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.

Device Description

The OneQ-SL s-Clean Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. This implant system has internal hex connection, tapered with straight body, bone level and submerged type that are similar to other commercial available products based on the intended use, technology used, the claims, the material composition employed and performance characteristics. This implant system is supplied sterile. The OneQ-SL s-Clean Implant system is substantially equivalent in connection structure, similar design, function and intended use to the predicate device, OneQ-SL s-Clean Implant System (K153639). This subject device is compatible with the abutments of K073486, K082843, K111364 and K150344. The fixture is made of Ti-6A1-4V ELI and Pure Titanium Grade 4. The Cover screw was cleared in K073486. The surface is treated by Sand -blasting (Large grit) and acid etching method (SLA). This system only contains the implant bodies with cover screw and are provided as set-packing. The purpose of this submission is to add new fixtures.

AI/ML Overview

This appears to be a 510(k) premarket notification for a medical device, specifically an endosseous dental implant system. The document states that the device, "OneQ-SL s-Clean Implant System," is substantially equivalent to legally marketed predicate devices, and therefore no new clinical studies are presented within this document to prove acceptance criteria through device performance.

The document does not describe acceptance criteria for a new device's performance through a clinical or non-clinical study directly comparing it to defined metrics. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices based on technological features, materials, and existing non-clinical test data.

Therefore, many of the requested elements about acceptance criteria and device performance based on a new study (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth establishment for a new training set) are not applicable or available in this kind of regulatory submission. The "acceptance criteria" here is primarily about meeting the requirements for substantial equivalence to a predicate device.

Let's break down what can be extracted and what cannot:

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

This document doesn't provide a table of acceptance criteria and reported device performance for the new device that would typically come from a specific study designed to show such performance. Instead, it leverages test results from predicate devices and applies them to the current device to demonstrate substantial equivalence.

The acceptance criteria here would implicitly be that the subject device's performance in mechanical properties, sterilization, biocompatibility, and shelf life is equivalent to or better than the predicate devices, as demonstrated by meeting established standards.

Acceptance Criteria (Implied)	Reported (Leveraged) Device Performance
For Sterilization:	Gamma Sterilization Validation Test (according to ISO11137-1,-2): Tests performed for predicate devices (K153639, K161244) were leveraged. The results "met the standards, and demonstrated the substantial equivalence with the predicate device."
For Shelf Life:	Shelf Life Validation Tests (referenced in K153639 and K161244):
- Tensile Strength (according to ASTM D882)	- Results "met the standards, and demonstrated the substantial equivalence."
- Seal Peeling (according to ASTM F88)	- Results "met the standards, and demonstrated the substantial equivalence."
- Burst Test (according to ASTM F1140)	- Results "met the standards, and demonstrated the substantial equivalence."
- Dye Penetration (according to ASTM F1929)	- Results "met the standards, and demonstrated the substantial equivalence."
- Bubble Test (according to ASTM F2096)	- Results "met the standards, and demonstrated the substantial equivalence."
For Mechanical Fatigue:	Fatigue Test (according to ISO 14801:2007): Tests performed for predicate devices (K150344, K153639) were leveraged. The results "met the standards, and demonstrated the substantial equivalence."
For Biocompatibility:	Biocompatibility Test (referenced in K161244):
- Cytotoxicity (according to ISO10993-5)	- Results "met the standards, and demonstrated the substantial equivalence."
- Sensitization (according to ISO10993-10)	- Results "met the standards, and demonstrated the substantial equivalence."
- Irritation (according to ISO10993-10)	- Results "met the standards, and demonstrated the substantial equivalence."
- Acute systemic toxicity (according to ISO 10993-11)	- Results "met the standards, and demonstrated the substantial equivalence."
- Implantation (according to ISO 10993-6)	- Results "met the standards, and demonstrated the substantial equivalence."
- Genotoxicity (according to ISO 10993-3)	- Results "met the standards, and demonstrated the substantial equivalence."
- Subchronic Toxicity (according to ISO 10993-11 and ISO 10993-6)	- Results "met the standards, and demonstrated the substantial equivalence."
For Endotoxin:	Endotoxin Test (according to USP <85>): Tests performed for predicate device (K161244) were leveraged. The results "met the standards, and demonstrated the substantial equivalence."
For Substantial Equivalence of Design/Dimensions/Materials:	The subject device adds new fixtures (diameters Ø3.7, Ø3.9) made of Ti-6Al-4V ELI (in addition to Pure Titanium Grade 4). This is supported by comparison to predicate K161244 (s-Clean OneQ-SL Narrow Implant System, made of Ti-6Al-4V-ELI) and K153639 which had similar diameters. The shelf life of 8 years is supported by predicate K161244 (8 years). The overall design, function, intended use, and material composition are stated to be similar to and substantially equivalent to the primary predicate K153639.

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

Sample Size: Not explicitly stated for each test (e.g., number of implants tested for fatigue). The document indicates that "Below tests were performed for predicate devices and leveraged for the subject device."
Data Provenance: The tests were performed for predicate devices (K153639, K161244, K150344). No information regarding the country of origin of the data is provided, nor whether it was retrospective or prospective. It is non-clinical lab testing data.

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

This is not applicable as the document relies on non-clinical testing against recognized standards (ISO, ASTM, USP) for demonstrating substantial equivalence, not expert ground truth for a clinical dataset.

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

This is not applicable as there is no clinical test set requiring adjudication in this submission.

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 is not applicable. This is a submission for an endosseous dental implant, which is a physical medical device, not an AI-assisted diagnostic tool.

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

This is not applicable. This refers to AI/algorithm performance, which is not relevant for this device.

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

For the non-clinical tests, the "ground truth" or reference for acceptance is the specified performance criteria within the referenced international standards (ISO, ASTM, USP) which determine if the device (or its predicate) performed adequately.

8. The sample size for the training set:

This is not applicable as this is not a submission for an AI/machine learning device that would require a training set.

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

This is not applicable as there is no training set for an AI/machine learning device.

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 text "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, stacked on top of each other.

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

April 27, 2017

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

Re: K170220

Trade/Device Name: OneQ-SL s-Clean Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: April 19, 2017 Received: April 19, 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.

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

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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 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 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.

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/1 description: The image shows the logo for DENTIS. The logo consists of an orange abstract shape on the left, resembling a flame or a stylized letter 'D'. To the right of the shape is the word "DENTIS" in a bold, sans-serif font. The overall design is clean and modern.

Dentis Co., Ltd.

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

Indication for Use

Device Name: OneO-SL s-Clean Implant System

Indication for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

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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

Device Information

Trade Name: OneQ-SL s-Clean Implant System Common Name: Endosseous Dental Implant Classification Name: Endosseous Dental Implant Product Code: DZE Regulation Number: 872.3640 Device Class: Class II Date Prepared: 04/13/2017

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

Description

The OneQ-SL s-Clean Implant system diameter and lengths are below:

. The OneO-SL s-Clean Fixtures
Internal Hex-connected, Bone level, submerged fixture, Tapered & Straight body Implant Fixture Dimension:

Division	Platform Diameters(Fixture Diameters)	Body Diameters	Lengths
Regular	Ø3.7	Ø3.5	7, 8, 10, 12, 14 mm
	Ø3.9	Ø3.6

The fixture is made of Ti-6A1-4V ELI and Pure Titanium Grade 4. The Cover screw was cleared in K073486. The surface is treated by Sand -blasting (Large grit) and acid etching method (SLA). This

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system only contains the implant bodies with cover screw and are provided as set-packing. The purpose of this submission is to add new fixtures.

Indication for Use

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, 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.

Predicate Devices & Comparison

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

K153639, OneQ-SL s-Clean Implant System by Dentis Co., Ltd. ●
. K161244, s-Clean OneQ-SL Narrow System by Dentis Co., Ltd.
. K150344, Dentis Dental Implant System by Dentis Co., Ltd.

Division	Subject Device	Primary Predicate	Reference Predicate
Device Name	OneQ-SL s-CleanImplant System	OneQ-SL s-CleanImplant System	s-Clean OneQ-SLNarrow ImplantSystem	Dentis Dental ImplantSystem
510(k) Number	N/A	K153639	K161244	K150344
Manufacturer	DENTIS CO., LTD.	DENTIS CO., LTD.	DENTIS CO., LTD.	DENTIS CO., LTD.
Material	Ti-6Al-4V-ELICP Titanium Gr.4	CP Titanium Gr.4	Ti-6Al-4V-ELI	CP Titanium Gr.4
Design(Fixture Type)	• Internal Hex-connected• Submerged Fixture• Bone level• Tapered & straightbody• 3 sided cutting edgewith self-tapping	• Internal Hex-connected• Submerged Fixture• Bone level• Tapered & straightbody• 3 sided cutting edgewith self-tapping	• Internal double hexconnection• Straight andtapered implantbody• 3 sided cutting edgeof bottom and bonelevel design	• Internal Hex-Connected• Submerged Fixture• Bone level, Taperedbody• 4 sided cutting edgewith self-tapping
FixtureDiameter	Ø3.7, Ø3.9	Ø3.7, Ø3.9, Ø4.2,Ø4.7, Ø5.2	Ø 3.0, Ø 3.3, Ø 3.7	Ø3.7, Ø4.1, Ø4.3,Ø4.8
Fixture Length	7, 8, 10, 12, 14 mm	7, 8, 10, 12, 14 mm	8, 10, 12, 14 mm	7, 8, 10, 12, 14 mm
SurfaceTreatment	SLA	SLA	SLA	RBM
GammaSterilized	Yes	Yes	Yes	Yes
Product Code	DZE	DZE, NHA	DZE, NHA	DZE, NHA
Shelf Life	8 years	1 year	8 years	5 years

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Indication foruse	The OneQ-SL s-CleanImplant System isindicated for use inpartially or fullyedentulous mandiblesand maxillae, insupport of single ormultiple unitrestorations including;cemented retained,screw retained, oroverdenturerestorations, andterminal orintermediate abutmentsupport for fixed	The OneQ-SL s-CleanImplant System isindicated for use inpartially or fullyedentulous mandiblesand maxillae, insupport of single ormultiple unitrestorations including;cemented retained,screw retained, oroverdenturerestorations, andterminal orintermediate abutmentsupport for fixed	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 berestored immediately1) with a temporaryprosthesis that is notin functionalocclusion,2) when splintedtogether as anartificial rootstructure for multipletooth replacement ofmandibular incisors,or3) for denturestabilization usingmultiple implants inthe anterior mandibleand maxilla.The implants may beplaced in immediatefunction when goodprimary stability hasbeen achieved andwith appropriateocclusal loading.	The Dentis DentalImplant System isindicated for use inpartially or fullyedentulous mandiblesand maxillae, insupport of single ormultiple-unitrestorationsincluding; cementedretained, screwretained, oroverdenturerestorations, andterminal orintermediateabutment support forfixed bridgework.This system isdedicated for one andtwo stage surgicalprocedures and notdedicated forimmediate loading.This system isintended for delayedloading.
	bridgework. Thissystem is dedicated forone and two stagesurgical procedures.This system isintended for delayedloading.	bridgework. Thissystem is dedicated forone and two stagesurgical procedures.This system isintended for delayedloading.

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K170220

Substantial Equivalence Discussion

The subject device shares identical Indications for Use statement as the primary predicate device (K153639). The technological features of the subject device differ from the primary predicate in the following ways:

Addition of 3.7mm and 3.9mm diameter of Implants made of Ti-6A1-4V (ELI)
. 8 years of Shelf Life

The reference predicates, s-Clean OneQ-SL Narrow Implant System (K161244) and dentis dental implant system (K153639), support substantial equivalence of the addition of 3.7mm and 3.9mm diameter of Implants with different material and shelf life.

Non-Clinical Test Data

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

Gamma Sterilization Validation Test according to ISO11137-1,- 2 referenced in K153639 and . K161244
. Shelf life Validation Tests referenced in K153639 and K161244
- Tensile Test according to ASTM D882 -
- । Seal Peeling Test according to ASTM F88
- Burst Test according to ASTM F1140 -
- Dye penetration Test according to ASTM F1929 -
- -Bubble Test according to ASTM F2096
Fatigue Test according to ISO 14801:2007 referenced in K150344 and K153639 .
- Biocompatibility Test referenced in K161244
  - Cytotoxicity according to ISO10993-5 -
  - Sensitization according to ISO10993-10 -
  - Irritation according to ISO10993-10 -
  - Acute systemic toxicity according to ISO 10993-11 -
  - -Implantation according to ISO 10993-6
  - Genotoxicity according to ISO 10993-3 -
  - Subchronic Toxicity according to ISO 10993-11 and ISO 10993-6 -
. Endotoxin Test according to USP <85> referenced in K161244

Those tests have been performed to evaluate the substantial equivalence in the surface characteristics compared to the predicate device. The results of the above tests have met the standards, and demonstrated the substantial equivalence with the predicate device.

Summary of clinical testing

No clinical testing was performed for this submission.

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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 OneQ-SL s-Clean 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.