The CCM Abutment System is intended to replace missing teeth to restore chewing function. The CCM Abutment System can be placed in support of single or multiple-unit restorations including, cement retained, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

Device Description

CCM Abutment System is used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. CCM Abutment System consists of UCLA Abutment and titanium abutment screws. All subject abutments are intended to be cast at zero angulations and placed on dental implant bodies which do not require angle correction.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA, asserting "substantial equivalence" of the CCM Abutment System to previously marketed devices. These types of documents focus on comparing a new device to existing ones to demonstrate similar safety and effectiveness, rather than presenting a detailed study proving the new device meets specific, pre-defined quantitative acceptance criteria through clinical trials or standalone performance evaluations (especially relevant for AI/ML devices). This document describes a dental implant abutment system, which is a physical device, not an AI/ML-driven medical device. Therefore, the information typically requested for AI/ML device performance, such as sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not applicable to this document.

The document primarily relies on non-clinical data to demonstrate substantial equivalence, focusing on materials, design, indications for use, and manufacturing processes compared to predicate devices.

Here's the information that can be extracted relevant to acceptance and performance for this physical device, framed in the context of "substantial equivalence" rather than "meeting acceptance criteria" in the way an AI/ML device would:

Acceptance Criteria and Device Performance (for a physical dental abutment system)

The "acceptance criteria" here are implicitly tied to demonstrating substantial equivalence to legally marketed predicate devices. The performance is assessed through non-clinical testing and comparison of attributes.

Since this is a 510(k) for a physical dental abutment, the "acceptance criteria" are not quantitative performance metrics in the same way they would be for an AI/ML device. Instead, they are about demonstrating that the device is as safe and effective as predicate devices.

Table of "Acceptance Criteria" (Implicit for 510(k)) and Reported Device Performance:

Feature/Test	Implicit "Acceptance Criteria" (Demonstrate equivalence to predicate)	Reported Device Performance / Justification
Intended Use	Same as predicate devices	The CCM Abutment System is intended to restore chewing function by replacing missing teeth, supporting single or multiple-unit restorations (cement-retained, screw-retained, fixed bridgework), and is for one/two-stage surgical procedures with delayed loading. This is stated to be the same as the primary predicate (K153350) and aligns with the general use of the reference predicates (K140806, K162099, K161244).
Technological Characteristics (Design, Dimension, Principle of Operation, Restoration Angulations)	Similar to predicate devices, with differences not raising new safety/effectiveness questions.	Similarities: Identical machining, manufacturing process, angulation (No Angle), and principle of operation (screw-retained/cement-retained depending on part). Differences: Slight differences in specific dimensions (diameters and lengths) of various abutment parts (UCLA Abutment, Burn out core cylinders/caps, Multi-unit CCM Cylinder) compared to predicates are noted but are considered not to raise new questions of safety or effectiveness. The device maintains "No Angle" for restoration angulations, consistent with predicates.
Material Composition	Equivalent to predicate devices, or justified if different.	Difference: Subject device uses Co-Cr-Mo Alloy and Poly Diacetate. The primary predicate (K153350) uses Titanium Alloy and Poly Diacetate. Justification: Reference predicate (K161244) uses Co-Cr-Mo Alloy, and biocompatibility testing was performed on the subject device to support the material difference. Galvanic reaction testing was also performed between CoCr alloy and Ti Gr.5.
Biocompatibility	Meets established standards (ISO 10993).	Biocompatibility tests performed according to ISO 10993-1, -3, -5, -10, -11. Results "met the criteria of the standards" and "demonstrates that the subject device is biocompatible and substantial equivalence with the predicate device, K161244."
Sterilization	Meets established standards (ISO 17665, ANSI/AAMI ST79).	End User Steam Sterilization Test referenced from predicate K140806. Justified because "product category, material, manufacturing process, facility, and packaging is the exactly the same as the predicate."
Galvanic Reaction	Acceptable corrosion potential between alloys.	Testing performed for CoCr alloy and Ti Gr.5 as per "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant abutments." Assessed corrosion potential and couple potential. "Results...met the criteria of the standards."
Performance Validation (General Statement)	Supposed to performance and product validations prior to release.	"The subject device has been supposed to performance and product validations prior to release." (General statement, specific test data or detailed results not provided in this summary.)

Study Details (as applicable to a physical device 510(k) submission):

Sample size used for the test set and the data provenance:
- Not applicable in the context of an AI/ML device. This document does not refer to a "test set" of patient data for algorithm evaluation.
- For the non-clinical tests (biocompatibility, galvanic reaction), the "sample size" would refer to the number of physical device units tested according to the respective ISO/ASTM standards. These details are not provided in this summary but would be part of the full submission. The provenance is internal lab testing for a new device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in this context is implicitly established by the standards themselves (e.g., ISO 10993 specifications for biocompatibility) and engineering principles for mechanical functionality. Human expert consensus on a test set of images or data is not a component of this submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This refers to a process for resolving discrepancies in expert labeling or diagnoses, which is not relevant for this physical device testing.
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 is a study design for evaluating diagnostic AI, not a physical dental device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This pertains to AI/ML software.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" is defined by the specific criteria and methodologies outlined in the referenced international standards (e.g., ISO 10993 for biocompatibility, ISO 17665 for sterilization). For galvanic reaction, it's based on "corrosion potential" and "couple potential" as assessed per FDA guidance for dental implants.
The sample size for the training set:
- Not applicable. This is for AI/ML model development.
How the ground truth for the training set was established:
- Not applicable. This is for AI/ML model development.

In summary, this document is a regulatory communication for a Class II physical medical device, not an AI/ML-driven diagnostic tool. As such, the requested details related to AI/ML study design and performance criteria are not present because they are not relevant to the type of device and submission being reviewed. The "study" proving the device meets "acceptance criteria" is the set of non-clinical bench tests and comparisons performed against established predicate devices and international standards, demonstrating "substantial equivalence."

Summary

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March 16, 2018

InnoBioSurg Co., Ltd. April Lee Consultant Withus Group Inc. 2531 Pepperdale Drive Rowland Heights, California 91748

Re: K173120

Trade/Device Name: CCM Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: February 14, 2018 Received: February 14, 2018

Dear April Lee:

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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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 (OS) regulation (21 CFR Part 820); 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.

Andrew I. Steen -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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Indications for Use

510(k) Number (if known)

K173120

Device Name CCM Abutment System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter

InnoBioSurg Co., Ltd. Bo-reum Yoo 44-19, Techno 10-ro, Yuseong-gu, Daejeon, 34027 Republic of Korea Email: bryoo@ibsimplant.com Tel. +82-42-933-2879 Fax. +82-42-933-2881

Official Correspondent

Withus Group Inc April Lee 106 Superior Irvine CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122

Device Information

Trade Name: CCM Abutment System
Common Name: Dental Abutment System
. Classification Name: Endosseous dental implant abutment
Product Code: NHA
. Panel: Dental
Regulation Number: 872.3630
Device Class: Class II
Date prepared: 03/16/2018

Primary Predicate

K153350, IBS Implant System by Innobiosurg Co., Ltd.

Reference Predicates

K140806,IBS Implant System by Innobiosurg Co., Ltd
K162099, IBS Implant System II by Innobiosurg Co., Ltd.
K161244, s-Clean OneQ-SL Narrow Implant System by Dentis Co., Ltd.

Device Description

UCLA Abutment

UCLA Abutments are pre-manufactured prosthetic abutments directly connected to the endosseous dental implant intended for permanent restoration, for either single or multiple tooth screw retained restorations. The lower part of the abutment which connects directly to the implant is made of Co-Cr-Mo alloy, and the upper part is made of plastic (Poly Diacetate). The plastic part is dissolved once the casting is done. The abutment screw is connected to the implant by a prosthetic screw, supplied with the abutment, and made of Ti-6AL-4V Eli. UCLA Abutments are intended for no angulation and straight implantation only. The abutments are supplied non-sterile, to be steam sterilized by the user according to the labeling, and intended for single use.

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Multi-unit CCM Cylinder

Multi-unit CCM Cylinders are used in conjunction with screw retained type Abutment to provide support for screw type final prosthesis, and for fabrication of custom abutment for screw retained restorations.

The subject device is compatible with the following Implants:

K number	Compatible Implants
K140806	IBS Implant system
K152520	Magicore System
K153350	IBS Implant System

The CCM Abutment system is provided non-sterile and packaged separately. The abutments should be sterilized before use. Abutment screw (OIAS400) was cleared from K140806.

The UCLA abutments, Burn out core cylinder and cap are not intended to be cast at angulation or placed to provide angular correction. Plastic sleeve of UCLA Abutment can replace the Non-precious metal (Co-Cr Alloy). All finished devices are final abutments.

The diameters and lengths of the CCM Abutment System are below:

1) UCLA Abutment

The gingival height could be 1-4mm, angulation straight only, length of abutment post of 4-10mm. Assembled torque: 30N·cm

No	Diameter (Ø)	Cuff	Length	Remark
1		1 mm	14 mm
2	4 mm	2 mm	15 mm
3		3 mm	16 mm
4		4 mm	17 mm
5		1 mm	14 mm
6	4.5 mm	2 mm	15 mm
7		3 mm	16 mm
8		4 mm	17 mm	Hex/Non-Hex
9		1 mm	14 mm
10	5 mm	2 mm	15 mm
11		3 mm	16 mm
12		4 mm	17 mm
13		1 mm	14 mm
14	5.5 mm	2 mm	15 mm
15		3 mm	16 mm
16		4 mm	17 mm

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