(88 days)
No
The device description and performance studies focus on the physical properties, materials, and mechanical testing of a dental implant fixture. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a dental implant intended to replace missing teeth, which falls under the definition of a therapeutic device as it treats a medical condition (edentulism).
No
Explanation: The device is described as a dental implant (fixture) intended to replace missing teeth, which is a therapeutic function, not a diagnostic one. Its purpose is to support restorations, not to diagnose a condition.
No
The device description clearly states it is a thread type implant made of Pure titanium, which is a physical hardware component. The summary also details physical dimensions and compatibility with other hardware components like abutments and cover screws.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a dental implant system used to replace missing teeth in the jawbone. This is a surgical device intended for implantation in the human body.
- Device Description: The description details the physical characteristics, material (titanium), dimensions, and surface treatment of the implant fixture. It also mentions compatibility with other dental components like abutments and cover screws.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
This device does not perform any tests on samples taken from the body. It is a physical implant placed within the body.
N/A
Intended Use / Indications for Use
Dentis s-Clean SQ-SL Fixture 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
Dentis s-Clean SQ-SL Fixture is two type as Mini and Regular according to the connection. Dentis s-Clean SQ-SL Fixture is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Hex.
The surface of fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching).
The dimensions of fixtures are as following:
| No. Device Name | Dimension Ranges |
|---|---|
| 1 s-Clean SQ-SL Fixture | Ø4.35, 4.8 and 5.2 (D) X 15.5 and 17.5mm |
| 2 s-Clean SQ-SL Fixture Mini | Ø3.7 and 4.1 (D) X 15.5 and 17.5 |
Tolerance of dimension shall be within ± 1% range.
s-Clean SQ-SL Fixture is compatible with devices in K192688 and K210134 as below:
| 510(K) | Abutment Name | Diameter(Ø) | Angulation | Length(mm) |
|---|---|---|---|---|
| K192688 | s-Clean Cover Screw | Ø3.6mm | 0 | 5.9mm |
| K192688 | s-Clen (TiN Half Coating) Sole Abutment S-Line | Ø4.5, 5.5, 6.5 and 7.5 | 0 | 11.6, 12.6 and 13.6 |
| K210134 | s-Celan (TiN Half Coating) Angled Abutment | Ø4.5 | 15 | 12.6 |
s-Clean SO-SL Fixture Mini is compatible with devices in K210080 as below:
| 510(K) | Abutment Name | Diameter(Ø) | Angulation | Length(mm) |
|---|---|---|---|---|
| K210080 | s-Clean Cover Screw Mini | Ø3.2mm | 0 | 5.0mm |
| K210080 | s-Clean Healing Abutment S- Line Mini | Ø4.3, 4.8 and 5.8 | 0 | 7.61, 8.61, 9.61, 10.61, 11.61, 12.61 and 14.61 |
| K210080 | s-Celan (TiN Half Coating) Sole Abutment Mini | Ø4.5 and 5.5 | 0 | 11.01, 12.01, 12.51, 13.01, 13.521, 14.01, 14.51, 15.01, 15.51, 16.01 and 17.01 |
| K210080 | s-Celan (TiN Half Coating) Couple Abutment Mini | Ø4.0, 4.5 and 5.5 | 0 | 8.35, 8.6, 9.35, 9.6, 9.85, 10.1, 10.35, 10.6, 11.1, 11.35, 11.6, 12.1, 12.85, 13.1, 13.35, 13.6, 14.35 and 14.6 |
| K210080 | s-Celan (TiN Half Coating) Angled Abutment Mini | Ø4.0 and 4.5 | 15 | 12.09, 12.34, 12.51 and 12.76 |
Denis s-Clean SQ-SL Fixture is provided sterilized.
Dentis s-Clean SQ-SL Fixture is packaged with Cover screw that was cleared in FDA as K192688 and K210080.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or fully edentulous 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:
- Fatigue Testing under the worst-case scenario according to ISO 14801:2016
- Sterilization Validation Test on Fixtures according to ISO 11137-1,2,3 referenced in K192688
- Shelf-Life Test on Fixtures according to ASTM F1980 referenced in K153639
- Biocompatibility testing on fixtures 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 on Fixtures according to ANSI/AAMI ST72:2011, USP , and USP referenced in K192688
Key Results: The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.
MR Environment Condition:
Non-clinical worst-case MRI review was performed to evaluate the metallic. Dentis s-Clean SQ-SL Fixture in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry 0., Jana G. Delfino, and Sunder Rajan. 'Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795)., based on the entire system including all variations (all compatible implant bodied, dental abutments and, fixation screws) and material composition. Rationale addressed parameters per the FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
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.
K140934, K153639, K202773, K210080, K210134, K222778
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.
May 20, 2024
Dentis Co., Ltd. % April Lee Regulatory Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K240511
Trade/Device Name: Dentis s-Clean SO-SL Fixture Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: February 21, 2024 Received: February 22, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 postmarketing 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 (QS) 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 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 mediation-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.
Sherrill Lathrop Blitzer
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices
2
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Dentis s-Clean SQ-SL Fixture
Indications for Use (Describe)
Dentis s-Clean SQ-SL Fixture 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.
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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4
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
Device Information
- Trade Name: Dentis s-Clean SQ-SL Fixture
- Common Name: implant, endosseous, root-form
- Classification Name: Endosseous dental implant
- Product Code: DZE ●
- Panel: Dental ●
- Regulation Number: 872.3640
- Device Class: Class II
- Date Prepared: 05/16/2024
Predicate Devices:
Primary and Reference Device
-
K192688, s-Clean SQ-SL Implant System Regular by Dentis Co., Ltd. .
Reference Device -
K140934, HIOSSEN Implant System manufactured by HIOSSEN, Incorporated
-
K153639, OneO-SL s-Clean Implant System by Dentis Co., Ltd. ●
-
K202773, S-Clean SQ-SL Implant System Mini by Dentis Co., Ltd.
-
K210080, Dentis s-Clean s-Line Mini by Dentis Co., Ltd. ●
-
K210134, Dentis s-Clean s-Line by Dentis Co., Ltd.
-
K222778, Osstem Implant System by Osstem Implant Co., Ltd. ●
Indications for Use:
Dentis s-Clean SQ-SL Fixture 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.
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
5
Device Description:
Dentis s-Clean SQ-SL Fixture is two type as Mini and Regular according to the connection. Dentis s-Clean SQ-SL Fixture is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Hex.
The surface of fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching).
The dimensions of fixtures are as following:
| No. | Device Name | Dimension Ranges |
|---|---|---|
| 1 | s-Clean SQ-SL Fixture | Ø4.35, 4.8 and 5.2 (D) X 15.5 and 17.5mm |
| 2 | s-Clean SQ-SL Fixture Mini | Ø3.7 and 4.1 (D) X 15.5 and 17.5 |
Tolerance of dimension shall be within ± 1% range.
s-Clean SQ-SL Fixture is compatible with devices in K192688 and K210134 as below:
| 510(K) | Abutment Name | Diameter(Ø) | Angulation | Length(mm) |
|---|---|---|---|---|
| K192688 | s-Clean Cover Screw | Ø3.6mm | 0 | 5.9mm |
| K192688 | s-Clen (TiN Half Coating) | |||
| Sole Abutment S-Line | Ø4.5, 5.5, 6.5 and | |||
| 7.5 | 0 | 11.6, 12.6 and 13.6 | ||
| K210134 | s-Celan (TiN Half Coating) | |||
| Angled Abutment | Ø4.5 | 15 | 12.6 |
s-Clean SO-SL Fixture Mini is compatible with devices in K210080 as below:
| 510(K) | Abutment Name | Diameter(Ø) | Angulation | Length(mm) |
|---|---|---|---|---|
| K210080 | s-Clean Cover Screw Mini | Ø3.2mm | 0 | 5.0mm |
| K210080 | s-Clean Healing Abutment S- | |||
| Line Mini | Ø4.3, 4.8 and 5.8 | 0 | 7.61, 8.61, 9.61, 10.61, 11.61, | |
| 12.61 and 14.61 | ||||
| K210080 | s-Celan (TiN Half Coating) | |||
| Sole Abutment Mini | Ø4.5 and 5.5 | 0 | 11.01, 12.01, 12.51, 13.01, | |
| 13.521, 14.01, 14.51, 15.01, | ||||
| 15.51, 16.01 and 17.01 | ||||
| K210080 | s-Celan (TiN Half Coating) | |||
| Couple Abutment Mini | Ø4.0, 4.5 and 5.5 | 0 | 8.35, 8.6, 9.35, 9.6, 9.85, 10.1, | |
| 10.35, 10.6, 11.1, 11.35, 11.6, | ||||
| 12.1, 12.85, 13.1, 13.35, 13.6, | ||||
| 14.35 and 14.6 | ||||
| K210080 | s-Celan (TiN Half Coating) | |||
| Angled Abutment Mini | Ø4.0 and 4.5 | 15 | 12.09, 12.34, 12.51 and 12.76 |
Denis s-Clean SQ-SL Fixture is provided sterilized.
Dentis s-Clean SQ-SL Fixture is packaged with Cover screw that was cleared in FDA as K192688 and K210080.
Materials:
- Dentis s-Clean SQ-SL Fixture is fabricated from Pure titanium of ASTM F67 .
6
Summaries of Technological Characteristics & Substantial Equivalence Discussion
s-Clean SQ-SL Fixture
| Subject Device | Primary Predicate | Reference Device | Predicate Device | |
|---|---|---|---|---|
| K240511 | K192688 | K140934 | K222778 | |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd | HIOSSEN Inc. | Osstem Implant CO., |
| Ltd. | ||||
| Trade Name | Dentis s-Clean SQ- | |||
| SL Fixture | s-Clean SQ-SL Implant | |||
| System Regular | HIOSSEN | |||
| IMPLANT SYSTEM | Osstem Implant | |||
| System | ||||
| Product | ||||
| Name | s-Clean SQ-SL | |||
| Fixture | s-Clean SQ-SL Fixture | ETII SA Fixture | TSIV SA Implant | |
| Design | ||||
| Indications | ||||
| for Use | Dentis s-Clean SQ-SL | |||
| Fixture 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 and not | ||||
| dedicated for immediate | ||||
| loading. This system is | ||||
| intended for delayed | ||||
| loading. | The HIOSSEN Implant | |||
| System is indicated for | ||||
| use in partially or fully | ||||
| edentulous mandibles | ||||
| and maxillae, in support | ||||
| of single or multipleunit | ||||
| restorations including; | ||||
| cemented retained, | ||||
| screw retained, or | ||||
| overdenture | ||||
| restorations, and final or | ||||
| temporary abutment | ||||
| support for fixed | ||||
| bridgework. It is | ||||
| intended for delayed | ||||
| loading. ETIII SA | ||||
| Ultra-Wide Fixture is | ||||
| intended to be used in | ||||
| the molar region. | The Osstem Implant | |||
| System is indicated for | ||||
| use in partially or fully | ||||
| edentulous mandibles | ||||
| and maxillae, in support | ||||
| of single or multiple- | ||||
| units restorations | ||||
| including; cemented | ||||
| retained, screw retained, | ||||
| or overdenture | ||||
| restorations, and final or | ||||
| temporary abutment | ||||
| support for fixed | ||||
| bridgework. It is | ||||
| intended for delayed | ||||
| loading. Ultra wide | ||||
| Implant system is | ||||
| intended to be used in | ||||
| the molar region. | ||||
| Products with diameter | ||||
| or less than 3.25mm | ||||
| should be used | ||||
| exclusively for the | ||||
| lateral incisor in the | ||||
| maxilla and a central or | ||||
| lateral incisor in the | ||||
| mandible. | ||||
| Diameter and | ||||
| Length | Ø4.35 x 15.5, | |||
| 17.5mm | ||||
| Ø4.8 x 15.5, 17.5mm | ||||
| Ø5.2 x 15.5, 17.5mm | Ø4.1 x 7, 7.5, 9.5, 11.5, | |||
| 13.5mm | ||||
| Ø4.35 x 7, 7.5, 9.5, | ||||
| 11.5, 13.5mm | ||||
| Ø4.8 x 7, 7.5, 9.5, 11.5, | ||||
| 13.5mm | ||||
| Ø5.8 x 7, 7.5, 9.5, | ||||
| 11.5mm | ||||
| Ø6.8 x 7, 7.5, 9.5, | ||||
| 11.5mm | ||||
| Ø7.8 x 7, 7.5, 9.5, | ||||
| 11.5mm | Ø3.5 x 8.7, 10.2,11.7, | |||
| 13.2, 15.2, 18.2mm | ||||
| Ø4.2 x 7.2, 8.7, 10.2, | ||||
| 11.7, 13.2, 15.2, | ||||
| 18.2mm | ||||
| Ø4.45 x 7.2, 8.7,10.2, | ||||
| 11.7, 13.2, 15.2mm | ||||
| Ø5.0x 6.2mm | ||||
| Ø4.9 x 7.2, 8.7, 10.2, | ||||
| 11.7, 13.2, 15.2mm | Ø4.4 x 18mm | |||
| Ø4.8 x 18mm | ||||
| Ø5.25 x 18mm | ||||
| Surface | ||||
| Treatment | SLA | SA | SA | |
| Material | CP Titanium Gr4 | |||
| (ASTM F67) | CP Titanium Gr4 | |||
| (ASTM F67) | CP Titanium Gr4 | |||
| (ASTM F67) | CP Titanium Gr4 | |||
| (ASTM F67) | ||||
| Sterilization | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation |
| Shelf Life | 8years | 8years | 8years | 8years |
| Comparison | The Subject Device and primary device, K192688 have same characteristics such as indications | |||
| for Use, design, surface treatment, material, sterilization, and shelf life. The difference between | ||||
| subject device and primary predicate is dimension. The subject device has longer lengths fixtures, | ||||
| such as 15.5 and 17.5mm. To support this difference, K140934 and K222778 were added | ||||
| because the dimension combination of two devices covers all range of the subject device's | ||||
| dimensions. |
7
s-Clean SQ-SL Fixture Mini
| Subject Device | Reference Device | Reference Device | ||
|---|---|---|---|---|
| K number | K240511 | K202773 | K140934 | |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd | HIOSSEN Inc. | |
| Trade Name | Dentis s-Clean SQ-SL | |||
| Fixture | s-Clean SQ-SL Implant | |||
| System Mini | Osstem Implant System | |||
| Product Name | s-Clean SQ-SL Mini | s-Clean SQ-SL Mini Fixture | ETII SA Fixture | |
| Design | Image: Dentis s-Clean SQ-SL Fixture | Image: s-Clean SQ-SL Implant System Mini | Image: ETII SA Fixture | |
| Indications for | ||||
| Use | Dentis s-Clean SQ-SL Fixture | |||
| 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 | |||
| Mini 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. | The HIOSSEN Implant System is | |||
| indicated for use in partially or fully | ||||
| edentulous mandibles and maxillae, | ||||
| in support of single or multipleunit | ||||
| restorations including; cemented | ||||
| retained, screw retained, or | ||||
| overdenture restorations, and final or | ||||
| temporary abutment support for fixed | ||||
| bridgework. It is intended for delayed | ||||
| loading. ETIII SA Ultra-Wide Fixture | ||||
| is intended to be used in the molar | ||||
| region. | ||||
| Diameter and | ||||
| Length | $Ø3.7 x 15.5, 17.5mm$ | |||
| $Ø4.17 x 15.5, 17.5mm$ | $Ø3.7 x 7.5, 9.5, 11.5, 13.5mm$ | |||
| $Ø4.1 x 7.5, 9.5, 11.5, 13.5mm$ | $Ø3.5 x 8.7, 10.2, 11.7, 13.2, 15.2,$ | |||
| $18.2mm$ | ||||
| $Ø4.2 x 7.2, 8.7, 10.2, 11.7, 13.2,$ | ||||
| $15.2, 18.2$ | ||||
| $Ø4.45 x 7.2, 8.7, 10.2, 11.7, 13.2,$ | ||||
| $15.2mm$ | ||||
| $Ø5.0x 6.2mm$ | ||||
| $Ø4.9 x 7.2, 8.7, 10.2, 11.7, 13.2,$ | ||||
| $15.2mm$ | ||||
| Surface | ||||
| Treatment | SLA | SLA | SA | |
| Material | CP Titanium Gr4 (ASTM | |||
| F67) | CP Titanium Gr4 (ASTM | |||
| F67) | CP Titanium Gr4 (ASTM F67) | |||
| Sterilization | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation | |
| Shelf Life | 8years | 8years | 8years | |
| Comparison | The Subject Device and reference device, K202773 have same characteristics such as indications | |||
| for Use, design (dual screw joint), surface treatment, material, sterilization, and shelf life. The | ||||
| difference between the two devices is dimension. To support this difference, K140934 was added | ||||
| because the dimension combination of K140934 covers all range of the subject device's | ||||
| dimensions. |
8
Non-Clinical Test Data
Below tests were performed on subject device:
-
Fatigue Testing under the worst-case scenario according to ISO 14801:2016
Below tests were performed for predicate devices and leveraged for the subject device: -
Sterilization Validation Test on Fixtures according to ISO 11137-1,2,3 referenced in K192688 ●
-
. Shelf-Life Test on Fixtures according to ASTM F1980 referenced in K153639
-
. Biocompatibility testing on fixtures 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 on 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.
Non-clinical test data was conducted in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments". Clinical testing was not necessary to establish substantial equivalency of the device.
The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.
MR Environment Condition
Non-clinical worst-case MRI review was performed to evaluate the metallic. Dentis s-Clean SQ-SL Fixture in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry 0., Jana G. Delfino, and Sunder Rajan. 'Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795)., based on the entire system including all variations (all compatible implant bodied, dental abutments and, fixation screws) and material composition. Rationale addressed parameters per the FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
Conclusion
Dentis s-Clean SO-SL Fixture 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, Dentis s-Clean SQ-SL Fixture and its predicates are substantially equivalent.