The Dentis Dental Implant System is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

Device Description

The Dentis Dental Implant System consists of three system, i-Clean System, s-Clean System, and e-Clean System. The purpose of this submission is to add various fixtures and abutment to the previously cleared device, K073486. Also, various set packing codes have been changed and it applies to the subject submission. Each system in the submission includes:

i-Clean System: Fixture (i-Clean Tapered Fixture/ i-Clean Straight Fixture / i-Clean Tapered II Fixture / i-Clean SAVE Fixture / i-Clean SAVE II Fixture), Abutment (i-Clean Cover Screw, i-Clean Closing Screw, i-Clean Solid Abutment, i-Clean Excellent Solid Abutment, i-Clean Healing Abutment, i-Clean Octa Abutment, i-Clean SynOcta Abutment, i-Clean InOcta Abutment, i-Clean Free Abutment, i-Clean Octa Healing Cap, i-Clean Gold UCLA, i-Clean Temporary Abutment, i-Clean Solid Healing Cap, i-Clean O-ring Abutment)
s-Clean System: Fixture (s-Clean Tapered Fixture/ s-Clean Straight Fixture / s-Clean SAVE Fixture / s-Clean SAVE II Fixture), Abutment (s-Clean Cover Screw, s-Clean Healing Abutment, s-Clean Free Healing Abutment, s-Clean Couple Abutment, s-Clean Free Abutment, s-Clean Sole Abutment, s-Clean Sub-Octa Abutment, s-Clean Gold UCLA Abutment, s-Clean Temporary Abutment, s-Clean Sole Healing cap, s-Clean O-Ring Abutment, s-Clean Abutment screw, s-Clean CCM UCLA Abutment)
e-Clean System: Fixture (e-Clean Tapered Fixture/ e-Clean Tapered II Fixture), Abutment (e-Clean Cover Screw, e-Clean Abutment Screw, e-Clean Mount Screw, e-Clean Healing Abutment ,e-Clean Cemented Abutment, e-Clean Gold UCLA Abutment, e-Clean Temporary Abutment(Ti), e-Clean O-Ring Abutment)
The surface of the fixture has been treated with RBM (Resorbable Blasted media).

AI/ML Overview

This document discusses the Dentis Dental Implant System and its substantial equivalence to previously cleared predicate devices. Since this is an unassisted device (a dental implant system), the concepts of "acceptance criteria for device performance," "test set," "training set," "experts for ground truth," "adjudication method," and "MRMC study" are not directly applicable in the way they would be for an AI/ML-driven device.

Instead, the "acceptance criteria" here relate to demonstrating that the new device (Dentis Dental Implant System with added fixtures and abutments) is as safe and effective as existing legally marketed devices. This is typically achieved through comparison to predicate devices and non-clinical testing.

Here's an interpretation of the requested information in the context of this unassisted medical device:

1. Table of Acceptance Criteria and the Reported Device Performance

For an unassisted device like this, "acceptance criteria" are not performance metrics in the sense of accuracy, sensitivity, or specificity. Instead, they are the criteria used to demonstrate substantial equivalence to a predicate device, as required for 510(k) clearance. These typically involve demonstrating equivalence in:

Intended Use: The purpose for which the device is used.
Technological Characteristics: How the device achieves its intended purpose (e.g., design, materials, surface treatment, sterilization, packaging, shelf life).
Performance Data: Non-clinical tests to confirm the device meets safety and functional requirements.

The reported device "performance" is therefore its adherence to these characteristics, demonstrating it is as safe and effective as the predicate.

Acceptance Criteria (Demonstration of Substantial Equivalence to Predicate K073486, K142313, K161244, K153639, K150344)	Reported Device Performance (Dentis Dental Implant System)
Intended Use Equivalence	The Dentis Dental Implant System's intended use is for surgical placement in upper and lower jaw arches to provide a root form for single or multiple-units prosthetic appliance attachment to restore chewing function. It supports conventional two-stage surgical processes (with option for transmucosal healing) and single-stage for immediate loading (with good primary stability and appropriate occlusal loading). This is stated to be substantially equivalent to the predicate devices.
Material Equivalence	Fixtures: CP Titanium Gr.4 for i-Clean, s-Clean, e-Clean systems. Abutments: Ti-6Al-4V ELI (Grade 5) or Pure Titanium (Grade 4) for most metal components, Acetal and Gold Alloy for others. The PEEK material used for s-Clean Temporary abutment is the same as the predicate (K150344). These materials were leveraged from previously cleared devices (K073486, K150344) and deemed biocompatible and substantially equivalent.
Surface Treatment Equivalence	RBM (Resorbable Blasted Media) for all fixtures. This is identical to the surface treatment of the primary predicate K073486.
Design/Dimension Equivalence (for new fixtures/abutments)	New fixtures (Straight, Tapered II, SAVE II designs with slightly different thread profiles and sizes, new diameter sizes for Tapered and SAVE designs) and abutments were added. Information from predicate K073486 was leveraged to show "worst case by comparing the measurements of proposed fixtures from each system," concluding that the additions do not raise risks or questions. Full tables of specific dimensions are provided in the submission (pages 4-5 and 10-17).
Sterilization Process Equivalence	Fixtures and Cover Screws/Healing Abutments supplied sterile by gamma sterilization. Abutments are provided separately and sterilized by the user. The sterilization method (gamma irradiation for sterile components, steam for user-sterilized) and standards (ISO 11137-1,-2,-3 for sterilization, ISO 17665-1,-2 for end-user sterilization) are stated to be identical to or leveraged from predicate devices (K073486, K161244).
Shelf Life Equivalence	Fixtures: 8 years (e.g., i-Clean system, s-Clean system, e-Clean system). This is longer than some primary predicates (2 years for K073486, 1 year for K153639) but supported by reference predicate K161244 (8 years). Healing Abutment: 8 years, supported by predicate K161244. Demonstrated through Shelf Life Validation Test according to ISO 11607-1, -2 and ASTM F1980-07 referenced in K153639 (fixtures) and K161244 (fixtures and healing abutment).
Biocompatibility	The PEEK material used for temporary abutments was tested based on ISO 10993-5:2009 (Cytotoxicity) and ISO 10993-10:2010 (Sensitization and Irritation), as referenced in predicate K150344. The materials (pure titanium, Ti-6Al-4V ELI) were previously cleared in K073486 and deemed biocompatible.
Endotoxin Content	Limulus amebocyte lysate (LAL) test performed for endotoxin sampling of devices labeled as sterile, in accordance with USP <85> and USP <161>, meeting criteria.
Other Non-Clinical Tests (Manufacturing Process, Device Dimensions, etc.)	The manufacturing process is stated to be identical (for PEEK material in temporary abutments). Dimensions are compared in detail to predicate devices for all new fixtures and abutments, with the conclusion that leveraged information from predicate K073486, and reference predicates K153639 and K161244, justified that different shapes and sizes do not raise any risks and questions.

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable in the context of an AI/ML device. For this unassisted medical device, "testing" refers to non-clinical bench testing (e.g., LAL, sterilization validation, shelf-life validation, biocompatibility) rather than a dataset for evaluating an algorithm's performance. The document doesn't specify the number of units or samples used for these non-clinical tests.
Data Provenance: The non-clinical tests were performed by Dentis Co., Ltd. (South Korea) or leveraged from prior submissions for their predicate devices. The tests adhere to international standards (e.g., ISO, ASTM, USP). The country of origin for the device is South Korea.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This concept is not applicable for this type of unassisted medical device. "Ground truth" established by experts is relevant for AI/ML diagnostic or prognostic devices where human experts define the correct diagnosis or outcome. For a dental implant system, the "ground truth" is typically defined by engineering specifications, material standards, and biological compatibility standards, evaluated through physical and chemical testing.

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

This concept is not applicable as there is no test set in the AI/ML sense, and no human interpretation requiring adjudication.

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

No MRMC study was done. This device is an implant system, not an AI-assisted diagnostic or interpretative tool that would involve human "readers."

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

This is not applicable as this is not an algorithm or AI device.

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

For this device, the "ground truth" is defined by established engineering and material standards, biological compatibility requirements (ISO 10993 series), and manufacturing process controls. The tests (e.g., LAL, sterilization, shelf life, biocompatibility) confirm that the device meets these pre-defined standards. There is no "ground truth" derived from expert consensus on medical images or patient outcomes data in the way an AI/ML device would use it.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. This is not an AI/ML device, so there is no "training set" or ground truth established for it.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

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

September 6, 2017

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

Re: K171027

Trade/Device Name: Dentis Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: July 31, 2017 Received: August 8, 2017

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 (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 Industry and Consumer Education (DICE) at its toll-free 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" (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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Andrew I. Steen -S

for Lori A. Wiggins, MPT, CLT 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K171027

Device Name Dentis Dental Implant System

Indications for Use (Describe)

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.

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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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Image /page/3/Picture/1 description: The image shows the logo for DENTIS. The logo features an orange swirl design on the left, followed by the word "DENTIS" in black, bold letters. The swirl design appears to be a stylized representation of a tooth or a dental-related symbol.

99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806

510(K) Summary

Submitter

Dentis Co., Ltd. Sun Chul Shin 99, Seongseoseo-ro, Dalseo-gu Daegu, 42718 South Korea Phone: +82-53-583-2804 Fax: +82-53-583-2806

Official Correspondent

Withus Group Inc. April Lee 2531 Pepperdale Drive Rowland Heights, CA 91748 USA Email: withus6664@gmail.com Phone: 909-274-9971 Fax: 909-460-8122

Device Information

Trade Name: Dentis Dental Implant System Common Name: Endosseous Dental Implant Classification Name: Endosseous Dental Implant Primary Product Code: DZE Secondary Product Code: NHA Regulation Number: 872.3640 Device Class: Class II Date Prepared: 9/5/2017

Description

1) i-Clean System

Fixture

i-Clean Tapered Fixture/ i-Clean Straight Fixture / i-Clean Tapered II Fixture / i-Clean SAVE Fixture / i-Clean SAVE II Fixture

Abutment

i-Clean Cover Screw, i-Clean Closing Screw, i-Clean Solid Abutment, i-Clean Excellent Solid Abutment, i-Clean Healing Abutment, i-Clean Octa Abutment, i-Clean SynOcta Abutment, i-Clean InOcta Abutment, i-Clean Free Abutment, i-Clean Octa Healing Cap, i-Clean Gold UCLA, i-Clean Temporary Abutment, i-Clean Solid Healing Cap, i-Clean O-ring Abutment

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Image /page/4/Picture/0 description: The image shows the logo for Dentis. The logo consists of an orange swirl on the left and the word "DENTIS" in black font on the right. The swirl is a gradient of orange, with the darkest shade at the bottom and the lightest shade at the top.

99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806

2) s-Clean System

Fixture

s-Clean Tapered Fixture/ s-Clean Straight Fixture / s-Clean SAVE Fixture / s-Clean SAVE II Fixture

Abutment

s-Clean Cover Screw, s-Clean Healing Abutment, s-Clean Free Healing Abutment, s-Clean Couple Abutment, s-Clean Free Abutment, s-Clean Sole Abutment, s-Clean Sub-Octa Abutment, s-Clean Gold UCLA Abutment, s-Clean Temporary Abutment, s-Clean Sole Healing cap, s-Clean O-Ring Abutment, s-Clean Abutment screw, s-Clean CCM UCLA Abutment

3) e-Clean System

Fixture

e-Clean Tapered Fixture/ e-Clean Tapered II Fixture

Abutment

e-Clean Cover Screw, e-Clean Abutment Screw, e-Clean Mount Screw, e-Clean Healing Abutment ,e-Clean Cemented Abutment, e-Clean Gold UCLA Abutment, e-Clean Temporary Abutment(Ti), e-Clean O-Ring Abutment

The surface of the fixture has been treated with RBM (Resorbable Blasted media).

The dimensions of the fixtures are below:

. i-Clean Tapered Fixture

Diameter	Length
Ø 3.7 mm	8, 10, 12, 14 mm
Ø 4.1mm	8, 10, 12, 14 mm
Ø 4.3mm	8, 10, 12, 14 mm
Ø 4.7mm	8, 10, 12, 14 mm

. i-Clean Straight Fixture

Diameter	Length
Ø 4.05 mm	8, 10, 12, 14mm
Ø 4.25mm	8, 10, 12, 14mm
Ø 4.75mm	8, 10, 12, 14mm

● i-Clean Tapered II Fixture

Diameter	Length
Ø 3.7 mm	8, 10, 12, 14 mm
Ø 4.1 mm	8, 10, 12, 14 mm
Ø 4.3 mm	8, 10, 12, 14 mm
Ø 4.7 mm	8, 10, 12, 14 mm

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Image /page/5/Picture/0 description: The image contains the word "DENTIS" in a bold, sans-serif font. To the left of the word is an orange graphic. The graphic appears to be a stylized flame or abstract shape, with a gradient from a darker orange at the base to a lighter orange at the tip.

99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806

i-Clean SAVE Fixture .

Diameter	Length
Ø 5.5mm	7, 8, 9, 10, 12 mm
Ø 6.0mm	7, 8, 9, 10, 12 mm

i-Clean SAVE II Fixture .

Diameter	Length
Ø 5.5mm	7, 8, 10, 12 mm
Ø 6.0mm	7, 8, 10, 12 mm

s-Clean Tapered Fixture

Diameter	Length
Ø 3.7 mm	8, 10, 12, 14 mm
Ø 4.1mm	8, 10, 12, 14 mm
Ø 4.3mm	8, 10, 12, 14 mm
Ø 4.8mm	8, 10, 12, 14 mm

. s-Clean Straight Fixture

Diameter	Length
Ø 4.1mm	8, 10, 12, 14, 16 mm
Ø 4.3mm	8, 10, 12, 14, 16 mm
Ø 4.75mm	8, 10, 12, 14, 16 mm

● s-Clean SAVE Fixture

Diameter	Length
Ø 5.5mm	7, 8, 9, 10, 12 mm
Ø 6.0mm	7, 8, 9, 10, 12 mm

. s-Clean SAVE II Fixture

Diameter	Length
Ø 5.5mm	7, 8, 9, 10, 12 mm
Ø 6.0mm	7, 8, 9, 10, 12 mm

. e-Clean Tapered Fixture

Diameter	Length
Ø 3.5mm	8, 10, 12, 14 mm
Ø 4.1mm	8, 10, 12, 14 mm
Ø 5.1mm	8, 10, 12, 14 mm

e-Clean Tapered II Fixture .

Diameter	Length
Ø3.5mm	8, 10, 12, 14 mm
Ø4.1mm	8, 10, 12, 14 mm
Ø5.1mm	8, 10, 12, 14 mm

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99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806

The packaging has composed of fixture with cover screw. The fixtures, cover screws and healing abutments are supplied sterile by gamma sterilization. The fixtures are provided as set-packing with the cover screws. The abutments are provided separately and should be sterilized by user before use.

Indication for Use

Predicate Devices & Comparison

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

. K073486, Dentis Dental Implant System by Dentis Co., Ltd. - Primary predicate
K142313, OneQ-SL s-Clean Implant System by Dentis Co., Ltd. ●
K161244, s-Clean OneQ-SL Narrow System by Dentis Co., Ltd. .

1 Fixtures

a. i-Clean System

a.	Subject device	Primary Predicate device	Reference Predicate Device	Reference Predicate Device
Device name	Dentis DentalImplant System	Dentis DentalImplant System	OneQ-SL s-CleanImplant System	s-Clean OneQ-SLNarrow ImplantSystem
510(k) number	NA	K073486	K142313	K161244
Manufacturer	Dentis Co., Ltd.	Dentis Co., Ltd.	Dentis Co., Ltd.	Dentis Co., Ltd.
Intended use	The DentisDental ImplantSystem is anendosseousdental implantthat is indicatedfor surgicalplacement inthe upper andlower jawarches, toprovide a rootform means forsingle ormultiple-unitsprostheticappliance	The Dentis DentalImplant System is anendosseous dentalimplant is indicatedfor surgical placementin the upper and lowerjaw arches, to providea root form means forsingle or multiple-units prostheticappliance attachmentto restore a patient'schewing function.Implants can beplaced with aconventional two	The OneQ-SLImplant System isindicated for use inpartially or fullyedentulous mandiblesand maxillae, insupport of single ormultiple-unitrestorations including;cemented retained,screw retained, oroverdenturerestorations, andterminal orintermediate abutmentsupport for fixedbridgework. Thissystem is dedicated	The s-Clean OneQ-SL Narrow ImplantSystem (3.0,3.3mm) may beused as an artificialroot structure forsingle toothreplacement ofmandibular centraland lateral incisorsand maxillarylateral incisors.The implants maybe restoredimmediately1) with a temporaryprosthesis that is

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Image /page/7/Picture/0 description: The image contains the word "DENTIS" in bold, black letters. To the left of the word is an orange graphic that resembles a flame or a stylized letter "D". The graphic is a gradient, with the color transitioning from a lighter orange at the top to a darker orange at the bottom.

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9 - Dentis Co., Ltd.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea
2806 - Tel : 82.53.582.2804 /Fax : 82.53.583.2806

Gamma sterilized	Yes	Yes	Yes	Yes
Product Code	DZE, NHA	DZE, NHA	DZE, NHA	DZE, NHA
Shelf Life	8 years	2 years	1 years	8 years
Brief Comparison	Similarities: The subject device has equivalent indications for use, material,surface treatment, dimension, sterilization, and shelf life as predicate devices.Differences: New fixtures added to include Straight, Tapered II, and SAVE IIdesigns that have slightly different thread profiles and sizes; new diameter sizesadded for Tapered (Ø 4.1, 4.7mm) and SAVE (Ø 5.5, 6.0mm) designs. Allfixtures with new co-packaging to include Cover Screw. With different shapesand sizes added, leveraged information from fixtures in predicate (K073486)justified to show worst case by comparing the measurements of proposed fixturesfrom each system. Therefore, addition of fixtures does not raise any risks andquestions. The reference predicates, s-Clean OneQ-SL Narrow Implant System(K161244), supports substantial equivalence of shelf life.

b. s-Clean System

	Subject device	Predicate device	Reference Predicate Device	Reference Predicate Device
Device name	Dentis Dental Implant System	Dentis Dental Implant System	OneQ-SL s-Clean Implant System	s-Clean OneQ-SL Narrow Implant System
510(k) number	NA	K073486	K153639	K161244
Manufacturer	Dentis Co., Ltd.	Dentis Co., Ltd.	Dentis Co., Ltd.	Dentis Co., Ltd.
Intended use	The Dentis Dental Implant System is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient's chewing	The Dentis Dental Implant System is an endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate	The OneQ-SL s-Clean 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, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading	The s-Clean OneQ-SL Narrow Implant System (3.0, 3.3mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implants may be restored immediately 1) with a temporary prosthesis that is not in functional occlusion, 2) when splinted together as an
	function.	loading. Immediate		artificial root
	Implants can be	loading is restricted to		structure for
	placed with a	the anterior mandible		multiple tooth
	conventional	based on four splinted		replacement of
	two stage	Interforaminal placed		mandibular
	surgical process	implants.		incisors, or
	with an option			3) for denture
	for			stabilization using
	transmucosal			multiple implants
				in the anterior
	healing or they			mandible andmaxilla.
	can be placed in			The implants may
	a single stage
	surgical process			be placed in
	for immediate			immediate
	loading when			function when
	good primary			good primary
	stability has			stability has been
	been achieved			achieved and with
	and with			appropriate occlusal
	appropriate			loading.
	occlusal
	loading.

Material	CP Titanium Gr.4	CP Titanium Gr.4	CP Titanium Gr.4	Ti-6Al-4V ELI
	Tapered, SAVE,	- Tapered: Internal		Straight and
	Straight, and	Hex connected,		tapered implant
		Submerged, micro-	• Internal Hex-connected	body
	SAVE II	thread design		3 sided cutting
Design	designs, eachInternal Hexconnected	- SAVE: Abutmentwith connection of11° morse tapershape, micro-threaddesign	• Bone level• Tapered &straight body	• edge of bottom• Internal doublehex connection• Bone leveldesign.
Fixture diameter(Ø)	3.7, 4.1, 4.3,4.8, 5.5, 6.0mm	3.5, 3.7, 4.1, 4.3, 4.8,5.5, 6.0mm	3.7, 3.9, 4.2, 4.7,5.2, 6.0, 7.0, 7.0 mm	3.0, 3.3 mm
Fixture length	7, 8, 9, 10, 12,14 mm	7, 8, 10, 12, 14 mm	7, 8, 10 ,12, 14 mm	10 ,12, 14 mm
Surfacetreatment	RBM	RBM	SLA	SLA
Gammasterilized	Yes	Yes	Yes	Yes
Product Code	DZE, NHA	DZE, NHA	DZE, NHA	DZE, NHA

Shelf Life	8 years	2 years	1 years	8 years

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Image /page/9/Picture/0 description: The image shows the word "DENTIS" in bold, black letters. To the left of the word is an orange, abstract symbol that resembles a flame or a stylized letter 'J'. The symbol is composed of curved lines that create a sense of movement and energy. The overall design is clean and modern, suggesting a professional and innovative company.

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Image /page/10/Picture/0 description: The image shows the word "DENTIS" in bold, black font. To the left of the word is an orange swirl design. The swirl is made up of two curved lines that start at a single point and then separate, with one line curving around the other.

99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea

BriefComparison	Similarities: The subject device has equivalent indications for use, material,surface treatment, dimension, sterilization, and shelf life as predicate devices.Differences: New fixtures added to include Straight and SAVE II designs thathave slightly different thread profiles and sizes; new diameter sizes added forTapered (Ø 4.1mm) and SAVE (Ø 5.5mm) designs. All fixtures with new co-packaging to include Cover Screw. With different shapes and sizes added,leveraged information from fixtures in predicate (K073486) justified to showworst case by comparing the measurements of proposed fixtures from eachsystem. Therefore, addition of fixtures does not raise any risks and questions. Thereference predicates, s-Clean OneQ-SL Narrow Implant System (K161244),supports substantial equivalence of shelf life.
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BriefComparison

Similarities: The subject device has equivalent indications for use, material,surface treatment, dimension, sterilization, and shelf life as predicate devices.Differences: New fixtures added to include Straight and SAVE II designs thathave slightly different thread profiles and sizes; new diameter sizes added forTapered (Ø 4.1mm) and SAVE (Ø 5.5mm) designs. All fixtures with new co-packaging to include Cover Screw. With different shapes and sizes added,leveraged information from fixtures in predicate (K073486) justified to showworst case by comparing the measurements of proposed fixtures from eachsystem. Therefore, addition of fixtures does not raise any risks and questions. Thereference predicates, s-Clean OneQ-SL Narrow Implant System (K161244),supports substantial equivalence of shelf life.

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c. e-Clean System

	Subject device	Predicate device	Reference Predicate Device	Reference Predicate Device
Device name	Dentis DentalImplant System	Dentis DentalImplant System	OneQ-SL s-Clean ImplantSystem	s-Clean OneQ-SLNarrow ImplantSystem
510(k) number	NA	K073486	K153639	K161244
Manufacturer	Dentis Co., Ltd.	Dentis Co., Ltd.	Dentis Co., Ltd.	Dentis Co., Ltd.
Intended use	The Dentis DentalImplant System isan endosseousdental implant thatis indicated forsurgical placementin the upper andlower jaw arches, toprovide a root formmeans for single ormultiple-unitsprosthetic applianceattachment torestore a patient'schewing function.Implants can beplaced with aconventional twostage surgicalprocess with anoption fortransmucosalhealing or they canbe placed in a singlestage surgicalprocess forimmediate loadingwhen good primarystability has been	DENTIS implantis designed foruse in edentuloussites in themandible ormaxilla forsupport for acomplete dentureprosthesis,terminal orintermediateabutment forfixed bridgework,partial dentures,or single toothreplacements.	The OneQ-SL s-Clean ImplantSystem is indicatedfor use in partially orfully edentulousmandibles andmaxillae, in supportof single or multipleunit restorationsincluding; cementedretained, screwretained, oroverdenturerestorations, andterminal orintermediateabutment support forfixed bridgework.This system isdedicated for one andtwo stage surgicalprocedures. Thissystem is intended fordelayed loading.	The s-Clean OneQ-SL Narrow ImplantSystem (3.0, 3.3mm)may be used as anartificial rootstructure for singletooth replacement ofmandibular centraland lateral incisorsand maxillary lateralincisors.The implants may berestoredimmediately1) with a temporaryprosthesis that is notin functionalocclusion,2) when splintedtogether as anartificial rootstructure formultiple toothreplacement ofmandibular incisors,or3) for denturestabilization usingmultiple implants inthe anterior mandibleand maxilla.
	achieved and withappropriate occlusalloading.			The implants may beplaced in immediatefunction whengood primary stabilityhas been achieved andwith appropriateocclusal loading.
Material	CP Titanium Gr.4	Commerciallypure titaniumGR.4 (ASTM-F-67)	CP Titanium Gr.4	Ti-6Al-4V ELI
Design	Tapered andTapered IIdesigns, eachExternal Hexconnected	Internal Hexconnected,Submerged,External Hexconnected	• Internal Hex-connected• Bone level• Tapered &straight body	• Straight and taperedimplant body• 3 sided cutting edgeof bottom• Internal double hexconnection• Bone level design.
Fixture diameter(Ø)	3.5, 4.1, 5.1mm	3.3, 3.5, 4.1,5.1mm	3.7, 3.9, 4.2, 4.7,5.2 mm	3.0, 3.3 mm
Fixture length	8, 10, 12, 14 mm	8, 10, 12, 14 mm	7, 8, 10 ,12, 14 mm	10 ,12, 14 mm
Surfacetreatment	RBM	RBM	SLA	SLA
Gammasterilized	Yes	Yes	Yes	Yes
Product Code	DZE, NHA	DZE, NHA	DZE, NHA	DZE, NHA
Shelf Life	8 years	2 years	1 years	8 years
BriefComparison	- Similarities: The subject device has equivalent indications for use, material,surface treatment, dimension, sterilization, and shelf life as predicate devices.- Differences: New fixture added to include Tapered II design that has slightlydifferent tread profiles and sizes. All fixtures with new co-packaging to includeCover Screw or Cover Screw with Mount and Mount Screw. With differentshapes and sizes added, leveraged information from fixtures in predicate(K073486) justified to show worst case by comparing the measurements ofproposed fixtures from each system. Therefore, addition of fixtures does not raiseany risks and questions. The reference predicates, s-Clean OneQ-SL NarrowImplant System (K161244), supports substantial equivalence of shelf life.
	Subject device	Primary Predicate	Reference Predicate
510(k) number	NA	K073486	K161244
Product Name	Solid Abutment	Solid Abutment	-
Dimension	Ø3.5 mm (D) x8, 9, 10.5, 12mm (L)	Ø3.5 mm (D) x9, 10.5, 12 mm (Length)	-
Material	Ti-6Al-4V ELI(Grade 5)	Ti-6Al-4V ELI(Grade 5)	-
Product Name	Excellent SolidAbutment	Excellent Solid Abutment	-
Dimension	Ø4.3 mm (D) x7.88, 8.78, 10.38, 11.88mm(L)	Ø4.3 mm (D) x8.78, 10.38, 11.88mm (L)	-
Material	Ti-6Al-4V ELI(Grade 5)	Ti-6Al-4V ELI(Grade 5)	-
Product Name	Octa Abutment	Octa Abutment	-
Dimension	Ø3.5, 4.3mm (D) x 7, 7.3mm(L)	Ø3.5mm (D) x 7mm (L)	-
Material	Ti-6Al-4V ELI(Grade 5)	Ti-6Al-4V ELI(Grade 5)	-
Product Name	SynOcta Abutment	SynOcta Abutment	-
Dimension	Ø3.5mm (D) x 8.3 mm (L)	Ø3.5mm (D) x 8.3 mm (L)	-
Material	Pure Titanium (Grade 4)	Pure Titanium (Grade 4)	-
Product Name	Healing Abutment	Healing Abutment	Healing Abutment
Dimension	Ø5.5, 6.4, 6.9mm(D) x7.1, 8.1, 8.3, 9.1, 9.3 9.6,10.6, 10.8 12.1mm(L)	Ø5.5, 6.4, 6.9mm(D) x8.1, 9.1, 10.6mm(L)	Ø4.0 mm(D) x7.9, 8.4, 8.9, 9.4, 9.9,10.4,10.9,11.4mm(L)
Material	Pure Titanium (Grade 4)	Pure Titanium (Grade 4)	Pure Titanium (Grade 4)
Product Name	InOcta Abutment	InOcta Abutment	-
Dimension	Ø5.2, 6.9 mm (D) x8.75, 9.75, 10.75, 11.75,8.85, 9.85, 10.85, 11.85 mm(L)	Ø5.2mm (D) x8.75, 9.75, 10.75,11.75mm (L)	-
Material	Pure Titanium (Grade 4)	Pure Titanium (Grade 4)	-
Product Name	TemporaryAbutment	Temporary Abutment	Temporary Abutment
Dimension	Ø5.0, 5.2, 6.8 6.9 mm (D) x11.5 12.75, 13.75, 14.75,15.75, 12.85, 13.85, 14.85,15.85 mm (L)	Ø5.0 5.2 mm (-D) x 11.512.75, 13.75, -14.75 mm(L)	Ø 4.0 mm (D) x 12.5and 13 mm (L)
Material	Pure Titanium (Grade 4)	Pure Titanium (Grade 4)	Pure Titanium (Grade 4)
Product Name	Octa Healing Cap	Octa Healing Cap	-
Dimension	Ø4.9, 6.6mm (D) x 4.0, 4.3mm (L)	Ø4.9mm (D) x 4.0 mm (L)	-
Material	Acetal, Pure Titanium(Grade 4)	Acetal, Pure Titanium(Grade 4)	-
Product Name	Gold UCLAAbutment	Gold UCLA Abutment	Gold UCLA Abutment
Dimension	Ø5.0, 5.1, 6.8 mm (D) x14.25, 14.3, 14.65, 14.7,15.6mm (L)	Ø5.0, 5.1mm (D) x14.3,14.7mm (L)	Ø 4.0 mm (D) x 14.5and 15 mm (L)
Material	Gold Alloy, Acetal	Gold Alloy, Acetal	Gold Alloy, Acetal
Product Name	Solid Healing Cap	Solid Healing Cap	Healing Cap
Dimension	Ø5.4, 5.5, 5.9, 7mm (D) x4.7, 5.5, 6.4, 6.5, 8.0, 9.4,9.5mm (L)	Ø5.5, 5.9 mm (D) x4, 5.5, 7mm (L)	Ø 4.6 mm (D) x 6, 7.5and 9 mm (L)
Material	Acetal	Acetal	Acetal
Product Name	O-ring Abutment	O-ring Abutment	O-ring Abutment
Dimension	Ø3.5, 4.3mm (D) x 9.1, 9.4,11.1, 11.4, 13.1, 13.4 mm(L)	Ø3.5mm (D) x9.1,11.1,13.1mm (L)	Ø 3.5 mm (D) x 10 and12 mm (L)
Material	Ti-6Al-4V ELI(Grade 5)	Ti-6Al-4V ELI(Grade 5)	Ti-6Al-4V ELI(Grade 5)
Sterilization	Steam sterilization by user	Steam sterilization by user	Steam sterilization byuser
Product Code	NHA	NHA	NHA
Shelf Life ofHealing Abutment	8 years	5 years	8 years
Sterilizationmethod forHealing abutment	Gamma Irradiation	Gamma Irradiation	Gamma Irradiation
Brief Comparison	The reference predicates, s-Clean OneQ-SL Narrow Implant System (K161244)supports substantial equivalence of shelf life of healing abutment.
	Subject device	Primary Predicate	Reference Predicate
510(k) number	NA	K073486	K161244
Product Name	Healing Abutment	Healing Abutment	Healing Abutment
Dimension	Ø 4.0, 4.5, 4.8, 5.0, 5.5, 6.0,6.5,7.0, 7.5mm (D) X 9.5, 10.0, 10.5, 11.0, 11.5, 12.0, 12.5, 13.0, 13.5, 14.0 mm (L)	Ø 4.5, 5.0, 5.5, 6.0, 6.5,7.0mm (D) X 9.5, 10.0, 10.5, 11.0, 12.0, 13.0, 13.5, 14.0 mm (L)	Ø4.0 mm(D) x 7.9, 8.4, 8.9, 9.4, 9.9, 10.4,10.9,11.4mm(L)
Material	Pure Titanium (Grade 4)	Pure Titanium (Grade 4)	Pure Titanium (Grade 4)
Product Name	Free Healing Abutment	Free Healing Abutment	-
Dimension	Ø 4.0, 4.5, 5.5, 6.5mm(D) x 8.8, 9.3, 10.8, 11.3mm(L)	Ø 4.5, 5.5mm(D) x 9.3,11.3mm(L)	-
Material	Pure Titanium (Grade 4)	Pure Titanium (Grade 4)	-
Product Name	Sole Abutment Healing Cap	Sole Abutment Healing Cap	-
Dimension	Ø5.1, 5.8, 6.3, 6.8mm (D) x 7 mm (L)	Ø4.5, 5.5, 6.5mm(D) x 7mm(L)	-
Material	Ti-6Al-4V ELI(Grade 5)	Ti-6Al-4V ELI(Grade 5)	-
Product Name	Sole Abutment	Sole Abutment	Sole Abutment
Dimension	Ø4.5, 4.8, 5.5, 6.0, 6.5 mm (D) x 12.5, 13.0, 13.5, 14,15, 16, 17 mm (L)	Ø4.5, 5.5, 6.5 x 0.8, 1.5, 2.0, 2.5, 3.5, 4.5, 5.5mm(Cuff)	Ø 4.0 mm (D) x 9.4, 10.4, 10.9, 11.9, 12.4, 12.9, 13.4, 14.4, 14.9, 15.9 mm (L)
Material	Ti-6Al-4V ELI(Grade 5)	Ti-6Al-4V ELI(Grade 5)	Ti-6Al-4V ELI(Grade 5)
Product Name	Couple Abutment	Couple Abutment	-
Dimension	Ø4.0, 4.5, 4.8, 5.5, 6.0, 6.5 mm (D) x 7.3, 7.44, 7.8, 7.94, 8.3, 8.44, 8.94, 8.8, 8.94, 9.3, 9.44, 9.8, 9.94, 10.3, 10.94, 10.44, 10.8, 10.94, 11.3,11.44, 11.8, 11.94, 12.3, 12.44,12.8, 12.94, 13.8, 13.3, 13.44, 13.94, 14.8, 14.94 mm (L)	Ø4.5,5.5, 6.5mm (D) x 1.0, 1.5, 2.0,2.5, 3.5, 4.5, 5.5 mm (Cuff)	-
Material	Ti-6Al-4V ELI(Grade 5)	Ti-6Al-4V ELI(Grade 5)	-
Product Name	O-Ring Abutment	O-Ring Abutment	O-Ring Abutment
Dimension	Ø3.4, 4.5mm (D) x10.1, 11.6, 13.6 mm (L)	Ø3.4, 4.5mm(D) x 0.5, 2,4mm(Cuff)	Ø 3.5 mm (D) x 10, 12mm (L)
Material	Ti-6Al-4V ELI(Grade 5)		Ti-6Al-4V ELI (Grade 5)
Product Name	Sub-Octa Abutment	Sub-Octa Abutment	-
Dimension	Ø4.8mm (D) x 9.15, 9.65,10.65, 11.65, 12.65, 13.65mm (L)	Ø4.8mm(D) x 1.0, 1.5,2.5, 3.5, 4.5, 5.5mm (Cuff)
Material	Ti-6Al-4V ELI(Grade 5)		-
Product Name	Abutment screw	Abutment screw	Abutment screw
Dimension	Ø2.32mm (D) x 8.8, 9.2, 9.4,9.8, 9.95, 10.5 mm (L)	Ø2.32mm(D) x 9.8mm(L)	Ø 2.03 mm (D) x 9 mm(L)
Material	Ti-6Al-4V ELI(Grade 5)		Ti-6Al-4V ELI(Grade 5)
Product Name	Temporary Abutment	Temporary Abutment	Temporary Abutment
Dimension	Ø4.5, 4.8, 5.5, 6.0, 6.5mm(D) x 13.54, 13.4 mm (L)	Ø4.5, 5.5, 6.5mm(D) x13.54, 13.4mm (L)	Ø 4.0 mm (D) x 12.5and 13 mm (L)
Material	Pure Titanium (Grade 4)	Pure Titanium (Grade 4)	Pure Titanium (Grade 4)
Product Name	Gold UCLA Abutment	Gold UCLA Abutment	Gold UCLA Abutment
Dimension	Ø4.5 mm (D) x 15.34, 15.4mm (L)	Ø4.5 mm (D) x 15.34,15.4 mm (L)	Ø 4.0 mm (D) x 14.5, 15mm (L)
Material	Gold Alloy, Acetal	Gold Alloy, Acetal	Gold Alloy, Acetal
Product Name	CCM Abutment	-	CCM Abutment
Dimension	Ø4.5 mm (D) x 15.39, 15.44mm (L)		Ø 4.0 mm (D) x 14.5, 15mm (L)
Material	Co-Cr-Mo Alloy	-	Co-Cr-Mo Alloy
Sterilization	Steam sterilization by user	Steam sterilization by user	Steam sterilization byuser
Product Code	NHA	NHA	NHA
Shelf Life ofHealing Abutment	8 years	5 years	8 years
Sterilizationmethod forHealing abutment	Gamma Irradiation	Gamma Irradiation	Gamma Irradiation
Brief Comparison	The reference predicates, s-Clean OneQ-SL Narrow Implant System (K161244)supports substantial equivalence of shelf life.

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Image /page/11/Picture/0 description: The image contains the word "DENTIS" in bold, black font. To the left of the word is an orange graphic. The graphic is a circle with an orange swirl around it. The swirl starts thin and gets thicker as it goes around the circle.

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Image /page/12/Picture/0 description: The image contains the word "DENTIS" in bold, sans-serif font. To the left of the word is an orange, abstract logo. The logo appears to be a stylized, curved shape, possibly representing a flame or a stylized letter. The overall impression is a corporate logo for a company named Dentis.

99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea

② Abutment

a. i-Clean System

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Image /page/13/Picture/0 description: The image shows the word "DENTIS" in bold, black letters. To the left of the word is an orange graphic that resembles a flame or a stylized letter "D". The graphic is a gradient of orange, with the darkest shade at the bottom and the lightest at the top.

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Image /page/14/Picture/0 description: The image contains the word "DENTIS" in bold, black font. To the left of the word is an orange graphic that resembles a swirl. The graphic is lighter at the top and darker at the bottom.

b. s-Clean System

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Image /page/15/Picture/0 description: The image contains the word "DENTIS" in bold, sans-serif font. To the left of the word is an orange graphic that resembles a curved flame or a stylized letter 'D'. The overall impression is that of a company logo or brand name.

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Image /page/16/Picture/0 description: The image shows the word "DENTIS" with a stylized orange swirl to the left of the word. The word "DENTIS" is written in a bold, sans-serif font. The swirl is a gradient of orange, with the darker shades at the bottom and lighter shades at the top. The image is likely a logo for a dental company or organization.

99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea

	Subject Device	Previously Cleared Product
510(K) Number	K171027	K150344
Manufacturer	Dentis Co., Ltd	Dentis Co., Ltd.
Device Name	Dentis Dental Implant System	Dentis Dental Implant System
Model Name	Temporary Abutment	MU Click Bridge Cap
ManufacturingProcess	Identical	Identical
Materials	Identical	PEEK (Polyether ether ketone)
Body contact	Identical	Direct (Mucosal Membrane)
Contact Duration	Identical	Class B (> 24hr, <30 days )
Brief Comparison	The Peek material used for the subject device and predicate device (K150344) is exactlysame from same manufacturer. We provided the full biocompatibility test report of thePeek material in K150344. The test reports support substantial equivalences becausesame manufacturing process and material are used for subject and predicate devices.

s-Clean Temporary abutment made of PEEK material -

c. e-Clean System

	Subject device	Primary Predicate	Reference Predicate
510(k) number	NA	K073486	K161244
Product Name	Healing Abutment	Healing Abutment	Healing Abutment
Dimension	Ø4.0, 5.0, 6.0, mm (D) x7.4, 8.4, 9.4, 10.9, 12.4 mm(L)	Ø4.0, 5.0, 6.0mm(D) x2.0, 4.0, 5.5, 7.0mm(Cuff)	Ø4.0 mm(D) x7.9, 8.4, 8.9, 9.4, 9.9,10.4,10.9,11.4mm(L)
Material	Pure Titanium (Grade 4)	Pure Titanium (Grade 4)	Pure Titanium (Grade 4)
Product Name	CementedAbutment	Cemented Abutment
Dimension	Ø4, 5, 6 mm (D) x7, 8, 9, 10, 11, 12 mm (L)	Ø4, 5, 6mm(D) x6, 8mm(L)
Material	Pure Titanium (Grade 4)	Pure Titanium (Grade 4)
Product Name	Gold UCLAAbutment	Gold UCLA Abutment	Gold UCLA Abutment
Dimension	Ø4, 4.5, 5.5, mm (D) x13.2 mm (L)	Ø4, 4.5, 5.5, mm (D) x13.2 mm (L)	Ø4.0 mm (D) x 14.5and 15 mm (L)
Material	Gold Alloy, Acetal	Gold Alloy, Acetal	Gold Alloy, Acetal
Product Name	TemporaryAbutment	Temporary Abutment	Temporary Abutment
Dimension	Ø4, 4.5, 5.5, mm (D) x 12mm (L)	Ø4, 4.5, 5.5, mm (D) x12 mm (L)	Ø4.0 mm (D) x 12.5and 13 mm (L)

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Image /page/17/Picture/0 description: The image shows the logo for DENTIS. The logo consists of an orange swirl on the left and the word "DENTIS" in black, bold letters on the right. The swirl is a gradient of orange, with the top being a lighter shade and the bottom being a darker shade.

99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806

Material	Pure Titanium (Grade 4)	Pure Titanium (Grade 4)	Pure Titanium (Grade 4)
Product Name	O-ring Abutment	O-ring Abutment	O-ring Abutment
Dimension	Ø5,6mm (D) x 10.2, 12.2mm (L)	Ø5,6mm (D) x 10.2, 12.2mm (L)	Ø 3.5 mm (D) x 10 and12 mm (L)
Material	Ti-6A1-4V ELI(Grade 5)	Ti-6A1-4V ELI(Grade 5)	Ti-6A1-4V ELI(Grade 5)
Sterilization	Steam sterilization by user	Steam sterilization byuser	Steam sterilization by user
Product Code	NHA	NHA	NHA
Shelf Life of Healing Abutment	8 years	5 years	8 years
Sterilizationmethod for Healingabutment	Gamma Irradiation	Gamma Irradiation	Gamma Irradiation
Brief Comparison	The reference predicates, s-Clean OneQ-SL Narrow Implant System (K161244)supports substantial equivalence of shelf life.

Substantial Equivalence Discussion

The Dentis Dental Implant System has a substantially equivalent intended use as the identified predicate. The subject device is identical in fundamental scientific technology to the predicate device in that they all have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant Abutments, and they are all constructed of titanium.

The subject and predicate devices are identical in indication for use, material, connection structure, packaging, function, using abutments, performance, design, technology and dimensions. The subject device is the modification to the predicate, K073486 by adding various sizes of fixtures and abutments and new set codes.

Non-Clinical Test Data

The following test was performed for this subject system:

Limulus amebocyte lysate (LAL) test plan for endotoxin sampling of devices labeled as sterile, . in accordance with USP <85> and USP <161>
Below tests were performed for predicate devices and leveraged for the subject device:
Biocompatibility Tests for PEEK material based on ISO 10993-5:2009 (Cytotoxicity), ISO 10993-10:2010 (Sensitization and Irritation) referenced in K150344
. Sterilization Test according to ISO 11137-1,-2,-3 referenced in K073486
End user sterilization test according to ISO 17665-1, -2 referenced in K161244 ●
. Shelf life Validation Test according to ISO 11607-1. -2. and ASTM F1980-07 referenced in K153639 (Fixtures) and K161244 (Fixtures and Healing Abutment)

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

The fixture materials of the pure titanium and Ti-6Al-4V ELI are biocompatible because both materials were cleared in K073486 and it demonstrates substantial equivalence of materials.

The Peek material used for the subject device and predicate device (K150344) is exactly same from same manufacturer. We provided the full biocompatibility test report of the Peek material in K150344. The test

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Image /page/18/Picture/0 description: The image shows the logo for DENTIS. The logo consists of an orange swirl shape on the left, followed by the word "DENTIS" in bold, black letters. The swirl shape appears to be a stylized representation of a tooth or a dental instrument.

99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806

reports support substantial equivalences because same manufacturing process and material are used for subject and predicate devices.

The sterilization validation test was performed for predicate device, K073486 and leveraged for the subject device because the sterilization method, standard, facility, and SAL are exactly same. The RBM surface characterization was provided in the predicate device, K073486 according to "Guidance for FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant Abutments and it is exactly same for the subject device. The reference predicates, OneQ SL s-Clean Implant System (K153639) and s-Clean OneQ-SL Narrow Implant System (K161244), supports substantial equivalence of shelf life.

Summary of clinical testing

No clinical testing was performed for this submission.

Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Dentis Co., Ltd. Concludes that the Dentis Dental Implant System is substantially equivalent to the predicate devices as described herein

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.