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.

Device Description

SB Anchor is used for connecting with Healing abutment or Cover Cap on the top of the SB Anchor to fix the SMARTbuilder that is predicated 510(K), K120951, K130840. The SB Anchor has the same material, indication for use, technological characteristics and similar design as the predicate device, Height in the SMARTbuilder System. The SB Anchor is designed for use with NT Fixture connection (K081078) and TS SA Fixture connection (K121995).

AI/ML Overview

This document is a 510(k) premarket notification for a dental device called "SB Anchor." It asserts substantial equivalence to a predicate device, the "SMARTbuilder System." The document does not describe a study involving an AI/CADe device or its performance criteria/results.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device conformance for an AI-based system. The provided text is a regulatory submission for a conventional medical device (an endosseous dental implant abutment).

Specifically, the document states:

"No clinical studies are submitted" (Page 5, Section 8). This explicitly indicates that no clinical performance data for the device, including any related to AI or a study demonstrating its meeting of acceptance criteria, is present.
The entire document revolves around demonstrating substantial equivalence to a predicate device based on material, indication for use, and technological characteristics of a physical implant component, not a software algorithm.

Based on the provided text, the following information is not available:

A table of acceptance criteria and the reported device performance: Not applicable as this is not an AI/CADe device and no performance study is described.
Sample size used for the test set and the data provenance: Not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
If a standalone performance (algorithm only without human-in-the-loop performance) was done: No.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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

Auqust 21, 2014

OSSTEM Implant Company, Limited C/O Mr. Patrick Lim Manager HIOSSEN Incorporated 85 Ben Fairless Drive Fairless Hills, PA 19030

Re: K140600

Trade/Device Name: SB Anchor Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 23, 2014 Received: July 10, 2014

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.

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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 reporting (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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,

Mary S. Runner -S

Erin I. Keith, M.S. 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 a bold, sans-serif font, with the word "OSSTEM" in a larger font size than "Implant Co., Ltd." The address is listed as 203, Geoje-daero, Yeonje-Gu Busan, 611-804 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.

Indications for Use Statement

Indications for Use

140600 510(k) Number K

Device Name : SB Anchor

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 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)

Letter(8.5 X 11in)

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Image /page/3/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" also appearing in orange next to the company name. The contact information includes the address, phone number, fax number, and website.

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: February 21, 2014

Company and Correspondent making the submission:

- Submitter's Name :	OSSTEM Implant Co., Ltd.
- Address :	203, Geoje-daero, Yeonje-GuBusan, 611-804, 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:	Patrick Lim
- Phone:	888 678 0001
2. Device :

Trade or (Proprietary) Name :	SB Anchor
Common or usual name :	Dental Abutment
Classification Name :	Endosseous dental implant abutment21CFR872.3630Class IINHA

1. Predicate Device :
  SMARTbuilder System, OSSTEM IMPLANT CO.,LTD (K120951)
1. Description :
  SB Anchor is used for connecting with Healing abutment or Cover Cap on the top of the SB Anchor to fix the SMARTbuilder that is predicated 510(K), K120951, K130840

The SB Anchor has the same material, indication for use, technological characteristics and similar design as the predicate device, Height in the SMARTbuilder System

The SB Anchor is designed for use with NT Fixture connection (K081078) and TS SA Fixture connection (K121995)

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

Letter(8.5 X 11in)

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Image /page/4/Picture/0 description: The image shows the logo for Osstem Implant. The logo is orange and black. The word "OSSTEM" is in orange, and the word "IMPLANT" is in black. The logo is simple and modern.

OSSTEM Implant Co., Ltd.

203, Geoje-daero, Yeonje-Gu Busan, 611-804 Republic of Korea
Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

Material	Titanium alloy Ti-6Al-4V(ASTM F 136)	Compatible connection /Dimension	NT FixtureConnectionTS SA FixtureConnection	Diameter : 3.5, 4.0, 5.0Length: 6.35 ~ 9.85Diameter : 3.3, 3.7, 4.2,4.25, 4.4, 4.6, 4.63, 4.65,4.9, 5.05, 5.08, 5.1Length: 7.0~15
surface treatments	none	Method of Sterilization		Radiation (Gamma)

- Substantial Equivalence Matrix

	SB Anchor	SMARTbuilder SystemHeight
510(k)	Proposed	K120951
Manufacturer	OSSTEM Implant Co., Ltd.	OSSTEM Implant Co., Ltd.	OSSTEM Implant Co., Ltd.
Design	Image: SB Anchor Design	Image: SB Anchor Design	Image: SMARTbuilder System Height Design
CompatibleFixture	NT Fixture (K081078)	TS SA Fixture (K121995)	GS III System (K091208)
Indicationfor use	SMARTbuilder System is ametal (Non-resorbablemembrane) deviceintended for use with a dentalimplant to stabilize andsupport of bone graft in dento-alveolar bony defect sites.	SMARTbuilder System is ametal (Non-resorbablemembrane) deviceintended for use with a dentalimplant to stabilize and supportof bone graft in dento-alveolarbony defect sites.	SMARTbuilder is a metaldevice intended for use with adental implant to stabilize andsupport of bone graft in dento-alveolar bony defect sites.
Material	Titanium alloy Ti-6Al-4V(ASTM F 136)	Titanium alloy Ti-6Al-4V(ASTM F 136)	Titanium alloy Ti-6Al-4V(ASTM F 136)
Dimension	Diameter : 3.5, 4.0, 5.0Length: 6.35 ~ 9.85	Diameter : 3.3, 3.7, 4.2, 4.25,4.4, 4.6, 4.63, 4.65, 4.9, 5.05,5.08, 5.1Length: 7.0~ 15	Diameter : 3.3, 4Length: 7.15 ~ 9.85
surfacetreatments	None	None	None
Sterilization	Sterile	Sterile	Sterile
Shelf life	8years	8years	8years
SE	The SB Anchor has the same material, indication for use, technological characteristics and similardesign as the predicate device, Height in the SMARTbuilder SystemProduct name is changed SMARTbuilder System, Height to SB Anchor and addition variousanchor shape products to apply various connection structure

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

Letter(8.5 X 11in)

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Image /page/5/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 and is located below the word "OSSTEM."

DSSTEM Implant Co., Ltd.

03, Geoje-daero, Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

1. 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.
1. Review :
  The SB Anchor has the same material, intended for use and technological characteristics as the predicate device.
1. Summary of nonclinical testing
  Biocompatibility evaluation for SB Anchor is not considered because material of SB Anchor is same with Height of SMARTbuilder System(K120951)
1. Summary of clinical testing No clinical studies are submitted
1. 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 SB Anchor is substantially equivalent to the predicate devices as described herein.

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)