Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a dental implant system and its components, focusing on materials, mechanical properties, and intended use for tooth replacement. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies are standard non-clinical tests for medical devices, not related to AI/ML model performance.

Therapeutic

Yes
The device is described as an "artificial root structure" and replaces "missing teeth," directly addressing a physical condition to restore function, which aligns with the definition of a therapeutic device.

Diagnostic

No

The device is an implant system used to replace missing teeth, acting as an artificial root structure, rather than detecting or diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is an "endosseous screw type implant" and consists of "the fixture, cover screw, various abutments and prostheses," which are all physical hardware components.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use describes the device as an "artificial root structure" for replacing missing teeth. This is a surgical implant, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
Device Description: The description details a physical implant system consisting of fixtures, cover screws, abutments, and prostheses. This aligns with a medical device used for surgical implantation, not an IVD.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, calibrators, controls, or any other components typically associated with in vitro diagnostics.
Performance Studies: The performance studies focus on biocompatibility, fatigue, sterilization, and shelf life, which are relevant to implantable medical devices, not IVDs.

Therefore, the s-Clean OneQ-SL Narrow Implant System is a medical device, specifically a dental implant, and not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

DZE, NHA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Oral cavity mandibles and maxillae

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Test Data:

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

Tests 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".
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.

Summary of clinical testing:
No additional clinical testing was performed for this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K093321, K150344, K111364

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K130462, K073486

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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

1

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

2

Indications for Use

510(k) Number (if known) K161244

Device Name

s-Clean OneQ-SL Narrow Implant System

Indications for Use (Describe)

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.

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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3

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

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.

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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 dental
prosthesis 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, 14.9
and 15.9 mm (L)	Ti-6Al-4V ELI
Healing Cap	connected sole abutment after connection
to sole abutment and contact to gingiva
duration 15 days less to protect to tongue	Ø 4.6 mm (D) x 6, 7.5
and 9 mm (L)	Acetal
s-Clean Temporary
Abutment (Narrow)	Arbitrarily shaped upper structure used to
restore masticatory movement
temporarily by using prosthesis made
according to patient's condition	Ø 4.0 mm (D) x 12.5
and 13 mm (L)	Titanium Grade 4
s-Clean O-Ring
Abutment (Narrow)	Ball type upper structure connects with
the top of implant fixture to connect with
over denture	Ø 3.5 mm (D) x 10 and
12 mm (L)	Ti-6Al-4V ELI
s-Clean Healing
Abutment (Narrow)	Can be made emergence profile on
gingiva for next connecting abutment and
be used period 15 days from
secondsurgery 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 UCLA
Abutment (Narrow)	Make castable abutment and is screw
retained type	Ø 4.0 mm (D) x 14.5
and 15 mm (L)	Gold
s-Clean CCM Abutment
(Narrow)	Make castable abutment and is screw
retained type	Ø 4.0 mm (D) x 14.5
and 15 mm (L)	Co-Cr-Mo Alloy
s-Clean Abutment
Screw	Connection body to connect abutment to
fixture	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 Narrow
Implant System	BioHorizons Laser-Lok
3.0 Implant System	Paltop Narrow Implant	Dentis Dental Implant
System	Dentis HAPTITE
Implant system
510(k) number	K161244	K093321	K130462	K150344	K111364
Manufacturer	Dentis Co., Ltd.	BioHorizons Implant
Systems, Inc	Paltop Advanced
Dental 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 and
technological
features	Straight and tapered implant
body, 3 sided cutting edge of
bottom, internal double hex
connection and bone level
design.	Straight and tapered
implant body, Laser-Lok
collar, Parallel wall,
Internal hex connection
and bone level design.	Straight and tapered
implant body, 3 sided
cutting edge of bottom,
internal hex connection
and bone level design.	Tapered implant body, 4
sided cutting edge of
bottom, internal hex
connection and bone
level design.	Tapered implant body,
4 sided cutting edge of
bottom, internal hex
connection and bone
level design.
Fixture
diameter(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 and
16mm
Indication for use	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. | BioHorizons Laser-Lok
3.0 Implants 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. | The Peltop Narrow
Implant is indicated for
use in surgical and
restorative applications
for placement in the
mandibular central,
lateral incisor and
maxillary lateral
incisor regions of
partially edentulous
jaws where the
horizontal space is
limited by the adjacent
teeth and roots, to
provide support for
prosthetic devices,
such as artificial teeth,
in order to restore the
patient's chewing
function. The Paltop
Narrow Implant is
indicated also for
immediate loading
when good primary
stability is achieved
and with appropriate
occlusal loading. | 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
loading. Immediate
loading is restricted to
the anterior mandible
based on four splinted
interforminal placed
implants. | The Dentis 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
and not dedicated for
immediate loading.
This system is intended
for delayed loading. |
| Surface treatment | SLA | RBM | SLA | RBM | HA Coating |
| Principle of | Conventional procedure | Conventional procedure | Conventional | Conventional procedure | Conventional |

6

7

Operation	procedure	procedure
Anatomical Site	Oral cavity
mandibles and maxillae	Oral cavity
mandibles and maxillae	Oral cavity
mandibles and maxillae	Oral cavity
mandibles and maxillae	Oral cavity
mandibles and maxillae
Gamma sterilized	Yes	Yes	Yes	Yes	Yes
Abutment	Straight only	Straight and angled	Straight and angled
(20°)	Straight and angled
(30°)	Straight and
angled(25°)
Material
Composition of
Abutments	CP Titanium Grade 4,
Ti-6Al-4V ELI,
CCM Alloy,
Acetal, Gold	Titanium Alloy	Titanium Alloy	CP Titanium Grade 4
Ti-6Al-4V ELI,
CCM Alloy, Acetal	CP Titanium Grade 3
and 4
Ti-6Al-4V ELI,
PEEK, Gold, Acetal
Surface Treatment
of 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 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. | 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
loading. Immediate
loading is restricted to the anterior
mandible based on four splinted
interforminal placed implants. | The HAPTITE coating 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 and not dedicated
for immediate loading. This system is
intended 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) |

9

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, 13.6
mm (L)
Gold UCLA Abutment
Product Name	s-Clean Gold UCLA Abutment (Narrow)	MU Gold Cylinder	s-Clean GOLD UCLA Abutment
Materials	Gold/Acetal
Non coating	Gold/Acetal
Non coating	Gold/Acetal
Non 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) 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. | The Dentis Dental Implant system is an endosseous dental implant
that is indicated to use 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. Immediate loading is restricted to the anterior mandible,
based on four splinted interforminal placed implants, and not
indicated for single, unsplinted implants. | |
| Materials | Titanium Grade 4
Non coating | Titanium Grade 4
Non 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

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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K161244

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.