(158 days)
No
The summary describes a system of physical dental abutments and screws, with no mention of software, image processing, or AI/ML terms. The performance studies are focused on mechanical and biological properties.
No
The device is described as an aid in prosthetic restoration, supporting single or multiple unit restorations and fixed bridgework, which are restorative rather than therapeutic functions.
No
The device description states it is "intended for use as an aid in prosthetic restoration" and consists of "Abutments and Abutment screws," which are components for dental implants, not for diagnosing conditions.
No
The device description explicitly states it consists of "Abutments and Abutment screws," which are physical hardware components. The performance studies also detail testing on materials like PEEK, CCM, and Ti-6Al-4V ELI, further indicating a hardware-based device.
Based on the provided information, the Dentis i-Clean System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for supporting dental restorations in the mandibles and maxillae. IVDs are used in vitro (outside the body) to examine specimens derived from the human body.
- Device Description: The device consists of abutments and abutment screws, which are physical components implanted or attached within the mouth. This is consistent with a medical device used in vivo, not an IVD.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
Therefore, the Dentis i-Clean System is a medical device used for dental restoration support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Dentis i-Clean 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. This system is intended for delayed loading.
Product codes
NHA
Device Description
Dentis i-Clean system is intended for use as an aid in prosthetic restoration. It consists of Abutments and Abutment screws.
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:
- Fatigue Testing under the worst-case scenario according to ISO 14801:2016
- End user Sterilization Validation for Abutment made of PEEK and CCM materials according to ISO 17665-1,-2, and ISO 11737-1.
Below tests were performed for predicate devices and leveraged for the subject device:
- End User Sterilization Validation for Abutments made of Ti-6AI-4V ELI according to ISO 17665-1,-2, and ISO 11737-1 referenced in K111364
- Biocompatibility testing on Abutments made of Ti-6Al-4V ELI according to ISO 10993-1:2009 referenced in K171027 and K150344
- Biocompatibility testing on Abutments made of PEEK and CCM according to ISO 10993-1:2009 referenced in K171027
The Biocompatibility test was conducted on the predicate device and leveraged for the subject device because both products are manufactured with the same materials and manufacturing process. It demonstrates that the subject device is substantially equivalent with the predicate.
MR Environment Condition:
Non-clinical worst-case MRI review was performed to evaluate the metallic devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., 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 bodies, 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)
Reference Device(s)
K111364, K150344, K171027, K173120, K181137
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
7/11/2023
Dentis Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K230307
Trade/Device Name: Dentis i-Clean System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: June 11, 2023 Received: June 12, 2023
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 (QS) 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.
Sherrill Lathrop Blitzer
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230307
Device Name Dentis i-Clean System
Indications for Use (Describe)
Dentis i-Clean System 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
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 i-Clean System ●
- Common Name: Dental Implant System
- Classification Name: Endosseous dental implant abutment ●
- Product Code: NHA
- . Panel: Dental
- Regulation Number: 872.3630
- Device Class: Class II
- Date Prepared: 07/10/2023
Predicate Devices:
Primary Predicate
- K210134, Dentis s-Clean s-Line by Dentis Co., Ltd. ●
Reference devices
- K111364, HAPTITE COATING IMPLANT SYSTEM by Dentis Co., Ltd. ●
- K150344, Dentis Dental Implant System by Dentis Co., Ltd. ●
- K171027, Dentis Dental Implant System manufactured by Dentis Co., Ltd. ●
- K173120, CCM Abutment System by InnoBiosSurg Co., Ltd
- K181137, IT-III active System manufactured by Neobiotech Co., Ltd.
Indications for Use:
Dentis i-Clean 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. 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
4
Device Description:
Dentis i-Clean system is intended for use as an aid in prosthetic restoration. It consists of Abutments and Abutment screws.
| Dentis i-Clean Abutments are compatible with the fixtures below: |
|---|
| No. | Device Name | Dimension Ranges | |||
|---|---|---|---|---|---|
| 1 | i-Clean OneQ-SL Fixture | ||||
| (K142313) | Platform | ||||
| Diameter | Implant Nominal | ||||
| Diameter | Implant Apical | ||||
| Diameter | Length Available | ||||
| Ø6.5 | Ø4.7 | Ø4.2 | 7, 8, 10, 12, 14 | ||
| Ø5.2 | Ø4.7 | 7, 8, 10, 12, 14 | |||
| Ø6.0 | Ø4.8 | 7, 8, 10, 12 | |||
| Ø7.0 | Ø5.75 | 7, 8, 10, 12 |
Tolerance of dimension shall be within ± 1% range.
The dimensions of abutments are as following:
| No. | Device Name | Dimension Ranges | Angulation |
|---|---|---|---|
| 1 | i-Clean Angled Abutment | Ø3.7 and 4.3 (D) x 9.4 and 9.6mm (L) | 15° and 25° |
| 2 | i-Clean Temporary Abutment | Ø6.9 (D) x 12.85, 13.85, 14.85 and 15.85mm (L) | 0° |
| 3 | i-Clean CCM UCLA Abutment | Ø5.1, 6.3 and 6.8 (D) x 14.95 and 15.05mm (L) | 0° |
| 4 | i-Clean Octa CCM Cylinder | Ø5.0, 6.3 and 6.8 (D) x 12.45 and 12.65mm (L) | 0° |
| 5 | i-Clean Abutment Screw | Ø1.96 (D) x 7.7mm (L) | 0° |
| 6 | Octa Abutment Connector Screw | Ø1.96 (D) x 4.7mm (L) | 0° |
| 7 | i-Clean Cylinder Screw | Ø2.5 (D) x 4.5mm (L) | 0° |
i-Clean Octa CCM cylinder is intended to be used with the straight i-Clean Octa Abutment cleared in K171027.
The Abutments have below featured:
| Name | Uses | Surface | Connection |
|---|---|---|---|
| i-Clean Angled Abutment | The Abutment is connected with fixture and it | ||
| supports prosthesis which restores tooth function. | Non | ||
| i-Clean Temporary Abutment | The Abutment is used for fabricating a temporary | ||
| provisional restoration. | Non | ||
| i-Clean CCM UCLA Abutment | The Abutment is connected with fixture and it | ||
| supports prosthesis which restores tooth function. | Non | Octa | |
| i-Clean Octa CCM Cylinder | The Abutment is connected with straight i-Clean | ||
| Octa Abutment (cleared in K171027) to support | |||
| prosthesis which restores tooth function. | Non | ||
| i-Clean Abutment Screw | This screw is used for connecting the fixture and | ||
| abutment | Non | ||
| Octa Abutment Connector Screw | This screw is used for connecting the fixture and | ||
| abutment | Non | Screw | |
| i-Clean Cylinder Screw | This screw is used for connecting the fixture and | ||
| abutment | Non | retained |
Tolerance of dimensions for Abutments shall be within ± 1% range.
Abutments are provided non-sterilized and must be steam sterilized by the end user before placement.
Materials:
- i-Clean Angled Abutment, i-Clean Abutment screw, Octa Abutment Connector Screw, and i-Clean ● Cylinder screw are fabricated from Ti-6A1-4V of ASTM F136
- i-Clean Temporary Abutment is fabricated from Polyetheretherketone (PEEK) ASTM F2026 ●
- i-Clean CCM UCLA Abutment and i-Clean Octa CCM Cylinder is fabricated from Chrome-● cobalt-molybdenum (CCM) alloy material ISO5832 and Acetal (POM)
5
| Subject Device | Primary Predicate | |
|---|---|---|
| K number | K230307 | K210134 |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd |
| Trade Name | Dentis i-Clean System | Dentis s-Clean s-Line |
| Indications for | ||
| Use | Dentis i-Clean 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. This system is intended for | ||
| delayed loading. | Dentis s-Clean s-Line 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. | ||
| Comparison | The subject device and primary predicate, K210134 have same indication for use. There is no | |
| difference, therefore, both devices are substantially equivalent. |
Summaries of Technological Characteristics & Substantial Equivalence Discussion
i-Clean Angled Abutment
| Subject Device | Reference Device | |
|---|---|---|
| K number | K230307 | K181137 |
| Manufacturer | Dentis Co., Ltd | Neobiotech Co., Ltd |
| Trade Name | Dentis i-Clean System | IT-III active System |
| Product Name | i-Clean Angled Abutment | IT Pre Angled Abutment |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Diameter | Ø3.7 and 4.3 | Ø3.7 and 4.3 |
| Length | 9.4, 9.55 and 9.6mm | 9.5 and 9.68 |
| Angle | 15° and 25° | 15° and 25° |
| Coating | Non | Non |
| Material | Ti-6AL-4V ELI (ASTM F136) | Ti-6AL-4V ELI (ASTM F136) |
| Sterilization | End-User Sterile | End-User Sterile |
| Comparison | The subject device and reference Device (K181137) have same indication for use, diameter, | |
| angulation, coating, material, and sterilization method. The length between two devices are | ||
| different, however, it does not affect the device performance, therefore, subject device and | ||
| predicate device are substantially equivalent. |
6
i-Clean Temporary Abutment
| Subject Device | Reference Device | |
|---|---|---|
| K number | K230307 | K171027 |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd |
| Trade Name | Dentis i-Clean System | Dentis Dental Implant System |
| Product Name | i-Clean Temporary Abutment | s-Clean Temporary Abutment |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Diameter | Ø6.9 | Ø4.5, 4.8, 5.5, 6.0 and 6.5 |
| Length | 12.85, 13.85, 14.85 and 15.85mm | 13.4 and 13.54 |
| Material | PEEK | PEEK |
| Angulation | 0° | 0° |
| Sterilization | End-user Sterile | End-user Sterile |
| Comparison | The subject device and reference device (K171027) have same indication for use, material, and | |
| sterilization method. The diameter and length are different, but this difference is not important | ||
| factor to the device performance because they are used temporarily. Therefore, subject device | ||
| and predicate device are substantially equivalent. |
i-Clean CCM UCLA Abutment
| Subject Device | Reference Device | ||
|---|---|---|---|
| K number | K230307 | K173120 | |
| Manufacturer | Dentis Co., Ltd | InnoBioSurg. Co., Ltd | |
| Trade Name | Dentis i-Clean System | CCM Abutment System | |
| Product Name | i-Clean CCM UCLA Abutment | UCLA Abutment | |
| Design | Image: i-Clean CCM UCLA Abutment | Image: UCLA Abutment | |
| Diameter | $Ø$ 5.1, 6.3 and 6.8 | $Ø$ 4.0, 4.5, 5.0, 5.5 and 6.0 | |
| Length | 14.95 and 15.05 | 14, 15,16 and 17mm | |
| Material | Body:CCM, Sleeve:POM | Body:CCM, Sleeve:POM | |
| Angulation | 0° | 0° | |
| Minimum Post | |||
| Heights after end | |||
| user modification | 4mm | 4mm | |
| Sterilization | End-user Sterile | End-user Sterile | |
| Comparison | The subject device and reference device, K173120 have same indication for use, material, and | ||
| sterilization method. The dimensions between two devices are different but this difference is not | |||
| important factor to the device performance because sleeve part is cutting by end-user. Therefore, | |||
| subject device and predicate device are substantially equivalent. |
7
i-Clean Octa CCM Cylinder
| Subject Device | Reference Device | |
|---|---|---|
| K number | K230307 | K173120 |
| Manufacturer | Dentis Co., Ltd | InnoBioSurg. Co., Ltd |
| Trade Name | Dentis i-Clean System | CCM Abutment System |
| Product Name | i-Clean Octa CCM Cylinder | UCLA Abutment |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Diameter | Ø5.0, 6.3 and 6.8 | Ø4.0, 4.5, 5.0, 5.5 and 6.0 |
| Length | 12.45 and 12.65 | 14, 15,16 and 17mm |
| Material | Body:CCM, Sleeve:POM | Body:CCM, Sleeve:POM |
| Angulation | 0° | 0° |
| Sterilization | End-user Sterile | End-user Sterile |
| Comparison | The subject device and reference device, K173120 have same indication for use, material, and | |
| sterilization method. The dimensions between two devices are different but this difference is not | ||
| important factor to the device performance because sleeve part is cutting by end-user. | ||
| Therefore, subject device and predicate device are substantially equivalent. |
Octa Abutment Connector Screw
| Subject Device | Reference Device | |
|---|---|---|
| K number | K230307 | K210134 |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd |
| Trade Name | Dentis i-Clean System | Dentis s-Clean s-Line |
| Model Name | Octa Abutment Connector Screw | s-Clean Abutment Screw s-Line |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Head Diameter | Ø2.5 | Ø2.32 |
| Length | 4.7mm | 9.4mm |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Sterilization | End-user Sterile | End-user Sterile |
| Comparison | The subject device and reference device (K210134) have same indication for use, material, and | |
| sterilization method. The diameter and length are different, but this difference is not important | ||
| factor to the device performance. Therefore, subject device and predicate device are substantially | ||
| equivalent. |
i-Clean Abutment Screw
| Subject Device | Reference Device | |
|---|---|---|
| K number | NA | K210134 |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd |
| Trade Name | Dentis i-Clean System | Dentis s-Clean s-Line |
| Model Name | Octa Abutment Connector Screw | s-Clean Abutment Screw s-Line |
| Design | Image: Subject Device Screw | Image: Reference Device Screw |
| Head Diameter | Ø2.5 | Ø2.32 |
| Length | 7.7mm | 9.4mm |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Sterilization | End-user Sterile | End-user Sterile |
| Comparison | The subject device and reference device (K210134) have same indication for use, material, and | |
| sterilization method. The diameter and length are different, but this difference is not important | ||
| factor to the device performance. Therefore, subject device and predicate device are | ||
| substantially equivalent. |
8
| i-Clean Cylinder Screw | |
|---|---|
| Subject Device | Reference Device | |
|---|---|---|
| K number | NA | K210134 |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd |
| Trade Name | Dentis i-Clean System | Dentis s-Clean s-Line |
| Model Name | i-Clean Cylinder Screw | s-Clean Abutment Screw s-Line |
| Design | Image: Screw | Image: Screw |
| Head Diameter | Ø2.5 | Ø2.32 |
| Length | 4.5mm | 9.4mm |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Sterilization | End-user Sterile | End-user Sterile |
| Comparison | The subject device and reference device (K210134) have same indication for use, material, and | |
| sterilization method. The diameter and length are different, but this difference is not important | ||
| factor to the device performance. Therefore, subject device and predicate device are | ||
| substantially equivalent. |
Non-Clinical Test Data
Below tests were performed on subject device:
- Fatigue Testing under the worst-case scenario according to ISO 14801:2016 ●
- . End user Sterilization Validation for Abutment made of PEEK and CCM materials according to ISO 17665-1,-2, and ISO 11737-1.
Below tests were performed for predicate devices and leveraged for the subject device:
- . End User Sterilization Validation for Abutments made of Ti-6AI-4V ELI according to ISO 17665-1,-2, and ISO 11737-1 referenced in K111364
- Biocompatibility testing on Abutments made of Ti-6Al-4V ELI according to ISO 10993-1:2009 referenced in K171027 and K150344
- . Biocompatibility testing on Abutments made of PEEK and CCM according to ISO 10993-1:2009 referenced in K171027
The Fatigue Testing was performed under the worst-case scenario according to ISO 14801:2016.
For all subject devices delivered non-sterile to be end-user sterilized, the recommended sterilization has been validated according to ISO 17665-1 and ISO 17665-2 and to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015". The worst-case construct was tested.
The Biocompatibility test was conducted on the predicate device and leveraged for the subject device because both products are manufactured with the same materials and manufacturing process. It demonstrates that the subject device is substantially equivalent with the predicate.
MR Environment Condition
Non-clinical worst-case MRI review was performed to evaluate the metallic devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal
9
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 bodies, 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.
Clinical testing was not necessary to establish substantial equivalency of the device.
Conclusion
Dentis i-Clean System 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 predicate device. Therefore, Dentis i-Clean System and its predicate are substantially equivalent.