(158 days)
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 i-Clean system is intended for use as an aid in prosthetic restoration. It consists of Abutments and Abutment screws.
The Dentis i-Clean System is a dental implant system consisting of abutments and abutment screws. The device is not an AI/ML device, and therefore the standard acceptance criteria for such devices, along with the study design elements listed, do not apply.
Here's an overview of the non-clinical testing performed to demonstrate substantial equivalence, as described in the provided document:
1. A table of acceptance criteria and the reported device performance
Since this is not an AI/ML device, there are no performance metrics like sensitivity, specificity, or AUC with acceptance criteria described in the document. The substantial equivalence is based on meeting engineering and biological safety standards for medical devices.
The non-clinical tests performed and their respective standards are:
| Acceptance Criteria (Test) | Reference Standard | Reported Device Performance (Compliance) |
|---|---|---|
| Fatigue Testing | ISO 14801:2016 | Performed under worst-case scenario. |
| End-user Sterilization Validation (PEEK, CCM) | ISO 17665-1, -2, ISO 11737-1, FDA guidance "Reprocessing Medical Devices..." (March 17, 2015) | Validated the recommended sterilization for all subject devices delivered non-sterile to be end-user sterilized. |
| End-user Sterilization Validation (Ti-6Al-4V ELI) | ISO 17665-1, -2, ISO 11737-1 (leveraged from K111364) | Leveraged from predicate device, demonstrating substantial equivalence. |
| Biocompatibility (Ti-6Al-4V ELI) | ISO 10993-1:2009 (leveraged from K171027 and K150344) | Leveraged from predicate device, demonstrating substantial equivalence. |
| Biocompatibility (PEEK, CCM) | ISO 10993-1:2009 (leveraged from K171027) | Leveraged from predicate device, demonstrating substantial equivalence. |
| MRI Safety Review | FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" | Non-clinical worst-case MRI review performed using scientific rationale and published literature. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of AI/ML. The tests mentioned are non-clinical (mechanical, sterilization, biocompatibility, MRI review). The sample sizes for these engineering and biological tests are not detailed in this summary but are typically defined by the respective ISO standards. The data provenance is presumed to be from laboratory testing performed by, or on behalf of, Dentis Co., Ltd. (Korea, as per submitter address) or the referenced predicate device manufacturers. These are not human data, so "retrospective or prospective" does not apply.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as this is not an AI/ML device involving human experts for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not an AI/ML device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of AI/ML. For medical devices, "ground truth" is typically defined by adherence to established engineering standards (e.g., ISO 14801 for fatigue) and biological safety standards (e.g., ISO 10993 for biocompatibility, ISO 17665 for sterilization).
8. The sample size for the training set
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.
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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.
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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
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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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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
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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) | PlatformDiameter | Implant NominalDiameter | Implant ApicalDiameter | 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 itsupports prosthesis which restores tooth function. | Non | |
| i-Clean Temporary Abutment | The Abutment is used for fabricating a temporaryprovisional restoration. | Non | |
| i-Clean CCM UCLA Abutment | The Abutment is connected with fixture and itsupports prosthesis which restores tooth function. | Non | Octa |
| i-Clean Octa CCM Cylinder | The Abutment is connected with straight i-CleanOcta Abutment (cleared in K171027) to supportprosthesis which restores tooth function. | Non | |
| i-Clean Abutment Screw | This screw is used for connecting the fixture andabutment | Non | |
| Octa Abutment Connector Screw | This screw is used for connecting the fixture andabutment | Non | Screw |
| i-Clean Cylinder Screw | This screw is used for connecting the fixture andabutment | 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)
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| 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 forUse | Dentis i-Clean System is indicated for use inpartially or fully edentulous mandibles andmaxillae, in support of single or multiple unitrestorations including; cemented retained,screw retained, or overdenture restorations,and terminal or intermediate abutmentsupport for fixed bridgework. This system isdedicated for one and two stage surgicalprocedures. This system is intended fordelayed loading. | Dentis s-Clean s-Line is indicated for use inpartially or fully edentulous mandibles andmaxillae, in support of single or multiple unitrestorations including; cemented retained,screw retained, or overdenture restorations,and terminal or intermediate abutment supportfor fixed bridgework. This system is dedicatedfor 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 nodifference, 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 aredifferent, however, it does not affect the device performance, therefore, subject device andpredicate device are substantially equivalent. |
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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, andsterilization method. The diameter and length are different, but this difference is not importantfactor to the device performance because they are used temporarily. Therefore, subject deviceand 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 PostHeights after enduser modification | 4mm | 4mm | |
| Sterilization | End-user Sterile | End-user Sterile | |
| Comparison | The subject device and reference device, K173120 have same indication for use, material, andsterilization method. The dimensions between two devices are different but this difference is notimportant factor to the device performance because sleeve part is cutting by end-user. Therefore,subject device and predicate device are substantially equivalent. |
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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, andsterilization method. The dimensions between two devices are different but this difference is notimportant 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, andsterilization method. The diameter and length are different, but this difference is not importantfactor to the device performance. Therefore, subject device and predicate device are substantiallyequivalent. |
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, andsterilization method. The diameter and length are different, but this difference is not importantfactor to the device performance. Therefore, subject device and predicate device aresubstantially equivalent. |
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| 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, andsterilization method. The diameter and length are different, but this difference is not importantfactor to the device performance. Therefore, subject device and predicate device aresubstantially 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
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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.
§ 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.)