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 HT3 SA Fixture System, K101096. The Multi Angled Abutment consists of Abutment and Abutment Screw. The Multi angle Abutment is used to elevate restoration platform when restoration to implant level is not practical due to depth or angle of implant for the edentulous patients in Anterior and Posterior, not customizable and can't be use a single product.

AI/ML Overview

This document describes the K12-3755 Multi Angled Abutment, a dental device. The 510(k) summary provided does not contain the typical details of a study proving a device meets acceptance criteria as this is a premarket notification for substantial equivalence. Instead, it focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not relevant or not provided for this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission seeking substantial equivalence for a dental abutment, the "acceptance criteria" are primarily established by demonstrating equivalency in material, design, function, and intended use to a predicate device, and ensuring safety through non-clinical testing. Performance is measured against the predicate.

Feature/Test	Acceptance Criteria (Implicit from Predicate)	Reported Device Performance (Multi Angled Abutment)
Material Composition	Same as predicate (Titanium alloy)	Made of the same material (Titanium alloy)
Manufacturing Process	Same as predicate	Same manufacturing process
Chemical Composition	Same as predicate	Same chemical composition
Body Contact	Same as predicate	Same body contact characteristics
Intended Use	"For use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures." (Predicate: K110308)	"Intended for use with a dental implant to provide support for prosthetic restorations such as bridges, or overdentures." (Slight wording difference, but identical core intent)
Design Characteristics (Dimensions)	Predicate dimensions: A(°): 17, 30; B(mm): 5, 5.1, 5.5, 5.6, 6, 6.1, 6.5, 6.6, 7.5, 7.6; C(Ø): 2.84, 2.88, 3.39, 3.43; D(Ø): 4.9	Multi Angled Abutment dimensions: A(°): 17, 30; B(mm): 3.17, 3.4, 4.17, 4.4, 4.76, 4.86, 5.17, 5.4, 5.76, 5.86, 6.76, 6.86; C(Ø): 2.88, 3.43; D(Ø): 4.8. (Note: different range of 'B' and 'D' but within a similar functional context for dental abutments)
Connection (Abutment/Implant)	No modification to the abutment/implant connection compared to the predicate	No modification to the abutment/implant connection, no difference compared to predicate device (K110308)
Safety Tests	Compliance with applicable international and US regulations (biocompatibility, risk analysis, dimension inspection)	Biocompatibility considered, risk analysis and dimension inspection conducted.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. This submission is for substantial equivalence and relies on non-clinical testing and comparison to a predicate device, not a human clinical trial with a "test set" in the traditional sense.
Data Provenance: The manufacturer, OSSTEM Implant Co., Ltd., is located in Busan, Republic of Korea. The non-clinical testing data would originate from their internal processes or contracted labs. The data is "retrospective" in the sense that it's a comparison to an already marketed device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts & Qualifications: Not applicable. Ground truth for a clinical test set is not relevant for this type of 510(k) submission, which focuses on non-clinical aspects and comparison to a predicate device's established performance and safety record.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable for the reasons stated above.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

MRMC Study: Not applicable. This device is a passive dental abutment, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable. This device is a physical dental component, not an algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness of the predicate device (Prosthetic System, K110308). The new device demonstrates substantial equivalence through material comparison, design comparison, non-clinical safety tests (biocompatibility, risk analysis, dimension inspection), and alignment of intended use. There is no pathology or outcomes data from a clinical study for this specific device.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable for the reasons stated above.

Summary

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K12-3755

SSTEM Implant Co., Lt 507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea

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

510(k) Summary

APR 2 6 2013

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

Date: November 30, 2012

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 :

OSSTEM Implant Co., Ltd. #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804, Republic of Korea Mr. Hee Kwon Son +82 51 850 2575

HIOSSEN Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Patrick Lim 888 678 0001

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

1. Predicate Device :
  Prosthetic System, OSSTEM Implant Co., Ltd., K110308

4. 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 HT3 SA Fixture System, K101096

The Multi Angled Abutment consists of Abutment and Abutment Screw.

QS-Q1-505-3(Rev.0)

Letter(8.5 X 11in)

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1. The Multi angle Abutment is used to elevate restoration platform when restoration to implant level is not practical due to depth or angle of implant for the edentulous patients in Anterior and Posterior, not customizable and can't be use a single product
1. The Multi Angled Abutment is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
1. The Multi Angled Abutment is substantially equivalent in design, function and intended use to Prosthetic System (K110308) of OSSTEM Implant Co., Ltd.,

	Multi Angled Abutment	Prosthetic System
Manufacturer	Osstem Implant Co., Ltd	Osstem Implant Co., Ltd
510(k) Number	New	K110308
Design	Image: Multi Angled Abutment design	Image: Prosthetic System design
	Image: Multi Angled Abutment design details prevent exposure of the screw hole and form the natural gingival shape	Image: Prosthetic System design details
Intended use	Multi Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.	Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

- Substantial Equivalence Matrix

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OSSTEM
IMPLANT

STEM Impla

07-8 Geoje3-Dong Yeonje-Gu Busan, 611 el: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

Dimension
A( $°$ )	17, 30	17, 30
B(mm)	3.17, 3.4, 4.17, 4.4, 4.76, 4.86,5.17, 5.4, 5.76, 5.86, 6.76, 6.86	5, 5.1, 5.5, 5.6, 6, 6.1, 6.5, 6.6, 7.5,7.6
C( $Ø$ )	2.88, 3.43	2.84, 2.88, 3.39, 3.43
D( $Ø$ )	4.8	4.9
Connection	There is no modification to the abutment/implant connect has been made.Therefore, There is no difference in connection part when compare withpredicate device(K110308)

1. Indication for use :
  The Multi Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as bridges, or overdentures.
1. Review :
  The Multi Angled Abutment has similar material, indication for use, design and technological characteristics as the predicate device.

7. Summary of nonclinical testing

Safety tests including biocompatibility have been considered to ensure the devices comply with the applicable international and US regulations as below.

The Multi Angled Abutment is made of the same materials, manufacturing process, chemical composition, body contact with the predicate devices, Prosthetic System, OSSTEM Implant Co., Ltd., K110308 also, Risk analysis and dimension inspection were conducted

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

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

Letter(8.5 X 11in)

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Image /page/3/Picture/0 description: The image shows the word "OSSTEM" in a stylized font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller font. The letters are black and the background is white. There is a degree symbol after the word "OSSTEM".

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

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

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

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a person with outstretched arms, composed of three curved lines.

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

April 26, 2013

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

Re: K123755

Trade/Device Name: Multi Angled Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: March 13, 2013 -Received: March 27, 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.

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 devicerelated 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,

Image /page/5/Figure/8 description: The image shows a signature and a digitally signed statement. The signature reads "Susan Runner, DDSMA". The digitally signed statement indicates that the document was signed by Mary S. Runner-S on April 26, 2013, at 11:24:11 -04'00'. The statement also includes details such as DN, organizational units (HHS, FDA, People), and a numerical identifier.

for

Anthony D. Watson, B.S., M.S., M.B.A. 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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OSSTEM Implant C

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

Indications for Use

K123755 510(k) Number K

Device Name : Multi Angled Abutment

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

Prescription Use_ ਮ (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)

	Digitally signed by Mary S. Runner
	DN: c=US, o=U.S. Government,
	ou=HHS, ou=FDA, ou=People,
	cn=Mary S. Runner S,
	0.9.2342:19200300.100.1.1=13000
	87950
	Date: 2013.04.26 11:21:11 -04'00'

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

510(k) Number:	K123755
----------------	---------

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

Letter(8.5 X 1 im)

. [ .

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.)