(131 days)
No
The summary describes a dental implant system made of titanium with a specific surface treatment. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies listed are standard non-clinical tests for medical devices.
Yes
The device, an implant system, is used to replace missing teeth and support restorations in the human body, indicating a therapeutic purpose.
No
This device is a dental implant system used for restorative dentistry (replacing missing teeth), not for diagnosing medical conditions.
No
The device description explicitly states it is composed of a "Fixture and Abutments" made of "Commercial Pure Titanium Grade 4" and is "to be implanted into bone," indicating it is a physical implant system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in the body to support dental restorations. IVDs are used outside the body to examine specimens (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The device is an implant system made of titanium that is placed in the bone. This is a surgical implant, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information about a patient's condition.
This device is clearly a medical device, specifically a dental implant system, intended for surgical placement and support of dental prosthetics.
N/A
Intended Use / Indications for Use
s-Clean SQ-SL Implant System Regular 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.
Product codes
DZE, NHA
Device Description
s-Clean SQ-SL Implant System Regular is composed of Fixture and Abutments. s-Clean SQ-SL Fixture is a thread type implant made of Commercial Pure Titanium Grade 4 according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. The device has an internal connection between the implant body and the abutment component.
Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching).
The implant body is the only part to be implanted into bone (mandibular or maxillary bone), and is to be connected to the abutment.
The dimensions are as following:
| Name | Diameter (mm) | Length (mm) |
|---|---|---|
| s-Clean SQ-SL Fixture | Ø4.1/Ø4.35/Ø4.8 | 7.0, 7.5, 9.5, 11.5, 13.5 |
| s-Clean SQ-SL Fixture | Ø5.8/Ø6.8/Ø7.8 | 7.0, 7.5, 9.5, 11.5 |
Abutments are composed as below;
s-Clean Sole Abutment S-Line, s-Clean TiN Half Coating Sole Abutment S-Line, and s-Clean Cover Screw.
The dimensions of abutments are as following:
| No. | Device Name | Dimensions | Angulation |
|---|---|---|---|
| 1 | s-Clean Sole Abutment S-Line | Ø4.5, 5.5, and 6.5 mm(D) X 1.8, 2.8 and 3.8mm (Gingival Height) X 4.0mm (Post Height) | 0° |
| 2 | s-Clean TiN Half Coating Sole Abutment S-Line | Ø4.5, 5.5, and 6.5 mm (D) X 1.8, 2.8 and 3.8mm (Gingival Height) X 4.0mm (Post Height) | 0° |
| 3 | s-Clean Cover Screw | Ø3.6mm (D) X 5.9mm (L) | 0° |
The Abutments have below featured:
| Name | Uses | Surface | Connection |
|---|---|---|---|
| s-Clean Sole Abutment S-Line | The Abutment is connected with fixture and it supports prosthesis which restores tooth function. | N/A | Internal Hex |
| s-Clean TiN Half Coating Sole Abutment S-Line | TiN-Coating | Internal Hex | |
| s-Clean Cover Screw | It is used for protecting inner hole and connecting part with exposed upper part of structure during the healing period after inserting dental implant fixture | N/A | Screw Retained |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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:
The subject device was tested to evaluate its substantial equivalence according to the following standards.
- Bacterial Endotoxin Test Report on Subject Fixture according to ANSI/AAMI ST72:2011, USP , and USP
- Shelf Life Test for subject fixtures according to ASTM F1980
Below tests were performed for predicate devices and leveraged for the subject device:
- Sterilization Validation Test for subject fixtures according to ISO 11137-1,2,3 referenced in K153639
- Sterilization Validation Test on s-Clean Healing Abutment for subject Cover Screw according to ISO 11137-1,2,3 referenced in K171027
- Shelf Life Test on s-Clean Healing Abutment for subject Cover Screw according to ISO 11137-1,2,3 referenced in K171027
- End User Sterilization Validation Test Report for subject abutments according to ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1 referenced in K171027
- Biocompatibility testing according to ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 on fixtures referenced in K153639
- Biocompatibility testing according to ISO 10993-1:2009 on machined surface abutments referenced in K171027.
- Biocompatibility testing according to ISO 10993-3:2014. ISO 10993-5:2009. ISO 10993-10:2010, and ISO 10993-11:2006 ISO on s-Clean TiN Coating Abutments in K171694
- Biocompatibility Testing according to ISO 10993-1:2009 on Cover Screw referenced in K171027.
The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device. The fatigue testing per ISO 14801 was not conducted as it is not necessary based on the device-specific guidance document.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 4, 2020
Dentis Co., Ltd. % April Lee Consultant Withus Group Inc. 106 Superior Irvine, California 92620
Re: K192688
Trade/Device Name: s-Clean SQ-SL Implant System Regular Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 2, 2019 Received: November 12, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192688
Device Name s-Clean SQ-SL Implant System Regular
Indications for Use (Describe)
s-Clean SQ-SL Implant System Regular 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/1 description: The image shows the word "DENTIS" in bold, black letters. To the left of the word is an orange, abstract symbol that resembles a stylized flame or a curved shape with a circular element. The logo appears to be for a company or organization named "DENTIS."
Dentis Co., Ltd
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806
510(K) Summary
Submitter
Dentis Co., Ltd. Gyu Ri Kim 99, Seongseoseo-ro, Dalseo-gu Daegu, 42718 Korea Email: kgr1026@dentis.co.kr Tel. +82-53-589-3541 Fax. +82-53-289-7922
Official Correspondent
Withus Group Inc. April Lee 106 Superior, Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122
Device Information
- Trade Name: s-Clean SQ-SL Implant System Regular
- Common Name: Dental Implant System
- Classification Name: implant, endosseous, root-form
- Product Code: DZE
- . Secondary Product Code: NHA
- Panel: Dental
- Regulation Number: 21 CFR 872.3640
- Device Class: Class II ●
- Date Prepared: 01/28/2020
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
- K153639, OneQ-SL s-Clean Implant System by Dentis Co., Ltd. ●
Reference Predicates
- K171027, Dentis Dental Implant System by Dentis Co., Ltd.
- K171694, s-Clean TiN Coating Abutments by Dentis Co., Ltd.
Indication for Use:
s-Clean SQ-SL Implant System Regular 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.
4
Image /page/4/Picture/1 description: The image shows the word "DENTIS" in bold, black font. To the left of the word is an orange graphic that resembles a flame or a stylized letter "D". The graphic is a gradient, with the bottom being a darker orange and the top being a lighter orange.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806
Device Description:
s-Clean SQ-SL Implant System Regular is composed of Fixture and Abutments. s-Clean SQ-SL Fixture is a thread type implant made of Commercial Pure Titanium Grade 4 according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. The device has an internal connection between the implant body and the abutment component.
Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching).
The implant body is the only part to be implanted into bone (mandibular or maxillary bone), and is to be connected to the abutment.
The dimensions are as following:
| Name | Diameter (mm) | Length (mm) |
|---|---|---|
| s-Clean SQ-SL Fixture | Ø4.1/Ø4.35/Ø4.8 | 7.0, 7.5, 9.5, 11.5, 13.5 |
| s-Clean SQ-SL Fixture | Ø5.8/Ø6.8/Ø7.8 | 7.0, 7.5, 9.5, 11.5 |
Abutments are composed as below;
s-Clean Sole Abutment S-Line, s-Clean TiN Half Coating Sole Abutment S-Line, and s-Clean Cover Screw.
The dimensions of abutments are as following:
| No. | Device Name | Dimensions | Angulation |
|---|---|---|---|
| 1 | s-Clean Sole Abutment | ||
| S-Line | Ø4.5, 5.5, and 6.5 mm(D) X 1.8, 2.8 and 3.8mm | ||
| (Gingival Height) X 4.0mm (Post Height) | 0° | ||
| 2 | s-Clean TiN Half Coating | ||
| Sole Abutment S-Line | Ø4.5, 5.5, and 6.5 mm (D) X 1.8, 2.8 and 3.8mm | ||
| (Gingival Height) X 4.0mm (Post Height) | 0° | ||
| 3 | s-Clean Cover Screw | Ø3.6mm (D) X 5.9mm (L) | 0° |
The Abutments have below featured:
| Name | Uses | Surface | Connection |
|---|---|---|---|
| s-Clean Sole Abutment S- | |||
| Line | The Abutment is connected with fixture | ||
| and it supports prosthesis which restores | |||
| tooth function. | N/A | Internal Hex | |
| s-Clean TiN Half Coating | |||
| Sole Abutment S-Line | TiN-Coating | Internal Hex | |
| s-Clean Cover Screw | It is used for protecting inner hole and | ||
| connecting part with exposed upper part | |||
| of structure during the healing period after | |||
| inserting dental implant fixture | N/A | Screw Retained |
5
Dentis Co., Ltd.
Image /page/5/Picture/1 description: The image contains the logo for DENTIS. The logo features an orange circular design on the left, followed by the word "DENTIS" in a bold, sans-serif font. The overall design is simple and professional.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806
Materials:
- The s-Clean SQ-SL Fixture and s-Clean Cover Screw are fabricated from Commercial Pure Titanium . Grade 4 of ASTM F67
- . The s-Clean Sole Abutment S-Line and s-Clean TiN Half Coating Sole Abutment S-Line are fabricated from Ti-6Al-4V ELI of ASTM F136
Summaries of Technology Characteristics:
s-Clean SQ-SL Fixture
| Subject Device | Primary Predicate Device | |
|---|---|---|
| 510(k) Number | N/A | K153639 |
| Trade Name | s-Clean SQ-SL Implant System Regular | OneQ-SL s-Clean Implant System |
| Manufacturer | Dentis Co., Ltd. | Dentis Co., Ltd. |
| Design | ||
| (Fixture Type) | Image: Two implants |
- Internal Hex-connected
- Submerged Fixture
- Bone level
- Tapered body
- cutting edge with self-tapping | Image: Two implants
- Internal Hex-connected
- Submerged Fixture
- Bone Level
- Tapered & Straight Body
- 3 sided cutting edge with self-tapping |
| Fixture Diameter(Ø) | Regular: 4.1, 4.35, 4.8
Wide: 5.8, 6.8, 7.8 | Regular: 3.7,3.9,4.2,4.7,5.2
Wide: 6.0,7.0,8.0 |
| Fixture Length | Regular: 7,7.5,9.5,11.5,13.5mm
Wide: 7,7.5,9.5,11.5mm | Regular: 7,8,10,12,14mm
Wide: 7,8,10,12mm |
| Indication for Use | s-Clean SQ-SL Implant System Regular 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. | 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 and not dedicated for
immediate loading. This system is intended for
delayed loading. |
| Surface Treatment | SLA | SLA |
| Material | CP Titanium Grade 4 | CP Titanium Grade 4 |
| | (ASTM F67) | (ASTM F67) |
| Similarities | s-Clean SQ-SL Implant System Regular has similar device characteristics with the
Primary predicate devices, OneQ-SL s-Clean Implant System (K153639) such as Length,
material, functions, general shape (Design), manufacturing process, and surface treatment
are similar. The indications for Use are identical between two devices and that other
reference devices used in this submission do not include any component-specific
language that would be needed in the subject Indications for Use. | |
| Differences | The differences are the macro shape of the implant body and small differences in the
dimensions proposed; we have provided all descriptive information related to shape and
the primary predicate includes the subject device range of dimensions. Therefore, these
differences do not impact substantial equivalence. | |
6
Image /page/6/Picture/0 description: The image shows the word "DENTIS" in bold, black letters. To the left of the word is an orange graphic that resembles a stylized flame or swirl. The overall impression is that of a logo or brand name.
Dentis Co., Ltd.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea
s-Clean Sole Abutment S-Line
| Subject Device | Reference Device | |
|---|---|---|
| 510(k) Number | N/A | K171027 |
| Trade Name | s-Clean SQ-SL Implant System Regular | Dentis Dental Implant System |
| Manufacturer | Dentis Co., Ltd. | Dentis Co., Ltd. |
| Product Name | s-Clean Sole Abutment S-Line | s-Clean Sole Abutment |
| Design | Image: s-Clean Sole Abutment S-Line | Image: s-Clean Sole Abutment |
| Dimension | Ø4.5: 11.6, 12.6, 13.6mm | |
| Ø5.5: 11.6, 12.6, 13.6mm | ||
| Ø6.5: 11.6, 12.6, 13.6mm | Ø4.5: 12.5 – 17mm | |
| Ø4.8: 12 – 17mm | ||
| Ø5.5: 12.5 – 17mm | ||
| Ø6.0: 13 – 17mm | ||
| Ø6.5: 12.5 – 17mm | ||
| Angulation | N/A | N/A |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) |
| Brief Comparison | The general design is similar to the reference device; the differences are minor | |
| differences in design and dimensions, though the subject device range of dimensions is | ||
| included in the reference device. The apparently smaller total length does not impact | ||
| substantial equivalence as the post height is at least 4mm, which is clinically | ||
| recommended. |
7
Image /page/7/Picture/0 description: The image shows the logo for DENTIS. The logo consists of an orange abstract shape on the left and the word "DENTIS" in black bold letters on the right. The abstract shape appears to be a stylized flame or a curved shape with a gradient of orange colors.
Dentis Co., Ltd
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806
| Subject Device | Reference Device | |
|---|---|---|
| 510(k) Number | N/A | K171694 |
| Trade Name | s-Clean SQ-SL Implant System Regular | s-Clean TiN Coating Abutments |
| Manufacturer | Dentis Co., Ltd. | Dentis Co., Ltd. |
| Product Name | s-Clean TiN Half Coating Sole Abutment S- | |
| Line | s-Clean TiN Partial Coating Sole Abutment | |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Dimension | Ø4.5: 11.6, 12.6, 13.6mm | |
| Ø5.5: 11.6, 12.6, 13.6mm | ||
| Ø6.5: 11.6, 12.6, 13.6mm | Ø4.5: 8.8 - 13.3mm | |
| Ø4.8: 9.3 - 13.3mm | ||
| Ø5.5: 8.8 - 13.3mm | ||
| Ø6.0: 9.3 - 13.3mm | ||
| Ø6.5: 8.8 - 13.3mm | ||
| Angulation | N/A | N/A |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) |
| Coating | TiN Coating | TiN Coating |
| Brief Comparison | The general design is similar to the reference device; the differences are minor differences in | |
| design and dimensions, though the subject device range of dimensions is included in the | ||
| reference device. The apparently smaller total length does not impact substantial equivalence as | ||
| the post height is at least 4mm, which is clinically recommended. |
s-Clean TiN Half Coating Sole Abutment S-Line
Substantial Equivalence Discussion
Similarities:
s-Clean SQ-SL Implant System Regular has similar device characteristics with the Primary predicate devices, OneQ-SL s-Clean Implant System (K153639) such as Length, material, functions, general shape (Design), manufacturing process, and surface treatment are similar. The indications for Use are identical between two devices and that other reference devices used in this submission do not include any component-specific language that would be needed in the subject Indications for Use.
Differences:
The differences are the macro shape of the implant body and small differences in the dimensions proposed; we have provided all descriptive information related to shape and the predicates include the subject device range of dimensions. Therefore, these differences do not impact substantial equivalence.
8
Image /page/8/Picture/0 description: The image shows the logo for DENTIS. The logo consists of an orange abstract shape on the left and the word "DENTIS" in black on the right. The abstract shape appears to be a stylized letter "D" or a flame-like design.
Dentis Co., Ltd
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806
Non-Clinical Test Data
The subject device was tested to evaluate its substantial equivalence according to the following standards.
- Bacterial Endotoxin Test Report on Subject Fixture according to ANSI/AAMI ST72:2011, USP ● , and USP
- . Shelf Life Test for subject fixtures according to ASTM F1980
Below tests were performed for predicate devices and leveraged for the subject device:
- . Sterilization Validation Test for subject fixtures according to ISO 11137-1,2,3 referenced in K153639
- Sterilization Validation Test on s-Clean Healing Abutment for subject Cover Screw according ● to ISO 11137-1,2,3 referenced in K171027
- Shelf Life Test on s-Clean Healing Abutment for subject Cover Screw according to ISO ● 11137-1,2,3 referenced in K171027
- End User Sterilization Validation Test Report for subject abutments according to ANSI/AAMI . ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1 referenced in K171027
- Biocompatibility testing according to ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-. 5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 on fixtures referenced in K153639
- . Biocompatibility testing according to ISO 10993-1:2009 on machined surface abutments referenced in K171027.
- . Biocompatibility testing according to ISO 10993-3:2014. ISO 10993-5:2009. ISO 10993-10:2010, and ISO 10993-11:2006 ISO on s-Clean TiN Coating Abutments in K171694
- . Biocompatibility Testing according to ISO 10993-1:2009 on Cover Screw referenced in K171027.
The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device. The fatigue testing per ISO 14801 was not conducted as it is not necessary based on the device-specific guidance document
The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.
Conclusion
s-Clean SQ-SL Implant System Regular constitutes a substantially equivalent medical device. This system has the same intended use and fundamental scientific technology as its predicate devices. Any additional small differences do not impact substantial equivalence. Therefore, s-Clean SO-SL Implant System Regular and its predicates are substantially equivalent.