Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical dental abutment system and does not mention any software, algorithms, or AI/ML capabilities.

Therapeutic

Yes
The device is intended to replace missing teeth and restore chewing function, which is a therapeutic purpose.

Diagnostic

No

This device is intended to replace missing teeth and restore chewing function (a treatment), not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the CCM Abutment System consists of physical components: UCLA Abutment and titanium abutment screws. The performance studies also detail testing of physical properties like biocompatibility and galvanic reaction.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is for replacing missing teeth to restore chewing function. This is a therapeutic and restorative purpose, not a diagnostic one.
Device Description: The description details a physical component used with a dental implant to support prosthetic restorations. This is a medical device used in a surgical and restorative procedure.
Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information for diagnosis. IVDs are specifically designed for these purposes.
Performance Studies: The performance studies focus on biocompatibility, galvanic reaction, and sterilization, which are relevant to the safety and function of an implantable medical device, not an IVD.

In summary, the CCM Abutment System is a dental implant component used for restoring oral function, not for performing in vitro diagnostic tests.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

NHA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Missing teeth (dental)

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Data:
The subject device was tested to evaluate its substantial equivalence according to the following standards.

Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ● ISO 10993-10:2010 and ISO 10993-11:2006.
Galvanic Reaction Test between CoCr alloy and non-precious metal ●

Below tests were performed for predicate devices and leveraged for the subject device:

End User Steam Sterilization Test according to ISO 17665-1:2006, -2:2009 and ANSI/AAMI ● ST79 referenced in K140806
The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device.

Biocompatibility Test was conducted for the subject devices and it demonstrates that the subject device is biocompatible and substantial equivalence with the predicate device, K161244.

The galvanic reaction testing between the CoCr alloy and non-precious dental alloys, Ti Gr.5. was performed for subject device and compatible implants. As the FDA guidance of "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant abutments", corrosion potential of each CoCr alloy and Ti Gr.5 and couple potential for assembled CoCr alloy and Ti Gr.5 were assessed.

The end user sterilization test was performed for predicate device, K140806 and leveraged for the subject device because the product category, material, manufacturing process, facility, and packaging is the exactly the same as the predicate, K140806.

The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K153350

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K140806, K162099, K161244

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.)

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)

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.

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

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.

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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