The OneQ-SL 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 intended for delayed loading.

Device Description

The OneQ-SL 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. The OneQ-SL Implant system includes the i-Clean OneQ Fixtures which are Internal Octa-connected, non-submerged fixtures. The fixture is made of CP Titanium Grade 4. The surface is treated by Sand -blasting (Large grit) and acid etching method (SLA). The Fixtures are supplied sterile.

AI/ML Overview

This document describes a 510(k) premarket notification for the OneQ-SL Implant System, a dental implant device. Therefore, the information typically requested in your prompt regarding acceptance criteria and study details for an AI/CADe device will not be present. This document does not describe a study that uses AI for diagnostic or screening purposes. Instead, it describes non-clinical testing performed to establish substantial equivalence to a predicate device.

Here's the breakdown of why I cannot answer your prompt with the given document:

No AI/CADe device: The OneQ-SL Implant System is a physical dental implant, not an AI or CADe (Computer-Aided Detection) device. The document details its material, design, and intended use as a surgically placed implant.
Substantial Equivalence Study: The document is a 510(k) summary, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This is a common regulatory pathway for medical devices that are not high-risk and do not introduce novel technology.
Non-Clinical Testing: The "study" mentioned here refers to non-clinical tests (packaging, sterilization, fatigue, cytotoxicity) to confirm the device meets certain standards and safety requirements, not to evaluate diagnostic accuracy or human reader performance.

Therefore, the following points from your request cannot be addressed by this document:

A table of acceptance criteria and the reported device performance.
Sample sized used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
Adjudication method.
If a multi reader multi case (MRMC) comparative effectiveness study was done.
If a standalone performance was done.
The type of ground truth used.
The sample size for the training set.
How the ground truth for the training set was established.

Summary of available information (related to non-clinical testing for substantial equivalence):

The document states that the OneQ-SL Implant System underwent the following non-clinical tests to evaluate its performance and demonstrate substantial equivalence to the predicate device (K120847, ET/SS Implant System manufactured by Osstem Implant Co., Ltd.):

Packaging Test: Performed in accordance with ISO11607-1:2006 and ISO11607-2:2006.
Sterilization Validation Test: Performed in accordance with ISO11137-1:2006 and ISO11137-2:2013.
Fatigue Test: Performed in accordance with ISO14801:2007.
Cytotoxicity Test: Performed according to ISO 10993-5:2009.

Acceptance Criteria and Reported Device Performance (Non-Clinical):

Acceptance Criteria / Standard	Reported Device Performance
Packaging: ISO11607-1:2006 and ISO11607-2:2006	"The result of the above tests have met the standard, and proved the substantial equivalence with the predicate device." (Specific numerical results are not provided in this summary document)
Sterilization Validation: ISO11137-1:2006 and ISO11137-2:2013	"The result of the above tests have met the standard, and proved the substantial equivalence with the predicate device." (Specific numerical results are not provided in this summary document)
Fatigue: ISO14801:2007	"The result of the above tests have met the standard, and proved the substantial equivalence with the predicate device." (Specific numerical results are not provided in this summary document)
Cytotoxicity: ISO 10993-5:2009	"The result of the above tests have met the standard, and proved the substantial equivalence with the predicate device." (Specific numerical results are not provided in this summary document)

Ground Truth for Non-Clinical Tests: For these non-clinical tests, "ground truth" is established by the methods and requirements specified in the respective ISO standards. For example, for the fatigue test, the ground truth would be resistance to a certain number of cycles at a defined load without failure. For cytotoxicity, it would be the absence of toxic effects as per the ISO standard for biological evaluation of medical devices.

Clinical Testing: The document explicitly states: "No additional clinical testing was performed for this submission." This further confirms that this is not an AI/CADe study involving human readers or diagnostic accuracy.

Summary

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

December 10, 2015

Dentis Co. Ltd. c/o Ms. April Lee Consultant Withus Group Inc. 2531 Pepperdale Drive Rowland Heights, CA 91748

Re: K142313

Trade/Device Name: OneQ-SL Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: November 3, 2015 Received: November 10, 2015

Dear Ms. 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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Page 2 - Ms. April Lee

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 yours,

Tina Kiang
-S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142313

Device Name OneO-SL 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)

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510(K) Summary

Submitter

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

Device Information

Trade Name: OneQ-SL Implant System Common Name: Endosseous Dental Implant Classification Name: Implant, Endosseous, Root-Form Product Code: DZE Regulation Number: 872.3640 Device Class: Class II Date Prepared: 12/09/2015

Description

The OneQ-SL 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.

The OneQ-SL Implant system includes;

. The i-Clean OneQ Fixtures Internal Octa-connected, non-submerged fixture

Platform Diameter	Implant Nominal (Coronal)Diameter (mm)	Implant ApicalDiameter (mm)	Lengths Available(mm)
Regular: Ø 4.8 mm	3.7	3.55	7, 8, 10, 12, 14
	4.2	3.7	7, 8, 10, 12, 14
	4.7	4.2	7, 8, 10, 12, 14
	5.2	4.7	7, 8, 10, 12, 14
Wide: Ø 6.5 mm	4.2	3.7	7, 8, 10, 12, 14
	4.7	4.2	7, 8, 10, 12, 14
	5.2	4.7	7, 8, 10, 12, 14
	6.0	4.8	7, 8, 10, 12
	7.0	5.75	7, 8, 10, 12

The fixture is made of CP Titanium Grade 4. The surface is treated by Sand -blasting (Large grit) and acid etching method (SLA). The Fixtures are supplied sterile.

Indication for Use

The OneQ-SL 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

Official Correspondent

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

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retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is intended for delayed loading.

Predicate Devices & Comparison

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

K120847, ET/SS Implant System manufactured by Osstem Implant Co., Ltd. ●

	Subject Device	Predicate Device
Device Name	OneQ-SL Regular / Wide TypeFixture	ET/SS Implant System(SSII/III SA Fixture)
510(k) Number	K142313	K120847
Manufacturer	DENTIS CO., LTD.	OSSTEM Implant Co., Ltd.
Intended Use	Mandible and Maxilla EndosseousDental Implant & Accessories.	Mandible and Maxilla EndosseousDental Implant & Accessories.
Material	CP Titanium Gr.4	CP Titanium Gr.4
Design(Fixture Type)	- Internal Octa-connected- Non-Submerged Fixture- Tapered & straight body	- Internal Octa-connected- Non-Submerged Fixture- Straight & Tapered Body
Platform Diameter(Coronal)	4.8~6.5	4.8~6.0
Fixture Diameter	Regular: Ø 3.7, Ø 4.2, Ø 4.7, Ø 5.2Wide: Ø 4.2, Ø 4.7, Ø 5.2, Ø 6.0,Ø 7.0	SSII SA Fixture: Ø 4.1-4.9SSIII SA Fixture: Ø 3.75-5.0
Fixture Length	Regular: 7, 8, 10 ,12, 14 mmWide: 7, 8, 10 ,12, 14mm14mm not for all diameters	6~15 mm
Indication for use	The OneQ-SL Implant System isindicated for use in partially or fullyedentulous mandibles and maxillae,in support of single or multiple-unitrestorations including; cementedretained, screw retained, oroverdenture restorations, and terminalor intermediate abutment support forfixed bridgework. This system isintended for delayed loading.	ET/SS Implant System is indicatedfor use in partially or fully edentulousmandibles and maxillae, in support ofsingle or multiple-unit restorationsincluding; cemented retained, screwretained, or overdenturerestorations, and final or temporaryabutment support for fixedbridgework. It is intended for delayedloading.
Surface Treatment	SLA	SLA
Gamma Sterilized	Yes	Yes
Product Code	DZE	DZE

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Substantial Equivalence Discussion

The OneQ-SL Implant System has a substantially equivalent intended use as the identified predicates. The subject device is similar 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 similar in indications, design, technology, functions, dimensions and materials.

The differences between the subject device and predicate devices are slight differences in fixture's diameters and lengths.

Differences in technological characteristics do not raise different questions of safety and effectiveness compared to the predicate device.

Non-Clinical Test Data

The subject device was tested to evaluate its performance according to the following standards:

Packaging Test performed in accordance with ISO11607-1:2006 and ISO11607-2:2006 ●
. Sterilization Validation Test performed in accordance with ISO11137-1:2006 and ISO11137-2:2013
Fatigue Test performed in accordance with ISO14801:2007
Cytotoxicity Test performed according to ISO 10993-5:2009 .

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

Non-clinical testing consisted of performance of testing in accordance with the FDA guidance "Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." The results of the non-clinical testing demonstrate that the subject device is substantially equivalent to the predicate device.

Summary of clinical testing

No additional 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 Implant Co., Ltd. Concludes that the OneQ-SL 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.