Multi Angled Abutment system is intended for use with a dental implant to provide support for prosthetic restorations such as bridges, or overdentures.

Device Description

The Multi Angled Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration. The Multi Angled Abutment is used with Esthetic -low Cylinders (only Non-Hex) in the US System, K62030 and connected to HTIII SA Fixture in the HTIII SA Fixture System, K101096. The Multi Angled Abutment system consists of Abutment combined carrier that is tool to carry Multi angled abutment. and Abutment Screw. The Multi Angled Abutment system is exactly same with Multi Angled Abutment (K123755) except combined carrier. Carrier is just to carry the Multi Angled Abutment to implanted Fixture.

AI/ML Overview

The provided document is a 510(k) summary for the OSSTEM Multi Angled Abutment system. This submission does not describe a study to prove a device meets acceptance criteria related to its performance in terms of accuracy, sensitivity, specificity, or other similar metrics.

Instead, this 510(k) summary is for a medical device (dental abutment). The "study" described herein is a comparison to a legally marketed predicate device to establish substantial equivalence for market clearance. This is a common regulatory pathway for medical devices and does not involve the types of performance studies or acceptance criteria typically associated with artificial intelligence or diagnostic software.

Therefore, many of the requested sections (Table of acceptance criteria, sample sizes, expert qualifications, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission and device.

Here's a breakdown of the relevant information from the document in response to your request:

1. Table of acceptance criteria and the reported device performance

Not applicable. This is a 510(k) submission for a mechanical dental device, not a diagnostic or AI-driven aid with performance metrics like sensitivity or specificity. The "performance" assessment here is focused on mechanical and material equivalence to a predicate device.

Instead, the submission states:
"The Multi Angled Abutment system is merely improved for movement convenience of abutment by combination of carrier therefore, The Multi Angled Abutment is nothing changed from predicated Multi Angled Abutment (K123755) except combined carrier"

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No "test set" in the context of performance metrics was used. The evaluation centered on design and material comparison to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No a "ground truth" or expert review of performance data was conducted for this type of device submission. The assessment was done by the manufacturer's engineers and subsequently by the FDA reviewers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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

Not applicable. This device is not an AI-assisted diagnostic tool.

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

Not applicable. This device is not an algorithm.

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

Not applicable. The "ground truth" equivalent in this context is the design specifications, material properties, and intended use of the legally marketed predicate device (K123755). The new device is compared against these established characteristics to demonstrate substantial equivalence.

8. The sample size for the training set

Not applicable. No training set was used.

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

Not applicable.

Summary of the Study/Evaluation for Substantial Equivalence:

The "study" or evaluation performed for the K132067 submission was a comparison of the Multi Angled Abutment system to a legally marketed predicate device (Multi Angled Abutment, K123755).

Acceptance Criteria (Implicit for Substantial Equivalence): The primary "acceptance criterion" was to demonstrate that the new device is as safe and effective as the predicate device, or is substantially equivalent. This means:
- Same intended use.
- Same or similar technological characteristics.
- If there are differences in technological characteristics, those differences do not raise different questions of safety and effectiveness.
Reported Device Performance (in context of substantial equivalence): The document reports that the Multi Angled Abutment system is "exactly same with Multi Angled Abutment (K123755) except combined carrier." The carrier is described as "just to carry the Multi Angled Abutment to implanted Fixture." This modification is stated to be "merely improved for movement convenience of abutment."
- Intended Use: Identical for both new and predicate device: "intended for use with a dental implant to provide support for prosthetic restorations such as bridges, or overdentures."
- Abutment Angle (°): 17, 30 (same for both)
- Platform (Ø): 4.8 (same for both)
- Connection: The core abutment components are identical to the predicate (K123755). The only difference is the addition of a combined carrier.
Nonclinical Testing: "The risks associated with the modification were evaluated via a DCAS table and it was determined that no performance testing is needed. However, minor modifications were made to the labeling." This indicates that the manufacturer determined the change (addition of a carrier) did not warrant new mechanical or material testing as the core functional components of the abutment remained unchanged from the predicate.
Clinical Testing: "No clinical studies are submitted."

In essence, the entire argument for meeting the "acceptance criteria" for market clearance (substantial equivalence) is built on the claim that the device is fundamentally the same as its predicate, with a minor, non-performance-affecting addition.

Summary

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KNB2067

DEC 2 0 2013

Image /page/0/Picture/2 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The address is #507-8 Geoje3-Dong 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 is www.osstem.com.

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.

OSSTEM Implant Co., Ltd. #507-8 Geoje3-Dong Yeonje-Gu

Mr. Hee Kwon Son

+82 51 850 2575

HIOSSEN Inc.

Patrick Lim 888 678 0001

Busan, 611-804, Republic of Korea

85 Ben Fairless Dr. Fairless Hills, PA 19030

Date: June 27, 2013

Company and Correspondent making the submission:

Submitter`s Name :
Address :
Contact :
Phone:
Correspondent`s Name:
Address:
Contact:
Phone:
1. Device :

Trade or (Proprietary) Name : Common or usual name : Classification Name :

Multi Angled Abutment system Dental Abutment Abutment, implant, dental, endosseous 21CFR872.3630 Class II NHA

1. Predicate Device :
  Multi Angled Abutment, OSSTEM Implant Co., Ltd., K123755
1. Description :
  The Multi Angled Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration.

The Multi Angled Abutment is used with Esthetic -low Cylinders (only Non-Hex) in the US System, K62030 and connected to HTIII SA Fixture in the HTIII SA Fixture System, K101096

I) The Multi Angled Abutment system consists of Abutment combined carrier that is tool to carry Multi angled abutment. and Abutment Screw.
QS-Q1-505-3(Rev.0)

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Image /page/1/Picture/0 description: The image shows the text "OSSTEM Implant Co., Ltd." The text is in bold, black font and is centered on a white background. The text appears to be the name of a company.

#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

1. The Multi Angled Abutment system is exactly same with Multi Angled Abutment (K123755) except combined carrier

	Multi Angled Abutment system	Multi Angled Abutment
Manufacturer	Osstem Implant Co., Ltd	Osstem Implant Co., Ltd
510(k) Number	New	K123755
Design	Image: Multi Angled Abutment system design	Image: Multi Angled Abutment design
Intended use	Multi Angled Abutment is intended foruse with a dental implant to providesupport for prosthetic restorations suchas bridges, or overdentures.	Multi Angled Abutment is intended foruse with a dental implant to providesupport for prosthetic restorations suchas bridges, or overdentures.
AbutmentAngle(°)	17, 30	17, 30
platform(Ø)	4.8	4.8
Connection	The Multi Angled Abutment system is exactly same with Multi AngledAbutment(K123755) except combined carrier.Carrier is just to carry the Multi Angled Abutment to implanted Fixture

- Substantial Equivalence Matrix

Indication for use :

The Multi Angled Abutment system is intended for use with a dental implant to provide support for prosthetic restorations such as bridges, or overdentures.

ਾਂ

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Image /page/2/Picture/0 description: The image shows the logo for OSSTEM Implant. The logo is in black and white and features the word "OSSTEM" in a stylized font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and modern, and it is likely used to represent a company that manufactures or sells dental implants.

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

6. Review :

The Multi Angled Abutment system is merely improved for movement convenience of abutment by combination of carrier therefore, The Multi Angled Abutment is nothing changed from predicated Multi Angled Abutment (K123755) except combined carrier

7. Summary of nonclinical testing

The risks associated with the modification were evaluated via a DCAS table and it was determined that no performance testing is needed. However, minor modifications were made to the labeling.

1. Summary of clinical testing No clinical studies are submitted

9. 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 Multi Angled Abutment system is substantially equivalent to the predicate devices as described herein.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

Public Health Service

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

December 20, 2013

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

Re: K132067

Trade/Device Name: Multi Angled Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 31, 2013 Received: November 25, 2013

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.

ff 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/ResourcesforYou/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

mer -

for

Erin I. Keith, M.S. 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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DSSTEM Implant Co., Lt #507-8 Geoje3-Dong Yeonje-Gu Busan, Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

Indications for Use

510(k) Number K 132067

... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ..

Device Name : Multi Angled Abutment system

Indication for use : Multi Angled Abutment system is intended for use with a dental implant to provide support for prosthetic restorations such as bridges, or overdentures.

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)

Mary Mary S. Runner-5
Susan Run DDS, MA 2013-12-20 08:45:50-05-00

QS-Q1-505-2(Rev.0)

Letter(8.5 X I I in)

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.)