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

with a temporary prosthesis that is not in functional occlusion,
when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
for denture stabilization using multiple implants in the anterior mandible and maxilla.

The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

Device Description

The s-Clean OneQ-SL Narrow Implant System is used to replace missing teeth in various situations ranging from a single tooth loss to the complete loss of incisors teeth. This system is restricted to substitute the maxillary lateral incisors and mandibular incisors. It is one and two stage endosseous screw type implant with internal double hexagonal connection, intended for single use. The s-Clean OneQ-SL Narrow Implant System is a suitable treatment option when the possibility of placing a standard implants is limited due to physical conditions, where the horizontal space is limited by adjacent teeth and roots, or in situations with a narrow alveola ridge.

This system consists of the fixture, cover screw, various abutments and prostheses. Only the subject abutments can be used with the subject fixtures.

AI/ML Overview

This document describes the regulatory submission for the s-Clean OneQ-SL Narrow Implant System by Dentis Co., Ltd. The document is primarily a 510(k) summary demonstrating substantial equivalence to predicate devices, rather than a standalone study documenting acceptance criteria and performance. Therefore, detailed information on acceptance criteria and specific study results proving the device meets those criteria, particularly for clinical outcomes, is limited.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with quantified performance targets and corresponding device performance for direct comparison in the way a clinical study report would. Instead, it relies on non-clinical testing against recognized standards to demonstrate equivalence.

The "acceptance criteria" are implied by adherence to these standards and the demonstration of "substantial equivalence" to predicate devices. The "reported device performance" is essentially that the device met the criteria of these standards and demonstrated substantial equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Absence of adverse biological reactions per ISO 10993 standards.	Met criteria of ISO 10993-1, ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-11.
Fatigue strength: Mechanical durability under cyclic loading per ISO 14801.	Met criteria of ISO 14801:2007.
Endotoxin levels: Within acceptable limits per USP <85>.	Met criteria of USP <85>.
Sterilization validation: Effective terminal sterilization (gamma) per ISO 11137.	Met criteria of ISO 11137-1, ISO 11137-2 (leveraged from predicate).
End-user steam sterilization: Effective sterilization for non-sterile components per ISO 17665-1,-2 and ANSI/AAMI ST79.	Met criteria of ISO 17665-1,-2 and ANSI/AAMI ST79 (leveraged from predicate).
Shelf life: Packaging integrity and product sterility maintained per ISO 11607 and ASTM F1980.	Met criteria of ISO 11607-1, ISO 11607-2, and ASTM F1980-07 (leveraged from predicate).
Surface characteristics: Equivalence to predicate devices.	Evaluated by Scanning Electron Microscopy and Energy Dispersive Spectroscopy, results demonstrated substantial equivalence.
Structural Integrity: Per applicable sections of "Guidance for Industry and Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".	Met guidance document requirements.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of human clinical data. All reported tests are non-clinical (biocompatibility, fatigue, endotoxin, sterilization, shelf life, surface characterization).

For non-clinical tests, sample sizes would typically be determined by the specific standards (e.g., ISO 14801 for fatigue testing might specify a minimum number of samples). The document states the tests were performed "for predicate devices and leveraged for the subject device" or "for the subject device." No specific sample numbers for these non-clinical tests are provided.

The "data provenance" for non-clinical tests is from the manufacturer's own testing (Dentis Co., Ltd.) or testing supporting their predicate devices. There is no mention of country of origin for non-clinical test data, but the manufacturer is based in South Korea.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is a non-clinical submission demonstrating substantial equivalence through engineering and material testing, not human clinical trials requiring expert ground truth establishment for a test set.

4. Adjudication Method for the Test Set

Not applicable for a non-clinical 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

Not applicable. This device is a dental implant system, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was performed or is relevant.

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

Not applicable. This is a physical medical device (dental implant system), not an algorithm or software. Its performance is evaluated through material and mechanical testing, not algorithm performance.

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

For the non-clinical tests, the "ground truth" is established by the specifications and pass/fail criteria defined in the referenced international standards (e.g., ISO 10993, ISO 14801, USP <85>), and by demonstrating material/design equivalence to legally marketed predicate devices. There is no biological "ground truth" from pathology or outcomes data generated by this submission directly for the subject device.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

Not applicable. There is no "training set" for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, forming a single, abstract figure.

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

December 7, 2016

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

Re: K161244

Trade/Device Name: s-Clean OneO-SL Narrow Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 1, 2016 Received: November 7, 2016

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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related 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 yours,

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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Indications for Use

510(k) Number (if known) K161244

Device Name

s-Clean OneQ-SL Narrow Implant System

Indications for Use (Describe)

The implants may be restored immediately

with a temporary prosthesis that is not in functional occlusion.
when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
for denture stabilization using multiple implants in the anterior mandible and maxilla.

The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

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. 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: s-Clean OneQ-SL Narrow Implant System Common Name: Endosseous Dental Implant Classification Name: Implant, Endosseous, Root-Form Product Code: DZE, NHA Regulation Number: 872.3640 Device Class: Class II Date Prepared: 11/29/2016

Indication for Use

The s-Clean OneO-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,
1. when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
1. for denture stabilization using multiple implants in the anterior mandible and maxilla.

The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

Device Description

This system consists of the fixture, cover screw, various abutments and prostheses. Only the subject abutments can be used with the subject fixtures.

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Fixture

This fixture design has straight and tapered implant body, 3 sided cutting edge of bottom, internal double hex connection and bone level implant. The Fixture diameters are 3.0 and 3.3 mm and the lengths are 10, 12 and 14mm.

This product is a dental implant which is placed in the maxillary and mandibular bone to support and maintain upper prostheses or denture. Fixture, the lower part of the main body, is made of Ti-6AI-4V ELI for Narrow type, and SLA (Sand-blasted, Large grit, Acid-etched surface) surface treated. Fixture and cover screw are provided sterile.

Abutment

The various abutments in this system include s-clean sole narrow abutment, healing cap, s-clean narrow temporary abutment, s-clean narrow O-ring abutment, s-clean narrow healing abutment, s-clean narrow gold UCLA abutment, and s-clean narrow CCM Abutment.

Item	Description	Dimension	Materials
s-Clean Sole Abutment(Narrow)	upper structure used to produce a dentalprosthesis bridge for 2~3 or more teeth..	Ø 4.0 mm (D) x 9.4,10.4, 10.9, 11.9, 12.4,12.9, 13.4, 14.4, 14.9and 15.9 mm (L)	Ti-6Al-4V ELI
Healing Cap	connected sole abutment after connectionto sole abutment and contact to gingivaduration 15 days less to protect to tongue	Ø 4.6 mm (D) x 6, 7.5and 9 mm (L)	Acetal
s-Clean TemporaryAbutment (Narrow)	Arbitrarily shaped upper structure used torestore masticatory movementtemporarily by using prosthesis madeaccording to patient's condition	Ø 4.0 mm (D) x 12.5and 13 mm (L)	Titanium Grade 4
s-Clean O-RingAbutment (Narrow)	Ball type upper structure connects withthe top of implant fixture to connect withover denture	Ø 3.5 mm (D) x 10 and12 mm (L)	Ti-6Al-4V ELI
s-Clean HealingAbutment (Narrow)	Can be made emergence profile ongingiva for next connecting abutment andbe used period 15 days fromsecondsurgery normally	Ø 4.0 mm (D) x 7.9,8.4, 8.9, 9.4, 9.9, 10.4,10.9 and 11.4 mm (L)	Titanium Grade 4
s-Clean Gold UCLAAbutment (Narrow)	Make castable abutment and is screwretained type	Ø 4.0 mm (D) x 14.5and 15 mm (L)	Gold
s-Clean CCM Abutment(Narrow)	Make castable abutment and is screwretained type	Ø 4.0 mm (D) x 14.5and 15 mm (L)	Co-Cr-Mo Alloy
s-Clean AbutmentScrew	Connection body to connect abutment tofixture	Ø 2.03 mm (D) x 9 mm(L)	Ti-6Al-4V ELI

The Healing Abutments are provided sterile and other abutments are provided non-sterile. The abutments should be sterilized before use (End user sterilization).

The temporary abutments, CCM abutments and UCLA abutments are not intended to be cast at angulation or placed to provide angular correction.

Principle of Operation

This product is a dental implant to implant in the jaw to maintain support for partial or full prosthetic restorations teeth or dentures when the loss of teeth as the fixture dental implant, the body (substructure) made titanium and was treated SLA surface.

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K161244

Predicate Devices & Comparison

1) Fixtures

K093321, BioHorizons Laser-Lok 3.0 Implant System
K130462, Paltop Narrow Implant ●
K150344, Dentis Dental Implant System .
K111364, Dentis HAPTITE Implant system

	Subject device	Primary Predicate	Reference Predicates
Device name	s-Clean OneQ-SL NarrowImplant System	BioHorizons Laser-Lok3.0 Implant System	Paltop Narrow Implant	Dentis Dental ImplantSystem	Dentis HAPTITEImplant system
510(k) number	K161244	K093321	K130462	K150344	K111364
Manufacturer	Dentis Co., Ltd.	BioHorizons ImplantSystems, Inc	Paltop AdvancedDental Solutions, Ltd.	Dentis Co., Ltd.	Dentis Co., Ltd.
Material	Ti-6Al-4V ELI	Ti-6Al-4V ELI	Ti-6Al-4V ELI	CP Titanium Grade 4	CP Titanium Grade 4
Design	Image: s-Clean OneQ-SL Narrow Implant System	Image: BioHorizons Laser-Lok 3.0 Implant System	Image: Paltop Narrow Implant	Image: Dentis Dental Implant System	Image: Dentis HAPTITE Implant system
Design andtechnologicalfeatures	Straight and tapered implantbody, 3 sided cutting edge ofbottom, internal double hexconnection and bone leveldesign.	Straight and taperedimplant body, Laser-Lokcollar, Parallel wall,Internal hex connectionand bone level design.	Straight and taperedimplant body, 3 sidedcutting edge of bottom,internal hex connectionand bone level design.	Tapered implant body, 4sided cutting edge ofbottom, internal hexconnection and bonelevel design.	Tapered implant body,4 sided cutting edge ofbottom, internal hexconnection and bonelevel design.
Fixturediameter(Ø)	3.0, 3.3 mm	3.0mm	3.25 mm	3.7, 4.1, 4.3, 4.8mm	3.7, 4.1, 4.3, 4.8, 5.5,6.0, 6.5, and 7.0mm
Fixture length	10 ,12, 14 mm	10.5, 12, 15mm	10,11.5,13,16 mm	7, 8, 10 ,12, 14 mm	7, 8, 9, 10 ,12, 14 and16mm
Indication for use	The s-Clean OneQ-SL NarrowImplant System (3.0, 3.3mm)may be used as an artificialroot structure for single toothreplacement of mandibularcentral and lateral incisors andmaxillary lateral incisors.The implants may be restoredimmediately1) with a temporary prosthesisthat is not in functionalocclusion,2) when splinted together asan artificial root structure formultiple tooth replacement ofmandibular incisors, or3) for denture stabilizationusing multiple implants in theanterior mandible and maxilla.The implants may be placed inimmediate function whengood primary stability hasbeen achieved and withappropriate occlusal loading.	BioHorizons Laser-Lok3.0 Implants may be usedas an artificial rootstructure for single toothreplacement ofmandibular central andlateral incisors andmaxillary lateral incisors.The implants may berestored immediately1) with a temporaryprosthesis that is not infunctional occlusion,2) when splinted togetheras an artificial rootstructure for multipletooth replacement ofmandibular incisors, or3) for denturestabilization usingmultiple implants in theanterior mandible andmaxilla.The implants may beplaced in immediatefunction when goodprimary stability has beenachieved and withappropriate occlusalloading.	The Peltop NarrowImplant is indicated foruse in surgical andrestorative applicationsfor placement in themandibular central,lateral incisor andmaxillary lateralincisor regions ofpartially edentulousjaws where thehorizontal space islimited by the adjacentteeth and roots, toprovide support forprosthetic devices,such as artificial teeth,in order to restore thepatient's chewingfunction. The PaltopNarrow Implant isindicated also forimmediate loadingwhen good primarystability is achievedand with appropriateocclusal loading.	The Dentis DentalImplant System is anendosseous dentalimplant is indicated forsurgical placement inthe upper and lower jawarches, to provide a rootform means for single ormultiple-units prostheticappliance attachment torestore a patient'schewing function.Implants can be placedwith a conventional twostage surgical processwith an option fortransmucosal healing orthey can be placed in asingle stage surgicalprocess for immediateloading. Immediateloading is restricted tothe anterior mandiblebased on four splintedinterforminal placedimplants.	The Dentis ImplantSystem is indicated foruse in partially or fullyedentulous mandiblesand maxillae, insupport of single ormultiple-unitrestorations including;cemented retained,screw retained, oroverdenturerestorations, andterminal orintermediate abutmentsupport for fixedbridgework. Thissystem is dedicated forone and two stagesurgical proceduresand not dedicated forimmediate loading.This system is intendedfor delayed loading.
Surface treatment	SLA	RBM	SLA	RBM	HA Coating
Principle of	Conventional procedure	Conventional procedure	Conventional	Conventional procedure	Conventional

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Operation	procedure	procedure
Anatomical Site	Oral cavitymandibles and maxillae	Oral cavitymandibles and maxillae	Oral cavitymandibles and maxillae	Oral cavitymandibles and maxillae	Oral cavitymandibles and maxillae
Gamma sterilized	Yes	Yes	Yes	Yes	Yes
Abutment	Straight only	Straight and angled	Straight and angled(20°)	Straight and angled(30°)	Straight andangled(25°)
MaterialComposition ofAbutments	CP Titanium Grade 4,Ti-6Al-4V ELI,CCM Alloy,Acetal, Gold	Titanium Alloy	Titanium Alloy	CP Titanium Grade 4Ti-6Al-4V ELI,CCM Alloy, Acetal	CP Titanium Grade 3and 4Ti-6Al-4V ELI,PEEK, Gold, Acetal
Surface Treatmentof Abutments	None	None	None	None	None
Product Code	DZE, NHA	DZE	DZE, NHA	DZE, NHA	DZE, NHA

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2) Abutments

K150344, Dentis Dental Implant System
K111364, Dentis HAPTITE Implant system
K073486, Dentis Dental Implant System

Sole Abutment

K number	K161244 (Subject)	K150344	K111364
Product Name	s-Clean Sole Abutment (Narrow)	-	s-Clean Sole Abutment
Intended Use	The s-Clean OneQ-SL Narrow Implant System (3.0,3.3mm) may be used as an artificial root structure forsingle tooth replacement of mandibular central andlateral incisors and maxillary lateral incisors.The implants may be restored immediately1) with a temporary prosthesis that is not in functionalocclusion,2) when splinted together as an artificial root structurefor multiple tooth replacement of mandibular incisors, or3) for denture stabilization using multiple implants inthe anterior mandible and maxilla.The implants may be placed in immediate function whengood primary stability has been achieved and withappropriate occlusal loading.	The Dentis Dental Implant System is anendosseous dental implant is indicated forsurgical placement in the upper and lowerjaw arches, to provide a root form meansfor single or multiple-units prostheticappliance attachment to restore a patient'schewing function. Implants can be placedwith a conventional two stage surgicalprocess with an option for transmucosalhealing or they can be placed in a singlestage surgical process for immediateloading. Immediateloading is restricted to the anteriormandible based on four splintedinterforminal placed implants.	The HAPTITE coating ImplantSystem is indicated for use in partiallyor fully edentulous mandibles andmaxillae, in support of single ormultiple-unit restorations including;cemented retained, screw retained, oroverdenture restorations, and terminalor intermediate abutment support forfixed bridgework. This system isdedicated for one and two stagesurgical procedures and not dedicatedfor immediate loading. This system isintended for delayed loading.
Materials	Ti-6Al-4V ELI / Non coating	-	Ti-6Al-4V ELI / Non coating
Dimension	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)	-	Ø 4.5, 5.5, 6.5 mm (D) x 12.5, 13,13.5, 14, 15, 16, 17mm (L)Ø 4.8, 6.0 mm(D) x 13.3, 14.3, 15.3,16.3, 17.3 mm(L)
Healing Cap
Product Name	Healing Cap	MU Healing Cap	Healing Cap
Materials	Acetal / Non coating	Ti-6Al-4V ELI / Non coating	Acetal / Non coating
Dimension	Ø 4.6 mm (D) x 6, 7.5, 9 mm (L)	Ø 5.4 mm (D) x 5 mm (L)	Ø 5.1, 5.8, 6.3, 6.8 mm (D) x 6.5 mm(L)

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Temporary Abutment
Product Name	s-Clean Temporary Abutment (Narrow)	MU Temporary Cylinder	s-Clean Temporary Abutment
Materials	Titanium Grade 4 / Non coating	Titanium Grade 4 / Non coating	Titanium Grade 4 / Non coating
Dimension	Ø 4.0 mm (D) x 12.5, 13 mm (L)	Ø 4.8 mm (D) x 10 mm (L)	Ø 4.8, 6.0 mm (D) x 13.8 mm (L)
O-ring Abutment
Product Name	s-Clean O-Ring Abutment (Narrow)	-	s-Clean O-Ring Abutment
Materials	Ti-6Al-4V ELI / Non coating	-	Ti-6Al-4V ELI / Non coating
Dimension	Ø 3.5 mm (D) x 10, 12 mm (L)	-	Ø 3.4, 4.5 mm (D) x 10.1, 11.6, 13.6mm (L)
Gold UCLA Abutment
Product Name	s-Clean Gold UCLA Abutment (Narrow)	MU Gold Cylinder	s-Clean GOLD UCLA Abutment
Materials	Gold/AcetalNon coating	Gold/AcetalNon coating	Gold/AcetalNon coating
Dimension	Ø 4.0 mm (D) x 14.5, 15 mm (L)	Ø 4.8 mm (D) x 14.25 mm (L)	Ø 4.5 mm (D) x 14.4, 15.3 mm (L)
CCM Abutment
Product Name	s-Clean CCM Abutment (Narrow)	MU CCM Cylinder	-
Materials	Co-Cr-Mo Alloy / Non coating	Co-Cr-Mo Alloy /Non coating	-
Dimension	Ø 4.0 mm (D) x 14.5, 15 mm (L)	Ø 4.8 mm (D) x 14.25 mm (L)	-
Abutment Screw
Product Name	s-Clean Abutment Screw	MU Abutment Screw(2)	s-Clean Abutment Screw
Materials	Ti-6Al-4V ELI / Non coating	Ti-6Al-4V ELI / Non coating	Ti-6Al-4V ELI / Non coating
Dimension	Ø 2.03 mm (D) x 9 mm (L)	Ø 2.32 mm (D) x 7.8 mm (L)	Ø 2.3 mm (D) x 9.75, 9.95,10.5mm (L)
Healing Abutment
K number	K161244 (Subject)	K073486
Product Name	s-Clean Healing Abutment (Narrow)	Healing Abutment
Intended Use	The s-Clean OneQ-SL Narrow Implant System (3.0, 3.3mm) maybe used as an artificial root structure for single tooth replacementof mandibular central and lateral incisors and maxillary lateralincisors.The implants may be restored immediately1) with a temporary prosthesis that is not in functional occlusion,2) when splinted together as an artificial root structure for multipletooth replacement of mandibular incisors, or3) for denture stabilization using multiple implants in the anteriormandible and maxilla.The implants may be placed in immediate function when goodprimary stability has been achieved and with appropriate occlusalloading.	The Dentis Dental Implant system is an endosseous dental implantthat is indicated to use for surgical placement in the upper andlower jaw arches, to provide a root form means for single ormultiple units' prosthetic appliance attachment to restore a patient'schewing function. Implants can be placed with a conventional twostage surgical process with an option for transmucosal healing orthey can be placed in a single stage surgical process for immediateloading. Immediate loading is restricted to the anterior mandible,based on four splinted interforminal placed implants, and notindicated for single, unsplinted implants.
Materials	Titanium Grade 4Non coating	Titanium Grade 4Non coating
Dimension	Ø 4.0 mm (D) x 7.9, 8.4, 8.9, 9.4, 9.9, 10.4, 10.9, 11.4 mm (L)	Ø 4.5, 5.0, 5.5, 6.0 mm (D) x 1.0, 1.5, 2.0, 2.5, 3.5, 4.5, 5.5 mm (Cuff L)Ø 6.5, 7.0 mm (D) x 1.5, 2.0, 2.5, 3.5, 4.5, 5.5 mm (Cuff L)

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Substantial Equivalence Discussion

The subject device shares identical Indications for Use statement as the primary predicate device (K093321). The technological features of the subject device differ from the primary predicate in the following ways:

Addition of 3.3 mm diameter implants
Different abutment designs ●
. Different modified surfaces

The reference predicate, Paltop Narrow Implant (K130462), supports substantial equivalence of the subject device's 3.3 mm diameter implants. The reference predicates, Dental Implant System (K150344) and Dentis HAPTITE Implant System (K111364), contain identical types of abutment designs as the subject device, thus supporting the substantial equivalence of the subject device's abutments.

Non-Clinical Test Data

The subject device was tested to evaluate its substantial equivalence according to the following standards.

Biocompatibility tests according to ISO 10993-1, ISO 10993-5, ISO 10993-6, ISO 10993-10 . and ISO 10993-11.
. Fatigue Test according to ISO 14801:2007
. Endotoxin Test according to USP <85>

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 ●
. End User Steam Sterilization Test according to ISO 17665-1.-2 and ANSI/AAMI ST79 referenced in K11364
Shelf life Validation Test according to ISO 11607-1, -2, and ASTM F1980-07 referenced in K153639 and ● K073486

Modified surfaces characterization by Scanning Electron Microscopy and Energy Dispersive Spectroscopy have been performed to evaluate the substantial equivalence in the surface characteristics compared to the predicate devices according to "Guidance for Industry and Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments". The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device.

Fatigue evaluation was performed for demonstrating substantial equivalence under worst case scenario in accordance with ISO 14801 and "Guidance for Industry and Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".

The gamma sterilization validation, end user steam sterilization testing were reference in the predicate devices.

Sterilization validation tests were performed for predicate device and leveraged for the subject device because the predicate device has bigger surface area and mass than the subject device, which is the worst case. The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.

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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 Co., Ltd. concludes that the s-Clean OneQ-SL Narrow 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.