Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical, pre-formed titanium membrane for bone grafting and makes no mention of AI or ML technology.

Therapeutic

Yes.
The device is intended to stabilize and support bone graft in dento-alveolar bony defect sites, which is a therapeutic intervention for tissue repair and regeneration.

Diagnostic

No

This device is a titanium membrane designed to stabilize and support bone grafts. Its function is to aid in the physical repair of bone defects, not to diagnose medical conditions or provide information for diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "metal (Non-resorbable membrane) device" made of "pure titanium metal," indicating it is a physical hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is a "metal (Non-resorbable membrane) device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites." This describes a surgical implant used in vivo (within the body) to support bone regeneration.
Device Description: The description further clarifies it's a "Customized 3D Pre-Formed Titanium Membrane" made of titanium metal, used to stabilize and support bone graft in the oral cavity. This is consistent with an implantable device.
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 samples, 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 as a structural support during a surgical procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SMARTbuilder 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

JEY, NHA

Device Description

Customized 3D Pre-Formed Titanium Membrane. SMARTBuilder is the non-absorbable membrane that is made of titanium metal to stabilize and support of bone graft after bone transplantation at the area having autogenous bone deficiency in the oral cavity. The SMARTbuilder is made of pure titanium metal and supplied sterile. The SMARTbuilder system is used with GS3 System (K091208) of OSSTEM Implant Co., Ltd. and US.SS.GS System (K073247) of OSSTEM Implant Co., Ltd.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

dento-alveolar bony defect sites (oral cavity)

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

No clinical studies are submitted. Biocompatibility evaluation for SMARTbuilder System is not considered because SMARTbuilder System, which is made with titanium alloy, has been generally and widely used as a dental material such as implant for a long time.

Key Metrics

Not Found

Predicate Device(s)

K111761, K090825

Reference Device(s)

K091208, K073247

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

K 120951

ОСТ 3 2012 -

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: August 28, 2012

Company and Correspondent making the submission:

Submitter's Name :
Address :

OSSTEM Implant Co., Ltd.

#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804, Republic of Korea

Contact :

Device :

Trade or (Proprietary) Name : Classification Name :

SMARTbuilder System Bone Plate 21CFR872.4760 Class II JEY, NHA

Mr. Hee Kwon Son

Predicate Device:

The Neo Titanium mesh, CTi-mem, Neobiotech Co., Ltd., K111761 The SQ IS SYSTEM, Neobiotech Co., Ltd., K090825

4. Description:

Customized 3D Pre-Formed Titanium Membrane. SMARTBuilder is the non-absorbable membrane that is made of titanium metal to stabilize and support of bone graft after bone transplantation at the area having autogenous bone deficiency in the oral cavity.

		Dimensions (mm)
Image: BW	Image: BD and BL	BW(Buccal width): 8.0, 10.0
BD(Buccal Distance): 5.5
BL(Buccal Length): 7, 9

QS-QI-505-3(Rev.0)

Letter(8.5 X 11in)

1

Image /page/1/Figure/0 description: The image shows diagrams of dental implant components with associated measurements. The first two components have a buccal width of 9.0 to 12.0, a buccal distance of 5.5, and a buccal length of 7 to 9. Other components have height measurements ranging from 0.5 to 3.0 and diameters from 3.3 to 5.03, while another has a height of 1.52 and a diameter of 4.0.

OSSTEM Implant Co., Ltd

The SMARTbuilder is made of pure titanium metal and supplied sterile.

The SMARTbuilder system is used with GS3 System (K091208) of OSSTEM Implant Co., Ltd. and US.SS.GS System (K073247) of OSSTEM Implant Co., Ltd.

The SMARTbuilder is substantially equivalent in design, function and intended use to the Neo Titanium mesh, CTi-mem (K111761) of Neobiotech Co., Ltd Height, Healing abutment and Cover cap of The SMARTbuilder system are substantially equivalent in design, function and intended use to the SQ IS SYSTEM (K090825) of Neobiotech Co., Ltd

QS-QI-505-3(Rev.0)

Letter(8.5 X 11in)

2

OSSTEM® MPLANT

OSSTEM Implant Co., Ltd. #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea

Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

- Substantial Equivalence Matrix
	SMARTbuilder	Predicate devices
CTi-mem (K111761)
Design	Image: SMARTbuilder design	Image: Cti-mem design
Intended
use	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.	For Stabilization and support bone grafts in
dento-alveolar bony defect sites
Material of
Fixture	Pure Titanium Grade 2 (ASTM F67)	Pure Titanium Grade 2 (ASTM F67)
Width (D)	8, 9, 10, 12	12
Sterilization	Sterilie	Sterilie
Shelf life	5 years
SE	The SMARTbuilder has same material and indication for use and similar design and
technological characteristics as the predicate device, such as the CTi-mem

- Substantial Equivalence Matrix

| | SMARTbuilder System
Healing Abutment | Predicate devices | |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|--|
| | | SQ IS SYSTEM (K090825)
CTi Healing Abutment | |
| Design | Image: SMARTbuilder System Healing Abutment | Image: SQ IS SYSTEM (K090825) CTi Healing Abutment | |
| Intended
use | 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. | For Stabilization and support bone grafts in
dento-alveolar bony defect sites | |
| Material of
Fixture | Pure Titanium Grade 4 (ASTM F67) | Pure Titanium (ASTM F67) | |
| Diameter | 4.07 | 4.0 | |
| Height | 3.354.22 | 3.0, 4.0 | |
| Sterilization | Sterilie | Sterilie | |
| Shelf life | 5years | | |
| SE | The Healing Abutment has same material and indication for use and similar design and
technological characteristics as the predicate device, such as the CTi Healing Abutment | | |

QS-QI-505-3(Rev.0)

Letter(8.5 X 11in)

September 1997 - 1992 - 1992 - 1991 - 1991 - 19

3

OSSTEM® IMPLANT

OSSTEM Implant Co., Ltd.

#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

| | SMARTbuilder System
Height | Predicate devices
SQ IS SYSTEM (K090825)
CTi Spacer | |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|--|
| Design | | | |
| Intended
use | 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. | For Stabilization and support bone grafts in
dento-alveolar bony defect sites | |
| Material
of
Fixture | Titanium alloy Ti 6Al 4V (ASTM F 136) | Pure Titanium (ASTM F67) | |
| Steriliza
tion | Sterilie | Sterilie | |
| Shelf life | 5years | | |
| SE | The Height has same material and indication for use and similar design and
technological characteristics as the predicate device, such as the CTi Spacer | | |

| | SMARTbuilder
Cover Cap | Predicate devices | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|--|
| | Image: SMARTbuilder Cover Cap | SQ IS SYSTEM (K090825)
CTi Cover Cap | |
| Design | Image: SMARTbuilder Cover Cap | Image: CTi Cover Cap | |
| Intended
use | 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. | For Stabilization and support bone grafts in
dento-alveolar bony defect sites | |
| Material
of Fixture | Pure Titanium Grade 4 (ASTM F67) | Pure Titanium (ASTM F67) | |
| Diameter | 4.0 | 4.0 | |
| Height | 1.52 | 1.5 | |
| Sterilizati
on | Sterilie | Sterilie | |
| Shelf life | 5years | - | |
| S E | The Cover Cap has same material and indication for use and similar design and
technological characteristics as the predicate device, such as the CTi Cover Cap | | |

4

OSSTEM Implant Co., Ltd. #507-8 Geoie3-Dong Yeonie-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

1. Indication for use :
  The SMARTbuilder 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.
1. Review :
  The SMARTbuilder system has the same material and indication for use and similar design and technological characteristics as the predicate device.
1. Summary of nonclinical testing
  Biocompatibility evaluation for SMARTbuilder System is not considered because SMARTbuilder System, which is made with titanium alloy, has been generally and widely used as a dental material such as implant for a long time
1. Summary of clinical testing No clinical studies are submitted
1. Conclusion :

Based on the information provided in this premarket notification Osstem Implant Co., Ltd. concludes that the SMARTbuilder system is substantially equivalent to the predicate devices as described herein

5

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows a logo for the Department of Health & Human Services, USA. The logo consists of a circular arrangement of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, represented by thick, stylized lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT
3 2012

Osstem Implant Company, Limited C/O Mr. Patrick Lim Hiossen, Incorporated 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030

Re: K120951

Trade/Device Name: SMARTbuilder System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY, NHA Dated: August 28, 2012 Received: September 12, 2012

Dear Mr. Lim:

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.

6

Page 2- Mr. Lim

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 reportung (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); 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

R. Staley

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital,

Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

7

OSSTEM Implant Co., Ltd.

#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

510(k) Number K_12095 1

Device Name : SMARTbuilder system

Indication for use : SMARTbuilder System is a metal (Non-resorbable membrane) device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.

Prescription Use X (Per 21CFR801 Subpart D) OR

Over-The-Counter Use (Per 21 CFR807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russo

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K12095