Dentis I-FIX Abutment consists of I-FIX Angled Type Fixture Healing Abutment, I-FIX Angled Type Fixture Healing Abutment Screw, and I-FIX Abutment Screw.

I-FIX Angled Type Fixture Healing Abutment and I-FIX Angled Type Fixture Healing Abutment Screw are compatible with following Implant Systems:
Proprietary Name: I-FIX System (Angled Type Fixture)
Compatible Implants (K number): K083586
Implant diameter size: Ø 2.0, 2.5, 3.0 mm
Implant length: 10~16 mm

I-FIX Abutment Screw is only used with I-FIX Cemented Abutment and I-FIX Free Abutment cleared in K083586.

The dimensions of abutments are as following:

I-FIX Angled Type Fixture Healing Abutment: (D) 4.03 X (L) 3.2, 4, 5 and 7 mm, Angulation 0°
I-FIX Angled Type Fixture Healing Abutment Screw: (D) 2.15 X (L) 4.0, 4.8, 6.1 and 8.0 mm, Angulation 0°
I-FIX Abutment Screw: (D) 2.15 X (L) 4.7 mm, Angulation 0°

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

The Abutments have below featured:

I-FIX Angled Type Fixture Healing Abutment: Uses - The healing Abutment is used for protecting inner hole of fixture and adjusting the appropriate height during the healing period. Surface - Non. Materials - Titanium Grade 4.
I-FIX Angled Type Fixture Healing Abutment Screw: Uses - The healing Abutment is used for protecting inner hole of fixture and adjusting the appropriate height during the healing period. Surface - Non. Materials - Ti-6Al-4V ELI.
I-FIX Abutment Screw: Uses - I-FIX Abutment screw is used with the previously cleared devices, K083586 such as I-FIX Cemented and Free Abutment for connecting with fixture. Surface - Non. Materials - Ti-6Al-4V ELI.

I-Fix Angled Type Fixture Healing Abutment and I-FIX Angled Type Fixture Healing Abutment Screw are packaged as a set and provided sterilized. I-FIX Abutment Screw is provided non-sterilized.

Materials:

I-FIX Angled Type Fixture Healing Abutment is fabricated from pure titanium (Conforming to ASTM Standard F67)
I-FIX Angled Type Fixture Healing Abutment Screw and I-FIX Abutment Screw are fabricated from Ti-6Al-4V ELI (Conforming to ASTM Standard F136)

AI/ML Overview

This FDA 510(k) submission for the Dentis I-FIX Abutment indicates that the device is substantially equivalent to predicate devices, meaning it does not require a new study to prove its effectiveness or safety. Instead, the submission relies on existing data from predicate devices and non-clinical testing. Therefore, there is no specific de novo study described for this device with acceptance criteria and reported device performance in the traditional sense of a clinical trial.

However, I can extract the acceptance criteria that were met through non-clinical testing by referring to the standards and guidance mentioned.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with quantitative acceptance criteria and specific numerical reported device performance for the Dentis I-FIX Abutment as one would expect from a de novo clinical study. Instead, it states that various non-clinical tests were performed and that "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device."

Here are the types of criteria that were met, based on the standards cited:

Acceptance Criteria Type	Reported Device Performance
Material Conformance	Meets ASTM Standard F67 (for CP Titanium Gr4) and ASTM Standard F136 (for Ti-6Al-4V ELI)
Sterilization Validation	Meets ISO 11137-1, 2, 3 (for gamma sterilization) and ANSI/AAMI ST79, ISO 17665-1, -2, ISO 11737-1, -2, ISO 11138-1 (for end-user sterilization)
Shelf Life	Meets ASTM F1980
Biocompatibility	Meets ISO 10993-1:2009
Tolerance of Dimension	Within ± 1% range (as stated on page 4)
MRI Safety	Scientific rationale and published literature (e.g., Woods, Terry O., et al., 2019) used to assess magnetically induced displacement force and torque, meeting parameters per FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment."

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

The document does not specify sample sizes for the non-clinical tests performed. These tests are typically conducted on a limited number of device samples in a laboratory setting. The data provenance is also unspecified beyond the general reference to "Non-Clinical Test Data" and the identification of Dentis Co., Ltd. as the manufacturer in Korea.

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)

This section is not applicable as the submission relies on non-clinical engineering and materials testing, not a study requiring expert clinical assessment for ground truth. The "ground truth" here is objective measurement against established engineering and biocompatibility standards.

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

This section is not applicable as there was no clinical study with a test set requiring adjudication of findings.

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

This section is not applicable. The Dentis I-FIX Abutment is a physical dental device, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

This section is not applicable. The device is a physical medical device, not an algorithm.

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

The "ground truth" used for non-clinical testing was based on:

Established international and national standards (e.g., ISO, ASTM, ANSI/AAMI).
Material specifications (e.g., ASTM F67, ASTM F136).
Engineering specifications (e.g., dimensional tolerances).

8. The sample size for the training set

This section is not applicable. There was no "training set" in the context of machine learning or AI development for this physical device. The device design and manufacturing processes are based on established engineering principles and materials science.

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

This section is not applicable for the reasons stated in point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K230203

Trade/Device Name: Dentis I-FIX Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: March 27, 2023 Received: March 27, 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.

{1}------------------------------------------------

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 medical devices and radiation-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 Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K230203

Device Name Dentis I-FIX Abutment

Indications for Use (Describe)

Dentis I-FIX Abutment is intended for use as an aid in prosthetic rehabilitation.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

Submitter

Dentis Co., Ltd. EunJin, Shin 99, Seongseoseo-ro, Dalseo-gu Daegu, 42718 Korea Email: ej0616@dentis.co.kr Tel. +82-53-589-3646 Fax. +82-53-289-7922

Device Information

510(k) number: K230203
Trade Name: Dentis I-FIX Abutment ●
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: 05/03/2023 ●

Predicate Devices:

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

Primary Predicate

. K210826, Healing Abutment, Cover Screw manufactured by MegaGen Implant Co., Ltd.
Reference devices
K083586, I-FIX SYSTEM manufactured by Dentis Co., Ltd. ●
K111364, HAPTITE COATING IMPLANT SYSTEM by Dentis Co., Ltd.
K171027, Dentis Dental Implant System manufactured by Dentis Co., Ltd. ●

Indication for Use:

Dentis I-FIX Abutment is intended for use as an aid in prosthetic rehabilitation.

Device Description:

Dentis I-FIX Abutment consists of I-FIX Angled Type Fixture Healing Abutment, I-FIX Angled Type Fixture Healing Abutment Screw, and I-FIX Abutment Screw.

I-FIX Angled Type Fixture Healing Abutment and I-FIX Angled Type Fixture Healing Abutment Screw are compatible with following Implant Systems:

Proprietary Name	I-FIX System (Angled Type Fixture)
Compatible Implants (K number)	K083586
Implant diameter size	Ø 2.0, 2.5, 3.0 mm
Implant length	10~16 mm

I-FIX Abutment Screw is only used with I-FIX Cemented Abutment and I-FIX Free Abutment cleared in K083586.

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

{4}------------------------------------------------

The dimensions of abutments are as following:

No.	Device Name	Dimension (mm)	Angulation
1	I-FIX Angled Type FixtureHealing Abutment	(D) 4.03 X (L) 3.2, 4, 5 and 7	0°
2	I-FIX Angled Type FixtureHealing Abutment Screw	(D) 2.15 X (L) 4.0, 4.8, 6.1 and 8.0	0°
3	I-FIX Abutment Screw	(D) 2.15 X (L) 4.7	0°

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

The Abutments have below featured:

Name	Uses	Surface	Materials
I-FIX Angled Type Fixture HealingAbutment	The healing Abutment is used forprotecting inner hole of fixture and	Non	Titanium Grade 4
I-FIX Angled Type Fixture HealingAbutment Screw	adjusting the appropriate height during thehealing period	Non	Ti-6Al-4V ELI
I-FIX Abutment Screw	I-FIX Abutment screw is used with thepreviously cleared devices, K083586 suchas I-FIX Cemented and Free Abutment forconnecting with fixture.	Non	Ti-6Al-4V ELI

I-Fix Angled Type Fixture Healing Abutment and I-FIX Angled Type Fixture Healing Abutment Screw are packaged as a set and provided sterilized. I-FIX Abutment Screw is provided non-sterilized.

Materials

I-FIX Angled Type Fixture Healing Abutment is fabricated from pure titanium (Conforming to . ASTM Standard F67)
I-FIX Angled Type Fixture Healing Abutment Screw and I-FIX Abutment Screw are fabricated . from Ti-6Al-4V ELI (Conforming to ASTM Standard F136)

{5}------------------------------------------------

Summaries of Technological Characteristics & Substantial Equivalence Discussion

			I-FIX Angled Type Fixture Healing Abutment & I-FIX Angled Type Fixture Healing Abutment Screw
	Subject Device	Primary Predicate	Reference Device
K number	K230203	K210826	K171027
Manufacturer	Dentis Co., Ltd.	MegaGen Implant Co., Ltd.	Dentis Co., Ltd.
Device Name	Dentis I-FIX Abutment	Healing Abutment, Cover Screw	Dentis Dental Implant System
Model Name	I-FIX Angled Type Fixture Healing Abutment & I-FIX Angled Type Fixture Healing Abutment Screw	Healing Abutment & Scan Healing Abutment Screw	s-Clean Healing Abutment
Design	Image: I-FIX Angled Type Fixture Healing Abutment & I-FIX Angled Type Fixture Healing Abutment Screw	Image: Healing Abutment & Scan Healing Abutment Screw	Image: s-Clean Healing Abutment
Diameter	Ø 4.03 mm	Ø 4.0 ~ 10.0 mm	Ø 4.0, 4.5, 4.8, 5.0, 5.5, 6.0, 6.5, 7.0 and 7.5 mm
Cuff Length	0.8 mm	2.0~7.0 mm	1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5 mm
Male Screw x Pitch	M1.6 X 0.35P	M1.6 X 0.35PM1.8 X 0.35PM2.0 X 0.35P	M1.6 X 0.35P
Coating	Non	NonScrew: Anodizing	Non
Material	Body: CP Titanium Gr4 (ASTM F67)Screw: Ti-6Al-4V ELI (ASTM F136)	Ti-6Al-4V ELI (ASTM F136)	Titanium Gr4 (ASTM F67)
Indications for Use	Dentis I-FIX Abutment is intended for use as an aid in prosthetic rehabilitation.	MegaGen Prosthetics are intended for use as an aid in prosthetic rehabilitation.	Dentis Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including cemented retained, screw retained, or overdenture restorations. Dentis Dental Implant System serves as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants. This is an implant abutment support prosthesis such as the artificial teeth used temporarily for the restoration of masticatory function of patients.
Sterilization	Gamma sterile	Gamma sterile	Gamma sterile
Comparison	When comparing the subject device to the primary predicate, the indication for use, use with screw, Male Screw X Pitch, function, and coating are the same. The difference between two devices are material and dimensions. To support the difference of material, K171027 was added. The dimensions of subject device are slightly smaller than the identified predicate devices; however, this difference is not an important factor to device performance. Therefore, subject device and predicate device are substantially equivalent.

I-FIX Angled Type Fixture Healing Abutment & I-FIX Angled Type Fixture Healing Abutment Screw

{6}------------------------------------------------

I-FIX Abutment Screw

	Subject Device	Reference Device
K number	K230203	K083586
Manufacturer	Dentis Co., Ltd.	Dentis Co., Ltd.
Model Name	I-FIX Abutment Screw	s-Clean Abutment Screw
Design	Image: I-FIX Abutment Screw	Image: s-Clean Abutment Screw
Head Diameter	Ø 2.15 mm	Ø 2.2 mm
Length	4.7mm	4.05mm
Male Screw x Pitch	M1.6 X 0.35P	M1.6 X 0.35P
Coating	Non	Non
Material	Ti-6Al-4V ELI (ASTM F136)	Ti-6Al-4V ELI (ASTM F136)
Sterilization	End User Sterilization	End User Sterilization
Comparison	Subject Device and Reference Device have the same indications for use, function material,coating, and sterilization method. The Head diameter is different; however, this differenceis not an important factor to device performance. Therefore, subject device and predicatedevice are substantially equivalent.

Non-Clinical Test Data

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

Sterilization validation test on healing abutment made of Titanium Gr4 according to ISO . 11137-1,2,3 referenced in K210134
Sterilization validation test on healing abutment made of Ti-6A1-4A1 ELI according to ISO ● 11137-1,2,3
End User Sterilization Validation Test Report on Abutments according to ANSI/AAMI ST79, ● ISO 17665-1,-2, ISO 11737-1,-2, and ISO 11138-1 referenced in K111364
Shelf Life Test on Healing Abutment according to ASTM F1980 referenced in K171027
Biocompatibility testing according to ISO 10993-1:2009 for Pure Titanium Grade 4 or Ti-6Al-● 4V ELI referenced in K210134 and K16124

The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.

Non-clinical test data was conducted in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments". Clinical testing was not necessary to establish substantial equivalency of the device.

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 O., 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.

{7}------------------------------------------------

Conclusion

Dentis I-FIX 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, Dentis I-FIX 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.)