The ZENEX FreeMilling & CCM Cast Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

Device Description

ZENEX FreeMilling & CCM Cast Abutment consists of FreeMilling Abutment and CCM Cast Abutment.

ZENEX FreeMilling & CCM Cast Abutment is compatible with the fixtures below:

K number: K211090
Device Name: ZENEX Implant System (ZENEX MULTI&PLUS Fixture)
Dimension Ranges: Diameter 3.75 x 8.5, 10, 11.5, 13, 15; Diameter 4.25 x 7, 8.5, 10, 11.5, 13, 15; Diameter 4.6 x 7, 8.5, 10, 11.5, 13, 15; Diameter 5.05 x 7, 8.5, 10, 11.5, 13, 15; Diameter 5.4 x 7, 8.5, 10, 11.5, 13; Diameter 5.9 x 7, 8.5, 10, 11.5, 13; Diameter 6.75 x 7, 8.5, 10, 11.5, 13

Tolerance of dimension shall be within ± 1% range.

The dimensions of abutments are as following:

Device Name: FreeMilling Abutment
Dimension Ranges: Diameter 4.0/4.5/5.0/5.2/5.7/6.0/6.5/7.0
Gingival Heights (mm): 1.3/1.8/2.8/3.8
Minimum Post height (mm): 4
Angulation: 0°

Device Name: CCM Cast Abutment
Dimension Ranges: Diameter 4.0 / 4.5
Gingival Heights (mm): 0.8 / 2.8
Minimum Post height (mm): 4
Angulation: 0°

The Abutments have below featured:

Name: FreeMilling Abutment
Uses: The Abutment is connected with fixture, and it supports prosthesis which restores tooth function.
Surface: Partial TiN coated in upper
Connection: Screw retained

Name: CCM Cast Abutment
Uses: It is an abutment that is used when making a retained / customized prosthesis.
Surface: NA
Connection: Screw retained

Tolerance of dimensions for Abutments shall be within ± 1% range.

ZENEX FreeMilling & CCM Cast Abutment is provided non-sterile.

Materials:

FreeMilling Abutment is fabricated of Ti-6Al-4V ELI according to ASTM F136-13
CCM Cast Abutment is fabricated of Co-Cr-Mo according to ASTM F1537-11

AI/ML Overview

I'm sorry, but your prompt asks for details about acceptance criteria and a study proving device performance, including a table of acceptance criteria and reported device performance, sample size, ground truth establishment, expert qualifications, adjudication methods, MRMC study information, standalone performance, and training set details.

However, the provided text is a 510(k) summary for a dental abutment, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and the results of a primary clinical or non-clinical performance study. It mentions non-clinical test data for biocompatibility and sterilization, but it doesn't present performance metrics against specific acceptance criteria in the format you've requested for a device that relies on a performance study to prove its criteria.

The 510(k) summary establishes equivalence based on:

Indications for Use: Same as predicate.
Technological Characteristics: Similar design, dimensions (with minor, deemed non-critical differences), materials, and sterilization methods.
Non-Clinical Test Data: Biocompatibility and sterilization (often leveraged from predicate devices or performed according to recognized standards).

Therefore, I cannot extract the specific information you've requested about acceptance criteria and a study proving those criteria from the given text. The document's purpose is to argue substantial equivalence, not to present a standalone performance study with detailed acceptance criteria and results.

Summary

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Izenimplant Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620

Re: K231557

Trade/Device Name: ZENEX FreeMilling & CCM Cast Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: May 30, 2023 Received: May 30, 2023

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

ZENEX FreeMilling & CCM Cast Abutment

Indications for Use (Describe)

The ZENEX FreeMilling & CCM Cast Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

Type of Use (Select one or both, as applicable)
For Therapeutic Use Only (OTC, NDA, or Rx)
For The Cosmetic Use Only (OTC, NDA, or Rx)

X 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

Izenimplant Co., Ltd. Ji-Hwan Jeong 1, 2Dong, 26-32, Suworam 4-Gil, Seotan-Myeon, Pyeongtaek-Si. Gyeonggi 17703 Republic of Korea Email: jjhwan@izenimplant.com Tel. +82-31-662-0657 Fax. +82-31-662-0655

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: ZENEX FreeMilling & CCM Cast Abutment
Common Name: Dental Implant Abutment ●
. Classification Name: Abutment, Implant, Dental, Endosseous
. Product Code: NHA
Panel: Dental
Regulation Number: 872.3630
Device Class: Class II
Date Prepared: 08/24/2023

Predicate Devices:

The subject device is substantially equivalent to the following predicate devices:

Primary Predicate

. K161689, OSSTEM Implant System - Abutment by Osstem Implant Co., Ltd.

Reference devices

K192263, UCLA CCM Abutment by DIO Corporation ●
K211090, ZENEX Implant System by Izenimplant Co., Ltd.

Indication for Use:

The ZENEX FreeMilling & CCM Cast Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

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Device Description:

ZENEX FreeMilling & CCM Cast Abutment consists of FreeMilling Abutment and CCM Cast Abutment.

ZENEX FreeMilling & CCM Cast Abutment is compatible with the fixtures below:

K number	Device Name	Dimension Ranges
K211090	ZENEX Implant System(ZENEX MULTI&PLUS Fixture)	$Ø$ 3.75 x 8.5, 10, 11.5, 13, 15$Ø$ 4.25 x 7, 8.5, 10, 11.5, 13, 15$Ø$ 4.6 x 7, 8.5, 10, 11.5, 13, 15$Ø$ 5.05 x 7, 8.5, 10, 11.5, 13, 15$Ø$ 5.4 x 7, 8.5, 10, 11.5, 13$Ø$ 5.9 x 7, 8.5, 10, 11.5, 13$Ø$ 6.75 x 7, 8.5, 10, 11.5, 13

Tolerance of dimension shall be within ± 1% range.

The dimensions of abutments are as following:

Device Name	Dimension Ranges	GingivalHeights (mm)	Minimum Postheight (mm)	Angulation
FreeMillingAbutment	Ø 4.0/4.5/5.0/5.2/5.7/6.0/6.5/7.0	1.3/1.8/2.8/3.8	4	0°
CCM Cast Abutment	Ø 4.0 / 4.5	0.8 / 2.8	4	0°

The Abutments have below featured:

Name	Uses	Surface	Connection
FreeMillingAbutment	The Abutment is connected with fixture, and itsupports prosthesis which restores tooth function.	Partial TiNcoated inupper	Screwretained
CCM Cast Abutment	It is an abutment that is used when making a retained/ customized prosthesis.	NA	Screwretained

Tolerance of dimensions for Abutments shall be within ± 1% range.

ZENEX FreeMilling & CCM Cast Abutment is provided non-sterile.

Materials:

FreeMilling Abutment is fabricated of Ti-6Al-4V ELI according to ASTM F136-13 ●
. CCM Cast Abutment is fabricated of Co-Cr-Mo according to ASTM F1537-11

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Summaries of Technological Characteristics & Substantial Equivalence Discussion

FreeMilling Abutment

Subject Device		Primary Predicate
Manufacturer	Izenimplant Co.,Ltd	Manufacturer	OSSTEM Implant Co., Ltd.
Product Name	ZENEX FreeMilling & CCM CastAbutment	Product Name	OSSTEM Implant System - Abutment
Model Name	FreeMilling Abutment	Model Name	FreeForm ST Abutment
510(K) Number	K231557	510(K) Number	K161689
Indications for Use	The ZENEX FreeMilling & CCM CastAbutment is intended for use with a dentalimplant to provide support for prostheticrestorations such as crowns, bridges, oroverdentures.	Indications for Use	The OSSTEM Implant System - Abutmentis intended for use with a dental implant toprovide support for prosthetic restorationssuch as crowns, bridges, or overdenture
Design	Image: HexImage: Non-Hex	Design	Image: HexImage: Non-Hex
Hand Milling Only	Yes	Hand Milling Only	Yes
Dimension	DG/HP/HAngle	Dimension	4.0/4.5/5.0/5.2/5.7/6.0/6.5/7.01.3/1.8/2.8/3.88 / 9mm0°	Dimension	DG/HP/HAngle	Dimension	$Φ$ 4.0/5.0/5.5/6.0/7.01.5 / 3.59/10.5mm0°
Material	Ti-6Al-4V ELI	Material	Ti-6Al-4V ELI
Surface	Partial TiN coated in upper	Surface	Partial TiN coated in upper
Sterilization	End User Sterilization	Sterilization	End User Sterilization
SE Discussion	The Subject Device and Primary Predicate (K161689) have same indications for use,diameters, material, and sterilization method. The differences between two devices aregingival height and post height, however, the values are very similar and these differencesare not important factor for the device performance. Both devices are substantialequivalent.

CCM Cast Abutment

		Subject Device		Reference Device
Manufacturer		Izenimplant Co.,Ltd		DIO Corporation
Product Name		ZENEX FreeMilling & CCM Cast Abutment		UCLA CCM Abutment
Model Name		CCM Cast Abutment		UCLA CCM Abutment
510(K) Number		K231557		K192263
Design		Image: red abutment	Image: white abutment	Image: red abutment	Image: white abutment
		Hex	Non-Hex	Hex	Non-Hex
Dimension	D	4.0 / 4.5		4.0/4.5
	G/H	0.8 / 2.8		1.0/3.0
	P/H	10.0		10.0
	Angle	0°		0°
Material		CCM AbutmentPlastic Sleeve	CoCrMo AlloyPOM	CCM AbutmentPlastic Sleeve	CoCrMo AlloysPOM
Surface		Non-Coating		Non-Coating
Sterilization		Steam Sterilization by user(Delivered non sterile)		Steam Sterilization by user(Delivered non sterile)

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SE Discussion	The Subject Device and Reference Device (K192263) have same indications for use, diameters, material, and sterilization method. The differences between two devices are gingival height and post height, however, the values are very similar, and these differences are not important factor for the device performance. Both devices are substantial equivalent.
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Non-Clinical Test Data

Below tests were performed on subject device:

Biocompatibility Testing on subject CCM Cast Abutment according to ISO 10993-1:2020 ●
End User Sterilization Validation Test Report on subject CCM Cast Abutments according to ANSI/AAMI ST79, ISO 17665-1,-2, ISO 11737-1,-2, and ISO 11138-1

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

. End User Sterilization Validation Test Report for Abutments made with Ti-6Al-4V ELI according to ANSI/AAMI ST79. ISO 17665-1.-2. ISO 11737-1.-2. and ISO 11138-1 referenced in K211090
Biocompatibility testing for Abutments made with Ti-6Al-4V ELI according to ISO 10993-1:2009 referenced in K211090

The surface modification information of TiN Coating such as chemical composition, coating thickness, abrasion characteristics, and SEM imaging provided in the previous cleared device, K211090 can be leveraged for the subject FreeMilling abutment.

The end user sterilization test was performed for predicate device, K211090 and leveraged for the subject device made with Ti-6A1-4V ELI because the product material, manufacturing process, sterilization methods and packaging of both products are exactly same.

The end user sterilization validation is performed on the subject CCM Cast Abutment according to ISO 17665-1 and ISO 17665-2. The worst-case construct was tested, and results demonstrated equivalence to the predicate device.

The Biocompatibility Test was conducted on the predicate device, K211090 and leveraged for the subject device made with Ti-6Al-4V ELI because both products are manufactured with same materials and manufacturing process. It demonstrates that the subject device is biocompatible and substantial equivalence with the predicate.

Biocompatibility Testing was performed according to ISO 10993-1:2009, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," and to the FDA Guidance document, "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff", Document issued on: June 16, 2016", for subject CCM Cast Abutments

MR Environment Condition

Non-clinical worst-case MRI review was performed to evaluate the metallic. Dentis I-FIX Abutment in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry 0., Jana G. Delfino, and Sunder Rajan. 'Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodied, dental abutments and, fixation screws) and material composition. Rationale addressed parameters per the FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.

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

Conclusion

ZENEX FreeMilling & CCM Cast Abutment constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, ZENEX FreeMilling & CCM Cast Abutment and its predicates are substantially equivalent.

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.)