(29 days)
No
The document describes a dental implant system and its physical characteristics, materials, and testing. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes
This device is a dental implant system used to replace missing teeth and support dental restorations, which acts as a therapeutic intervention for patients with edentulous mandibles and maxillae.
No
Explanation: The device is an implant system used to replace missing teeth, not to diagnose a condition. Its indications for use and device description confirm its function as a prosthetic device.
No
The device description clearly states it is a physical implant made of titanium, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use in the mouth (mandibles and maxillae) to support dental restorations. This is a surgical implant, not a device used to examine specimens from the human body.
- Device Description: The description details a physical implant made of titanium that is placed in bone. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
The device described is a dental implant system, which is a type of medical device used in surgery.
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 (comma separated list FDA assigned to the subject device)
DZE
Device Description
This submission is to add new implants to the previously cleared device, s-Clean SQ-SL Implant System Regular (K192688). The newly added implant is "s-Clean SQ-SL Fixture with Ø5.2mm diameter".
The s-Clean SQ-SL Implant System Regular is composed of a fixture and cover screw. The s-Clean SQ-SL Fixture is a thread-type implant made of Commercial Pure Titanium Grade 4 according to ASTM F67 which is placed in the alveolar bone to replace the function of the missing tooth. This device has a connection between the upper prosthesis and the internal Hex.
The Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is the only part to be implanted into bone, to provide connection of prosthetic devices or other components of a dental implant set within the human body (mandibular or maxillary bone). The dimensions are as follows:
| Device Name | Diameter (mm) | Length (mm) |
|---|---|---|
| s-Clean SQ-SL | ||
| Fixture | $ 5.2 $ | 7.0, 7.5, 9.5, 11.5, 13.5 |
The fixture is packaged with a cover screw cleared under K192688. The fixture is provided sterile.
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)
No new non-clinical testing was performed for the subject device since the subject device compared to the predicate device are substantially equivalent in indications, fundamental technology, material, and design. Any testing provided in the predicate device may be leveraged for the subject device of using the same materials, manufacturing methods, and sterilization procedures. Although the diameters are slightly different, it does not impact the ability to determine substantial equivalence of the subject device because the diameter of the subject device is within the range of diameters of the primary predicate.
The tests below were performed for the predicate devices and leveraged for the subject device:
- Sterilization Validation Test for subject fixtures according to ISO 11137-1, 2, 3 referenced in K192688
- Shelf Life Test for subject fixtures according to ASTM F1980 referenced in K153639
- 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 referenced in K153639
- Bacterial Endotoxin Test Report for subject fixtures according to ANSI/AAMI ST72:2011, USP , and USP referenced in K192688
The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.
The surface modification information with SLA (Sandblasted with Large-grit and Acid-etching) was provided. To compare surface modification between the subject and predicate devices, K153639, surface roughness, surface composition analysis, and SEM imaging were provided and it demonstrated substantial equivalence.
The fatigue testing per ISO 14801 was not conducted as the subject device is not compatible with any angled abutments.
Non-clinical tests followed the recommendations in the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
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.
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.
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
§ 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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo 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.
Dentis Co., Ltd. % April Lee Consultant Withus Group Inc. 106 Superior Irvine, California 92620
Re: K210132
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 Dated: January 8, 2021 Received: January 19, 2021
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 Part 803) for devices or post-marketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 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.
Andrew Steen Assistant 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) K210132
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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image contains the word "DENTIS" in bold, black letters. To the left of the word is an orange graphic that resembles a flame or a stylized letter "d". The graphic is a gradient of orange, with the darkest shade at the bottom and the lightest at the top.
- Plant 1: 99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Plant 2: 6, Yuram-ro, Dong-gu, Daegu, Korea Tel: 82.53.582.2804 / Fax: 82.53.583.2806
510(k) Summary K210132
●
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
- Panel: Dental
- Regulation Number: 872.3640
- Device Class: Class II ●
- Date Prepared: 01/08/2021
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
- . K192688, s-Clean SQ-SL Implant System Regular by Dentis Co., Ltd.
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.
Device Description:
This submission is to add new implants to the previously cleared device, s-Clean SQ-SL Implant System Regular (K192688). The newly added implant is "s-Clean SQ-SL Fixture with Ø5.2mm diameter".
The s-Clean SQ-SL Implant System Regular is composed of a fixture and cover screw. The s-Clean SQ-SL Fixture is a thread-type implant made of Commercial Pure Titanium Grade 4 according to ASTM F67
4
Image /page/4/Picture/1 description: The image contains the word "DENTIS" in bold, sans-serif font. To the left of the word is an orange, abstract graphic. The graphic is curved and has a gradient effect, with the color transitioning from a lighter orange to a darker orange.
Plant 1: 99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Plant 2: 6, Yuram-ro, Dong-gu, Daegu, Korea . Tel: 82.53.582.2804 / Fax: 82.53.583.2806
which is placed in the alveolar bone to replace the function of the missing tooth. This device has a connection between the upper prosthesis and the internal Hex.
.
The Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is the only part to be implanted into bone, to provide connection of prosthetic devices or other components of a dental implant set within the human body (mandibular or maxillary bone). The dimensions are as follows:
| Device Name | Diameter (mm) | Length (mm) |
|---|---|---|
| s-Clean SQ-SL | ||
| Fixture | $ 5.2 $ | 7.0, 7.5, 9.5, 11.5, 13.5 |
The fixture is packaged with a cover screw cleared under K192688. The fixture is provided sterile.
Materials:
The Fixture is fabricated from CP Titanium Grade 4 (Conforming to ASTM Standard F67).
Summaries of Technology Characteristics:
| Subject Device | Primary Predicate Device | |
|---|---|---|
| K number | K210132 | K192688 |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd |
| Trade Name | s-Clean SQ-SL Implant Regular System | s-Clean SQ-SL Implant Regular System |
| Description | Image: s-Clean SQ-SL Implant Regular System | Image: s-Clean SQ-SL Implant Regular System |
| 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, | ||
| screw retained, or overdenture restorations, | ||
| and terminal or intermediate abutment | ||
| support for fixed bridgework. This system | ||
| is dedicated for one- and two-stage | ||
| surgical procedures. This system is | ||
| intended for delayed loading. | 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. This system is intended for | ||
| delayed loading. | ||
| Diameter (mm) | ⌀5.2 | ⌀4.1, 4.35, 4.8, 5.8, 6.8, 7.8 |
| Length (mm) | 7, 7.5, 9.5, 11.5, 13.5 | 7, 7.5, 9.5, 11.5, 13.5 |
| Surface Treatment | SLA | SLA |
| Material | CP Titanium Gr. 4 (ASTM F67) | CP Titanium Gr. 4 (ASTM F67) |
| Sterilization | Gamma irradiation | Gamma irradiation |
| Shelf Life | 8 years | 8 years |
-
- s-Clean SQ-SL Fixture
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Image /page/5/Picture/0 description: The image shows the logo for DENTIS. The logo features an orange abstract shape to the left of the word "DENTIS", which is written in a bold, sans-serif font. The abstract shape appears to be a stylized letter "D" or a flame-like design. The overall design is simple and modern.
| Plant 1: | 99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea |
|---|---|
| Plant 2: | 6, Yuram-ro, Dong-gu, Daegu, Korea |
| Tel: | 82.53.582.2804 / Fax: 82.53.583.2806 |
| Comparison | The subject device and the primary predicate device have the same characteristics such as
Indications for Use, design, length, surface treatment, material, abutment connection, and
sterilization method. The difference between the two devices is the diameter. Since the
diameter of the subject device is in range of the diameters of the primary predicate, it does
not affect product performance. Therefore, the subject device is substantially equivalent. |
| ------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
●
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Image /page/6/Picture/1 description: The image contains the word "DENTIS" in bold, black font. To the left of the word is an orange graphic that resembles a stylized flame or a curved shape with a circle inside. The overall impression is a logo or brand name.
Plant 1: 99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea ● Plant 2: 6, Yuram-ro, Dong-gu, Daegu, Korea Tel: 82.53.582.2804 / Fax: 82.53.583.2806
Non-Clinical Test Data
No new non-clinical testing was performed for the subject device since the subject device compared to the predicate device are substantially equivalent in indications, fundamental technology, material, and design. Any testing provided in the predicate device may be leveraged for the subject device of using the same materials, manufacturing methods, and sterilization procedures. Although the diameters are slightly different, it does not impact the ability to determine substantial equivalence of the subject device because the diameter of the subject device is within the range of diameters of the primary predicate.
The tests below were performed for the predicate devices and leveraged for the subject device:
- Sterilization Validation Test for subject fixtures according to ISO 11137-1, 2, 3 referenced in K192688
- Shelf Life Test for subject fixtures according to ASTM F1980 referenced in K153639 ●
- 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 referenced in K153639
- . Bacterial Endotoxin Test Report for subject fixtures according to ANSI/AAMI ST72:2011, USP , and USP referenced in K192688
The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.
The surface modification information with SLA (Sandblasted with Large-grit and Acid-etching) was provided. To compare surface modification between the subject and predicate devices, K153639, surface roughness, surface composition analysis, and SEM imaging were provided and it demonstrated substantial equivalence.
The fatigue testing per ISO 14801 was not conducted as the subject device is not compatible with any angled abutments.
Non-clinical tests followed the recommendations in the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
Conclusion
The s-Clean SQ-SL Implant System Regular constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, the s-Clean SO-SL Implant System Regular is substantially equivalent.