(235 days)
No
The summary describes a purely mechanical device made of metal for stabilizing bone grafts. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No
The device is intended to stabilize and support bone graft, which is an ancillary function to the bone graft itself, not a direct therapeutic action on the patient's condition.
No
This device is a medical implant intended to stabilize and support bone grafts, not to diagnose a medical condition.
No
The device description explicitly states it is a "metal device" and lists physical components (OssBuilder, Healing Cap, Cover Cap, OB Anchor). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "stabilize and support of bone graft in dento-alveolar bony defect sites" using a metal device. This is a surgical/implantable device used directly on the patient's body.
- Device Description: The description confirms it's a "metal device" consisting of components like OssBuilder, Healing Cap, Cover Cap, and OB Anchor, intended for use with a dental implant. This further reinforces its nature as a physical device used in a surgical context.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) to support bone grafting.
N/A
Intended Use / Indications for Use
OssBuilder System is a metal device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.
Product codes (comma separated list FDA assigned to the subject device)
JEY, NHA
Device Description
OssBuilder System is a metal device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites. It is consisted of OssBuilder, Healing Cap, Cover Cap, and OB Anchor.
The OssBuilder System is not indicated for permanent implantation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dento-alveolar bony defect sites
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing data are submitted, referenced, or relied upon to demonstrate substantial equivalence.
Biocompatibility evaluation for OssBuilder System is not considered because the materials used for manufacturing OssBuilder System are titanium and titanium alloy which have been generally and widely used as a dental material such as implant for a long time. OssBuilder System is made of same material, chemical composition, and body contact with the predicated devices, SMARTbuilder System, K120951; SMARTbuilder System (SB1), K130840; and SB Anchor, K140600.
All subject devices in OssBuilder System are delivered in sterile. Therefore, the shelf-life and sterilization was considered. For the sterilization validation, it was performed accordance with worst-case chosen among subject devices and following ISO 11137. For the shelf-life of subject devices, we considered their validation of packaging materials by leveraging the data that of our prior submissions.
Bench tests evaluated for OssBuilder System included Tensile Strength, Yield Strength, and Elongation. Mechanical properties from bench tests of OssBuilder System found substantially equivalent to the predicate device.
No clinical studies are submitted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 26, 2018
Osstem Implant Co., Ltd. David Kim Manager Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030
Re: K172354
Trade/Device Name: OssBuilder System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY, NHA Dated: February 20, 2018 Received: February 20, 2018
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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/0 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 orange to the left. Below the company name is the address: 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea, as well as the telephone number: +82 51 850-2500, fax number: +82 51 850-4341, and website: www.osstem.com.
510(k) Number: K172354
Device Name: OssBuilder System
Indication for Use:
OssBuilder System is a metal device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.
Image /page/2/Picture/5 description: The image contains a square with the letter 'X' inside. The 'X' is centered within the square and appears to be in a simple, sans-serif font. The square is a solid black outline with a white fill, providing a clear contrast for the black 'X'. The image is simple and straightforward, focusing on the single letter within the geometric shape.
Prescription Use (21 CFR 801 Subpart D)
Over-The Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/0 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 telephone number is +82 51 850-2500, the fax number is +82 51 850-4341, and the website address is www.osstem.com.
510(k) Summary
Date: March 24, 2018
-
- Company and Correspondent making the submission
| - Submitter's Name | : OSSTEM IMPLANT Co., Ltd. |
|---|---|
| - Address | : 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan |
| 612-070, Republic of Korea | |
| - Contact | : Ms. Jungmin Yoo |
| - Phone | : +82-51-850-2575 |
| - Correspondent's Name | : HIOSSEN Inc. |
| - Address | : 85 Ben Fairless Dr. Fairless Hills, PA 19030 |
| - Contact | : Mr. David Kim |
| - Phone | : 267-759-7031 |
-
- Device
| Trade or (Proprietary) Name | : OssBuilder System |
|---|---|
| Classification Name | : Bone Plate |
| Regulation Number | : 21CFR872.4760 |
| Devce Classification | : Class II |
| Classification Product Code | : JEY |
| Subsequent Product Code | : NHA |
- Predicate Device 3.
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Image /page/4/Picture/0 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" also appearing in orange and gray on the left side of the image. The contact information includes the company's address, phone number, fax number, and website address. 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 address is www.osstem.com.
4. Description
OssBuilder System is a metal device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites. It is consisted of OssBuilder, Healing Cap, Cover Cap, and OB Anchor.
The OssBuilder System is not indicated for permanent implantation.
| Item | Content | |
|---|---|---|
| OssBuilder | Description | OssBuilder is 3D pre-formed titanium made non-resorbable |
| membrane that helps bone augmentation by performing bone graft | ||
| on the intraoral site with autogenous bone defect. | ||
| Material | Pure Titanium Grade 4 (ASTM F67) | |
| Dimension | ||
| (mm) | OB2 Proximal | |
| Buccal width | ||
| Buccal length | ||
| Buccal distance | ||
| OB3 Buccal width | ||
| Buccal length | ||
| Lingual length | ||
| Buccal distance | ||
| Lingual distance | ||
| OB Anchor | ||
| Material | Ti-6Al-4V (ASTM F136) | |
| Dimension | ||
| (mm) | D (Ø) | |
| L | ||
| Healing Cap | Description | Healing Cap is used by connecting with the OB Anchor to fix |
| OssBuilder during osseointegration and prevents intrusion of foreign | ||
| material. | ||
| Material | Pure Titanium Grade 4 (ASTM F67) | |
| Dimension | ||
| (mm) | D (Ø) | |
| H | ||
| Cover Cap | Description | Cover Cap is used by connecting with the OB Anchor to fix |
| OssBuilder during osseointegration and prevents intrusion of foreign | ||
| material. | ||
| Material | Ti-6Al-4V (ASTMF 136) | |
| Dimension | ||
| (mm) | D (Ø) | |
| H |
5
Image /page/5/Picture/0 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The logo includes the company name in a bold, sans-serif font, with the word "OSSTEM" in a larger size. Below the company name is the address: 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea, as well as the telephone number: +82 51 850-2500, fax number: +82 51 850-4341, and website: www.osstem.com.
The OssBuilder System is compatible with OSSTEM Implant System, K161604; US SA Implant System, K161103; and NT/IT System, K081078.
-
- Substantial Equivalence Matrixes
| Change on the 'name' of the predicated devices | |||
|---|---|---|---|
| Proposed | Predicated | Remark | |
| Device Name | Oss builer OB2 | SMARTbuilder SB2 | |
| K120951 | No other | ||
| modifications | |||
| happened except | |||
| for the name of | |||
| the device. | |||
| Healing Cap | Healing Abutment | ||
| K120951 | |||
| OB Anchor | SB Anchor | ||
| K140600 |
| Oss Builder (OB3) | SMARTbuilder (SB2) | Remark | |
|---|---|---|---|
| 510(k) No. | Proposed | K120951 | - |
| Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Identical |
| Design | Image: Oss Builder Design | Image: SMARTbuilder Design | Different |
| Indication for Use | Oss Builder Systemis a | ||
| metal device intended for | |||
| use with a dental implant | |||
| to stabilize and support of | |||
| bone graft in dento-alvolar | |||
| bony defect sites. | SMARTbuilder is a metal | ||
| device intended for use | |||
| with a dental implant to | |||
| stabilize and support of | |||
| bone graft in dento- | |||
| alveolar bony defect sites. | Identical | ||
| Material | Pure Titanium Grade 2 | ||
| (ASTM F67) | Pure Titanium Grade 2 | ||
| (ASTM F67) | Identical | ||
| Width (D, mm) | 10, 20 | 8, 9, 10, 12 | Different |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Identical |
| Shelf Life | 8 years | 5 years | Different |
| S.E | Similarities |
6
Image /page/6/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with the word "IMPLANT" written in gray below it. There is a small orange circle with a white number 6 in the upper right corner of the logo.
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
| The proposed Os sBuilder (OB3) is made of same material and has same
indication for use and sterilization method; and is made by same
manufacturer compared to the predicated SMARTbuilder (SB2)
(K120951).
Differences
Application site is different between the proposed OssBuider (OB3) and the
predicated, and it causes shape differences as a result.
... While there are shape differences between the proposed Os sBuilder
(OB3) and the predicated, the proposed device is made with same material
and has same function and indication for use compared to that of the
predicated; therefore, the proposed OssBuilder (OB3) is substantially
equivalent to the predicated SMARTbuilder (SB2) (K120951) based
| on the results of the mechanical properties testing. | |||
|---|---|---|---|
| Healing Cap | Healing Abutment | Remark | |
| 510(k) No. | Proposed | Predicated (K120951) | |
| Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Identical |
| Design | Image: Healing Cap | Image: Healing Abutment | Different |
| Indication for Use | Oss Builder System is a | ||
| metal device intended for | |||
| use with a detal implant to | |||
| stabilize and support of | |||
| bone graft in dento- | |||
| alveolar bony defect sites. | SMARTbuilder is a metal | ||
| device intended for use | |||
| with a dental implant to | |||
| stabilize and support of | |||
| bone graft in dento- | |||
| alveolar bony defect sites. | Identical | ||
| Material | Pure Titanium Grade 4 | ||
| (ASTM F67) | Pure Titanium Grade 4 | ||
| (ASTM F67) | Identical | ||
| Diameter (mm) | 4.0-5.0 | 4.0-7.0 | Within the range |
| of the predicated | |||
| device. | |||
| Height (mm) | 7.0-8.0 | 3.35-4.22 | Different |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Identical |
| Shelf Life | 8 years | 5 years | Different |
| S.E. | Similarities | ||
| The proposed Healing Cap is made of same material and has same | |||
| indication for use and sterilization method; and is made by same | |||
| manufacturer compared to the predicated Healing Abutment (K120951). |
7
Image /page/7/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in orange, with a small superscript "6" next to the "M". Below "OSSTEM" is the word "IMPLANT" 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
| Also, its diameter is within the range of that of the predicated device. |
|---|
| Differences |
| The proposed Healing Cap is used with internal type of anchor while the |
| predicated Healing Abutment is used with external type of anchor. That is |
| why the proposed device has longer height. |
| : While the proposed Healing Cap has different connection structure |
| because it is compatible with different type of anchor than the predicated, |
| its function and indication for use is same; therefore, the proposed Healing |
| Cap is substantially equivalent to the predicated Healing Abutment |
| (K120951) based on the results of the mechanical properties tests. |
| Cover Cap | Cover Cap | Remark | |
|---|---|---|---|
| 510(k) No. | Proposed | Predicated (K120951) | |
| Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Identical |
| Identifier | SMCC415 | SMCC415 | Identical |
| Design | Image: Cover Cap Design | Image: Cover Cap Design | Identical |
| Indication for Use | Oss Builder Systemis a | ||
| metal device intended for | |||
| use with a detal implant to | |||
| stabilize and support of | |||
| bone graft in dento- | |||
| alveolar bony defect sites. | SMARTbuilder is a metal | ||
| device intended for use | |||
| with a dental implant to | |||
| stabilize and support of | |||
| bone graft in dento- | |||
| alveolar bony defect sites. | Identical | ||
| Material | Ti-6Al-4V | ||
| (ASTM F 136) | Pure Titanium Grade 4 | ||
| (ASTM F67) | Different | ||
| Diameter (mm) | 4.0 | 4.0 | Identical |
| Height (mm) | 1.73 | 1.52 | Different |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Identical |
| Shelf Life | 8 years | 5 years | Different |
| S.E. | Similarities | ||
| The proposed Cover Cap has same identifier, design, indication for use, | |||
| diameter, and sterilization method; and is made by same manufacturer | |||
| compared to the predicated Cover Cap (K120951). | |||
| Differences | |||
| The material for the proposed Cover Cap is Ti-6Al-4V while the predicated | |||
| is Ti Gr.4; and its height is different than that of the predicated. | |||
| While the material and the height of the proposed Cover Cap is different | |||
| from the predicated, its design function, and indication for use is same; | |||
| therefore, the proposed Cover Cap is substantially equivalent to the |
8
Image /page/8/Picture/0 description: The image contains the logo for Osstem Implant. The logo is comprised of the word "OSSTEM" in orange, with the word "IMPLANT" in gray underneath. The logo is simple and modern, and the colors are bright and eye-catching.
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
| predicated Cover Cap (K120951) based on the results of the biocompatibility
| evaluations and mechanical properties testing. | |||
|---|---|---|---|
| Cover Cap | Cover Cap | Remark | |
| 510(k) No. | Proposed | Predicated (K120951) | - |
| Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Identical |
| Design | Image: Proposed Cover Cap | Image: Predicated Cover Cap | Different |
| Indication for Use | Oss Builder Systemis a | ||
| metal device intended for | |||
| use with a detal implant to | |||
| stabilize and support of | |||
| bone graft in dento- | |||
| alveolar bony defect sites. | SMARTbuilder is a metal | ||
| device intended for use | |||
| with a dental implant to | |||
| stabilize and support of | |||
| bone graft in dento- | |||
| alveolar bony defect sites. | Identical | ||
| Material | Ti-6Al-4V | ||
| (ASTM F 136) | Pure Titanium Grade 4 | ||
| (ASTM F67) | Different | ||
| Diameter (mm) | 4.0 | 4.0 | Identical |
| Height (mm) | 4.3 | 1.52 | Different |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Identical |
| Shelf Life | 8 years | 5 years | Different |
| S.E. | Similarities | ||
| The proposed additional shape of Cover Cap has same indication for use, | |||
| diameter, and sterilization method; and is made by same manufacturer | |||
| compared to the predicated Cover Cap (K120951). |
Differences
The proposed Cover Cap is made of Ti-6Al-4V while the predicated is
made of Ti Gr. 4. The proposed Cover Cap is used with internal type of
anchor while the predicated Cover Cap is used with external type of anchor.
That is why the proposed device has longer height.
... While the proposed Cover Cap is made with different material and has
different connection structure because it is compatible with different type of
anchor than the predicated, its function and indication for use is same;
therefore, the proposed Cover Cap is substantially equivalent to the
predicated Cover Cap (K120951) based on the results of the
biocompatibility evaluations and mechanical properties testing. | | |
| OB Anchor | SB Anchor | Remark | |
|---|---|---|---|
| 510(k) No. | Proposed | Predicated (K140600) | - |
IDD
9
Image /page/9/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with the superscript symbol of a degree symbol. Below the word "OSSTEM" is the word "IMPLANT" 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
| Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co.,
Ltd. | Identical |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Design | Image: [Osstem Implant Co., Ltd. Design] | Image: [Osstem Implant Co., Ltd. Design] | Different |
| Indication for
Use | OssBuilder Systemis a metal
device intended for use with a detal
implant to stabilize and support of
bone graft in dento-alveolar bony
defect sites. | SMARTbuilder is a
metal device intended
for use with a dental
implant to stabilize and
support of bone graft in
dento-alveolar bony
defect sites. | Identical |
| Material | Ti-6Al-4V
(ASTM F136) | Ti-6Al-4V
(ASTM F136) | Identical |
| Diameter
(mm) | 3.15.0 | 3.35.1 | Within the
range of the
predicated
device. |
| Height (mm) | 4.659.5 | 7.015 | Different |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Identical |
| Shelf Life | 8 years | 8 years | Identical |
| S.E. | Similarities
The proposed OB Anchor is made of same material, has same indication for use
and sterilization method; and is made by same manufacturer compared to the
predicated SB Anchor (K140600). Also, its diameter is within the range of that
of the predicated device.
Differences
The proposed device is internal type of anchor while the predicated device is
external type of anchor. That is why the height of the proposed anchor is shorter
than that of the predicated anchor.
... The design of the proposed OB Anchor is different because it is internal type
of anchor while the predicated is external type of anchor, but it is made with
same material and has same function and indication for use; therefore, the
proposed OB Anchor is substantially equivalent to the predicated SB Anchor
(K140600) based on the results of the mechanical properties tests. | | |
6. Indication for Use
OssBuilder System is a metal device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.
10
Image /page/10/Picture/0 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" also appearing in orange next to the company name. Below the company name is the address: 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea, as well as the telephone number: +82 51 850-2500, fax number: +82 51 850-4341, and website: www.osstem.com.
-
- Summary of Non-Clinical Performance Testing
Non-clinical testing data are submitted, referenced, or relied upon to demonstrate substantial equivalence.
- Summary of Non-Clinical Performance Testing
Biocompatibility evaluation
Biocompatibility evaluation for OssBuilder System is not considered because the materials used for manufacturing OssBuilder System are titanium and titanium alloy which have been generally and widely used as a dental material such as implant for a long time. OssBuilder System is made of same material, chemical composition, and body contact with the predicated devices, SMARTbuilder System, K120951; SMARTbuilder System (SB1), K130840; and SB Anchor, K140600.
Sterilization Validation and Shelf-life
All subject devices in OssBuilder System are delivered in sterile. Therefore, the shelf-life and sterilization vas considered. For the sterilization validation, it was performed accordance with worst-case chosen among subject devices and following ISO 11137. For the shelf-life of subject devices, we considered their validation of packaging materials by leveraging the data that of our prior submissions.
Mechanical Properties
Bench tests evaluated for OssBuilder System included Tensile Strength, Yield Strength, and Elongation. Mechanical properties from bench tests of OssBuilder System found substantially equivalent to the predicate device.
-
Summary of Clinical Testing 8.
No clinical studies are submitted. -
- Conclusion
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 OssBuilder System is substantially equivalent to the predicated devices as herein.
- Conclusion