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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the OssBuilder System, a dental device intended to stabilize and support bone grafts. It does not describe a clinical study in the traditional sense, but rather a set of non-clinical performance tests to demonstrate substantial equivalence to predicate devices. Therefore, many of the requested categories for clinical studies will not be applicable.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific quantitative thresholds. Instead, it states that the mechanical properties of the OssBuilder System were found to be "substantially equivalent" to predicate devices. The acceptance criteria are implied to be that the proposed device performs at least as well as the predicate device in relevant mechanical tests and maintains biocompatibility and sterility.

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance
Biocompatibility	Materials (Titanium, Ti-6Al-4V) must be biologically compatible for dental use, consistent with predicate devices.	"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..."
Sterilization Validation	Sterility must be confirmed according to ISO 11137, with worst-case testing among subject devices.	"For the sterilization validation, it was performed accordance with worst-case chosen among subject devices and following ISO 11137." Acknowledged as performed.
Shelf-life	Packaging materials and device integrity must be validated for the stated shelf-life (8 years for components).	"For the shelf-life of subject devices, we considered their validation of packaging materials by leveraging the data that of our prior submissions." New shelf life of 8 years for OssBuilder, Healing Cap, Cover Cap, and OB Anchor compared to 5 years for predicates, supported by leveraging prior submission data.
Mechanical Properties	Tensile Strength, Yield Strength, and Elongation of components must be comparable to, or better than, predicate devices.	"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." The document explicitly states that mechanical properties were found "substantially equivalent" to predicate devices, and that the differences in design (e.g., shape, height, connection structure) or material (for some Cover Cap models) do not affect function or indication for use.

2. Sample size used for the test set and the data provenance

For the non-clinical performance testing (biocompatibility, sterilization, shelf-life, mechanical properties), specific sample sizes are not explicitly mentioned in the provided text. The data provenance is also not detailed beyond stating they are "non-clinical testing data" and "bench tests." It can be inferred that these tests were conducted by the manufacturer, Osstem Implant Co., Ltd., likely in their Korean facilities or outsourced to testing laboratories. The nature of these tests (e.g., material testing, sterilization validation) means they are not retrospective or prospective studies in the sense of clinical trials, but rather laboratory-based evaluations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as the document describes non-clinical performance testing (material properties, sterilization, etc.), not a study requiring expert readers or ground truth establishment for diagnostic accuracy.

4. Adjudication method for the test set

This question is not applicable for the same reasons as #3.

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

There is no mention of an MRMC comparative effectiveness study, human readers, or AI assistance in this document. The OssBuilder System is a physical dental device, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the OssBuilder System is a physical dental device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests described:

Biocompatibility: The ground truth is based on the well-established biocompatibility of titanium and Ti-6Al-4V alloys, which are widely used in medical implants, and the equivalence to predicate devices made of the same materials.
Sterilization Validation: The ground truth for sterility is established by industry standards (ISO 11137).
Shelf-life: The ground truth for shelf-life is established by internal testing and leveraging data from prior submissions for packaging materials durability.
Mechanical Properties: The ground truth for mechanical properties (Tensile Strength, Yield Strength, Elongation) is derived from standardized material testing methods and comparison to the known properties of the predicate devices.

8. The sample size for the training set

This question is not applicable as there is no "training set" in the context of a physical medical device's non-clinical performance testing.

9. How the ground truth for the training set was established

This question is not applicable for the same reasons as #8.

Summary

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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);

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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

1. Company and Correspondent making the submission

- Submitter's Name	: OSSTEM IMPLANT Co., Ltd.
- Address	: 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan612-070, 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

1. 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.
- Primary Predicate -SMARTbuilder System, OSSTEM IMPLANT Co., Ltd. (K120951)
- -Reference Devices SMARTBUILDER SYSTEM (SB1) (K130840) SB Anchor, OSSTEM Implant Co., Ltd. (K140600)

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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

The OssBuilder System is not indicated for permanent implantation.

Item	Content
OssBuilder	Description	OssBuilder is 3D pre-formed titanium made non-resorbablemembrane that helps bone augmentation by performing bone grafton the intraoral site with autogenous bone defect.
	Material	Pure Titanium Grade 4 (ASTM F67)
	Dimension(mm)	OB2 ProximalBuccal widthBuccal lengthBuccal distance
		OB3 Buccal widthBuccal lengthLingual lengthBuccal distanceLingual 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 fixOssBuilder during osseointegration and prevents intrusion of foreignmaterial.
	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 fixOssBuilder during osseointegration and prevents intrusion of foreignmaterial.
	Material	Ti-6Al-4V (ASTMF 136)
	Dimension(mm)	D (Ø)
		H

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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.

1. Substantial Equivalence Matrixes

Change on the 'name' of the predicated devices
	Proposed	Predicated	Remark
Device Name	Oss builer OB2	SMARTbuilder SB2K120951	No othermodificationshappened exceptfor the name ofthe device.
	Healing Cap	Healing AbutmentK120951
	OB Anchor	SB AnchorK140600

	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 ametal device intended foruse with a dental implantto stabilize and support ofbone graft in dento-alvolarbony defect sites.	SMARTbuilder is a metaldevice intended for usewith a dental implant tostabilize and support ofbone 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

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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 sameindication for use and sterilization method; and is made by samemanufacturer compared to the predicated SMARTbuilder (SB2)(K120951).DifferencesApplication site is different between the proposed OssBuider (OB3) and thepredicated, 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 materialand has same function and indication for use compared to that of thepredicated; therefore, the proposed OssBuilder (OB3) is substantiallyequivalent to the predicated SMARTbuilder (SB2) (K120951) basedon 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 ametal device intended foruse with a detal implant tostabilize and support ofbone graft in dento-alveolar bony defect sites.	SMARTbuilder is a metaldevice intended for usewith a dental implant tostabilize and support ofbone 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 rangeof the predicateddevice.
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.	SimilaritiesThe proposed Healing Cap is made of same material and has sameindication for use and sterilization method; and is made by samemanufacturer compared to the predicated Healing Abutment (K120951).

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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.
DifferencesThe proposed Healing Cap is used with internal type of anchor while thepredicated Healing Abutment is used with external type of anchor. That iswhy the proposed device has longer height.
: While the proposed Healing Cap has different connection structurebecause it is compatible with different type of anchor than the predicated,its function and indication for use is same; therefore, the proposed HealingCap 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 ametal device intended foruse with a detal implant tostabilize and support ofbone graft in dento-alveolar bony defect sites.	SMARTbuilder is a metaldevice intended for usewith a dental implant tostabilize and support ofbone 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.	SimilaritiesThe proposed Cover Cap has same identifier, design, indication for use,diameter, and sterilization method; and is made by same manufacturercompared to the predicated Cover Cap (K120951).DifferencesThe material for the proposed Cover Cap is Ti-6Al-4V while the predicatedis 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 differentfrom the predicated, its design function, and indication for use is same;therefore, the proposed Cover Cap is substantially equivalent to the

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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 biocompatibilityevaluations 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 ametal device intended foruse with a detal implant tostabilize and support ofbone graft in dento-alveolar bony defect sites.	SMARTbuilder is a metaldevice intended for usewith a dental implant tostabilize and support ofbone 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.	SimilaritiesThe proposed additional shape of Cover Cap has same indication for use,diameter, and sterilization method; and is made by same manufacturercompared to the predicated Cover Cap (K120951).DifferencesThe proposed Cover Cap is made of Ti-6Al-4V while the predicated ismade of Ti Gr. 4. The proposed Cover Cap is used with internal type ofanchor 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 hasdifferent connection structure because it is compatible with different type ofanchor than the predicated, its function and indication for use is same;therefore, the proposed Cover Cap is substantially equivalent to thepredicated Cover Cap (K120951) based on the results of thebiocompatibility evaluations and mechanical properties testing.

	OB Anchor	SB Anchor	Remark
510(k) No.	Proposed	Predicated (K140600)	-

IDD

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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 forUse	OssBuilder Systemis a metaldevice intended for use with a detalimplant to stabilize and support ofbone graft in dento-alveolar bonydefect sites.	SMARTbuilder is ametal device intendedfor use with a dentalimplant to stabilize andsupport of bone graft indento-alveolar bonydefect sites.	Identical
Material	Ti-6Al-4V(ASTM F136)	Ti-6Al-4V(ASTM F136)	Identical
Diameter(mm)	3.1~5.0	3.3~5.1	Within therange of thepredicateddevice.
Height (mm)	4.65~9.5	7.0~15	Different
Sterilization	Gamma Sterilization	Gamma Sterilization	Identical
Shelf Life	8 years	8 years	Identical
S.E.	SimilaritiesThe proposed OB Anchor is made of same material, has same indication for useand sterilization method; and is made by same manufacturer compared to thepredicated SB Anchor (K140600). Also, its diameter is within the range of thatof the predicated device.DifferencesThe proposed device is internal type of anchor while the predicated device isexternal type of anchor. That is why the height of the proposed anchor is shorterthan that of the predicated anchor.... The design of the proposed OB Anchor is different because it is internal typeof anchor while the predicated is external type of anchor, but it is made withsame material and has same function and indication for use; therefore, theproposed 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.

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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.

1. Summary of Non-Clinical Performance Testing
  Non-clinical testing data are submitted, referenced, or relied upon to demonstrate substantial equivalence.

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.
1. 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.

Regulation Number and Section

§ 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.