeundae-on Busan Republic of +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
| | with hydrophilic<br>materials (glucose<br>and NaCl with saline<br>concentrations) | then finally coated<br>with hydrophilic<br>materials (glucose<br>and NaCl with saline<br>concentrations) | | |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|-------------------|-----------------------------------|
| Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile | Same |
| Shelf life | 5years | 5years | 8years | Same with<br>Primary<br>Predicate |
| S E | S.E<br>Subject devise, TSIII BA Fixture is almost same with Primary Predicate, ETIII Bio-<br>SA Fixture in shape, dimension, intended for use and they have same Technological<br>Characteristics, principles of operation, same connection structure and material And<br>subject device and Primary predicate device.<br>Although manufacturer of Primary predicate is different from subject device, all<br>subject device and predicate devices are designed by OSSTEM R&D Center.<br>Therefore, TSIII BA Fixture is substantially equivalent to the predicate devices. | | | |
#### 5. Indication for use
TSIII BA Fixture 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.
#### 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 TSIII BA Fixture was previously conducted. As the material of construction and manufacturing processes are the same as the predicate device, ETIII Bio-SA Fixture (K151626) exactly.
Therefore, no additional testing is required to support the biological safety of the subject devices.
#### Sterilization validation
The sterilization validation of the dental implant (TSIII BA Fixture) was carried out according to the protocol relating to the requirements described in ISO 11137-2:2006. The substantiated 25 kGy sterilization dose for 106 SAL is accepted as the bioburden of 1.000 cfu/unit & the verification test performed by the verification dose is met the acceptance criteria. In accordance with ISO11137 VDmax 25, therefore allows use of minimum dose 25 kGy as a routine sterilizing dose.
The results of the evaluation on the material stability show that the packaging materials was
QS-QI-505-3(Rev.0)
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Image /page/8/Picture/1 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is written in orange, with a small circle above the "M". Below the word "OSSTEM" is the word "IMPLANT" written in gray. The logo is simple and modern.
TEM Implant Co., Lt
Haeundae-gu. Busan. Republic of Korea +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
inherently less affected by radiation in the maximum acceptable dose 40 kGy.
The packaging is the same as the predicate. Validation for the packaging was conducted on the TS Fixture System (K121995) according to ASTM F1980 by accelerated aging and validated a 5 year shelf life. No additional shelf-life validation was performed on the subject device.
#### LAL Testing
LAL testing of the subject device and information per the FDA Guidance Document entitled, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," issued January 21, 2016.
#### Surface treatment characterization testing
TSIII BA Fixture has BA (sandblasted, acid etched, coated with calcium phosphate by immersing and then finally coated with hydrophilic materials (glucose and NaCl with saline concentrations)) surface treatment that is exactly same with the predicate devices, ETIII Bio-SA Fixture (K151626). There has been no change to the manufacturing or surface treatment processes since then; therefore, additional characterization testing is not required.
#### Fatigue test
TSIII BA Fixture is exactly same with predicate, TS Fixture System, K121995 in material, shape and dimension except surface treatment. Therefore additional Fatigue testing is not required.
- 7. 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 Osstem Implant Co., Ltd. concludes that the TSIII BA Fixture is substantially equivalent to the predicate devices as described herein.
