Ni2 Implant System
Device Facts
| Record ID | K221847 |
|---|---|
| Device Name | Ni2 Implant System |
| Applicant | Newton Implant Systems, Inc. |
| Product Code | DZE · Dental |
| Decision Date | Apr 11, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Ni2 Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The smaller Ni2 dental implants (Ø3.6, 4.0, 5.0 mm) can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability is achieved with appropriate occlusal loading. The larger Ni2 Implants (Ø6.0, 7.0 mm) can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.
Device Story
Ni2 Implant System consists of endosseous dental implants, superstructures, and surgical/prosthetic instruments. Implants are screw-type, fabricated from Grade 4 CP titanium (ASTM F67) with S.L.A. (sand-blasted, large-grit, acid-etched) surface treatment. Used by dental surgeons in clinical settings for partially or fully edentulous patients. Implants are surgically inserted into the jawbone to serve as artificial tooth roots. Abutments connect to implants via a tapered conical hex joint to support crowns, bridges, or overdentures. System supports both one-stage and two-stage surgical protocols. Output is a stable foundation for prosthetic restoration, enabling chewing function recovery. Device is supplied sterile via gamma radiation.
Clinical Evidence
No clinical studies are submitted. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility (ISO 10993-1), sterilization validation (ISO 11137), and MRI safety assessment.
Technological Characteristics
Material: CP Titanium Grade 4 (ASTM F67). Surface: S.L.A. (Sand-blasted, large-grit, acid-etched). Connection: Tapered conical hex. Sterilization: Gamma radiation. Shelf life: 8 years. Form factor: Screw-type endosseous implant.
Indications for Use
Indicated for patients requiring single or multiple unit prosthetic restoration in the upper or lower jaw arches. Smaller implants (Ø3.6-5.0mm) suitable for immediate or delayed loading; larger implants (Ø6.0-7.0mm) indicated for molar region with delayed loading.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- S-Plant Dental Implant System (K221866)
Reference Devices
- DIO UF HSA Internal Sub-merged Implant System (K122519)
- Noris Medical Dental Implant System -Cortical (K210852)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Newton Implant Systems, Inc % Joyce Kwon CEO Provision Consulting Group, Inc. 13925 City Center Street, Suite 200 Chino Hills, California 91709
April 11, 2024
Re: K221847
Trade/Device Name: Ni2 Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: March 11, 2024 Received: March 12, 2024
Dear Joyce Kwon:
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.
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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" (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 QS 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.
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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 I. Steen -S
Andrew I. 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) K221847
Device Name Ni2 Impant System
#### Indications for Use (Describe)
The Ni2 Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The smaller Ni2 dental implants (Ø3.6, 4.0, 5.0 mm) can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability is achieved with appropriate occlusal loading. The larger Ni2 Implants (06.0, 7.0 mm) can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| <span></span> | <span></span> |
| <div></div> | <div></div> |
| | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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# 510(k) Summary
#### 510(k) Submitter
Pedro Yang Newton Implant Systems, Inc. 6272 Flanders Dr. #220 San Diego, CA 92121
#### Official Correspondent / Contact Person
Joyce Kwon, CEO/Principal Consultant Provision Consulting Group, Inc. 13925 City Center Dr. Suite 200 Chino Hills, CA 91709 +1-909-493-3276 joyce(@provisionfda.com
#### Date Prepared
4/10/2024
#### Device Information
- Trade Name: Ni2 Implant System
- Common Name: Endosseous Dental Implant ●
- Classification Name: Implant, Dental, Endosseous, Root-Form ●
- Regulation Number: 21 CFR 872.3640
- Device Class: Class II ●
- . Product Code: DZE
#### Predicate Devices
Fixture:
- . S-Plant Dental Implant System (K221866)
#### Reference Device
- DIO UF HSA Internal Sub-merged Implant System (K122519) ●
- Noris Medical Dental Implant System -Cortical (K210852) ●
#### Indication for Use
The Ni2 Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The smaller Ni2 dental implants (03.6, 4.0, 5.0 mm) can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability is achieved with
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appropriate occlusal loading. The larger Ni2 Implants (Ø6.0, 7.0 mm) can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delaved loading.
## Device Description
The Ni2 Implant System is comprised of dental implants, superstructures, instruments for prosthetics and surgical instruments. The Ni2 Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm implant when surgically implanted under controlled conditions. They are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations.
The Ni2 Implant System, fixtures are made of commercial pure titanium, grade 4 (ASTM F67) which have a S.L.A (Sand blasted large grit acid etched) treated surface and supplied sterile (gamma radiation). These fixtures can be used one stage surgery method or two stage surgery method. And that are surgically inserted into the upper and/or lower jawbone. The fixtures replace tooth root as providing a stable foundation for restorations.
Geometrically, the implant is screw type. An abutment is connected to the implant through a tapered joint. The Ni2 fixtures are compatible with the abutments which have been previously cleared in K221866.
The non-threaded section of the implant body is also SLA surface treated.
#### Substantial Equivalent Comparison Chart
Image /page/5/Figure/8 description: The image shows a diagram of a screw with three dimensions labeled. The total length of the screw is labeled as L1. The length of the screw threads is labeled as L2, and the length of the unthreaded part of the screw is labeled as L3.
L1: Endosseous Implant Length L2: Threaded SLA treated length L3: Non-threaded SLA treated length
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| | Subject | Primary Predicate | Reference device | Reference device | |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Device Name | Ni2 Implant System | S-Plant Dental Implant System | DIO UF HSA Internal | Noris Medical Dental Implants | |
| | | | Sub-merged Implant System | System -Cortical | |
| Regulation # | 21 CFR 872.3640 | 21 CFR 872.3640 | 21 CFR 872.3640 | 21 CFR 872.3640 | |
| Regulation Name | Endosseous Dental Implant | Endosseous Dental Implant | Endosseous Dental Implant | Endosseous Dental Implant | |
| Classification | Class 2 | Class 2 | Class 2 | Class 2 | |
| 510(k) # | K221847 | K221866 | K122519 | K210852 | |
| Product Code | DZE | DZE | DZE | DZE | |
| Manufacturer | IDIS Co., Ltd. | IDIS Co., Ltd. | DIO Corporation | Noris Medical Ltd | |
| | Intended Use | Functional and esthetic | Functional and esthetic | Functional and esthetic | Functional and esthetic |
| | | rehabilitation of the | rehabilitation of the | rehabilitation of the | rehabilitation of the |
| | | edentulous mandible or | edentulous mandible or | edentulous mandible or | edentulous mandible or |
| | | maxilla | maxilla | maxilla | maxilla |
| Indications for Use | The Ni2 Implant System is<br>indicated for surgical<br>placement in the upper and<br>lower jaw arches, to provide a<br>root form means for single or<br>multiple units' prosthetic<br>attachment to restore a<br>patient's chewing function.<br>The smaller Ni2 dental<br>implants (Ø3.6, 4.0, 5.0 mm)<br>can be placed with a<br>conventional two stage<br>surgical process with an option<br>for transmucosal healing or<br>they can be placed in a single<br>stage surgical process for<br>immediate loading when good<br>primary stability is achieved<br>with appropriate occlusal<br>loading. The larger Ni2<br>Implants (Ø6.0, 7.0 mm) can<br>be placed with a conventional<br>two stage surgical process with<br>an option for transmucosal<br>healing and are indicated for<br>the molar region with delayed<br>loading. | The S-Plant Dental Implant<br>System is indicated for<br>surgical placement in the<br>upper and lower jaw arches, to<br>provide a root form means for<br>single or multiple units'<br>prosthetic attachment to<br>restore a patient's chewing<br>function. The smaller S-Plant<br>Dental Implants (Ø3.4, 3.6,<br>3.8, 4.2, 4.7, 5.2 mm) can be<br>placed with a conventional two<br>stage surgical process with an<br>option for transmucosal<br>healing or they can be placed<br>in a single stage surgical<br>process for immediate loading<br>when good primary stability is<br>achieved with appropriate<br>occlusal loading. The larger S-<br>Plant Dental Implants (Ø6.0,<br>7.0 mm) can be placed with a<br>conventional two stage<br>surgical process with an option<br>for transmucosal healing and<br>are indicated for the molar<br>region with delayed loading. | The DIO UF I-ISA Internal<br>Sub-Merged Implant System is<br>indicated for surgical<br>placement in the upper and<br>lower Jaw arches, to provide a<br>root form means for single or<br>multiple units' prosthetic<br>attachment to restore a<br>patient's chewing Function.<br>The smaller (Ø3.8 ~ Ø5.5)<br>implants can be placed with a<br>conventional two stage<br>surgical process with an option<br>for transmucosal healing or<br>they can be placed in a single<br>stage surgical process for<br>immediate loading when good<br>primary stability is achieved<br>with appropriate occlusal<br>loading. The larger (Ø6.0 ~<br>Ø7.0) implants can be placed<br>with a conventional two stage<br>surgical process with an option<br>for transmucosal healing and<br>are indicated for the molar<br>region with delayed loading. | Noris Medical Dental Implants<br>System is intended to replace<br>missing tooth/teeth in either<br>jaw for supporting prosthetic<br>devices that may aid in<br>restoring the patient's chewing<br>function. The procedure can be<br>accomplished in a one--stage<br>or two-stage surgical<br>operation. All implants are<br>appropriate for immediate<br>loading when good primary<br>stability is achieved and with<br>appropriate occlusal loading. | |
| | | | | | |
| | Dual abutments are intended<br>for use with a dental implant to<br>provide support for prosthetic<br>restorations such as crowns,<br>bridges, or overdentures.<br>Healing abutments are used to<br>make a natural soft tissue<br>shape before setting up<br>prosthetics and removing<br>cover screw after<br>osseointegration. Cover<br>Screws are used to protect the<br>internal portion of the implant,<br>preventing soft tissue growth<br>into the implant, facilitating<br>provisional restorations when<br>necessary, and enabling the<br>transition to final restoration<br>components once<br>osseointegration is complete. | | | | |
| Prosthetic Interface<br>Connection | Tapered conical hex | Tapered conical hex | Tapered conical hex | Internal Hex | |
| | Image: Tapered conical hex | Image: Tapered conical hex | Image: Tapered conical hex | Image: Internal Hex | |
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| Fixture Diameter and<br>Endosseous Length<br>(mm) | Diameter<br>L1 (mm)<br>(mm) | Diameter<br>Endosseous<br>Length (mm)<br>(mm) | Diameter<br>Endosseous<br>(mm)<br>Length (mm) | Diameter<br>Endosseous<br>(mm)<br>Length (mm) |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Ø3.6<br>8.5, 10.0, 11.5,<br>13.0, 15.0<br>Ø4.0<br>7.0, 8.5, 10.0,<br>11.5, 13.0, 15.0<br>Ø5.0<br>7.0, 8.5, 10.0,<br>11.5, 13.0, 15.0<br>Ø6.0<br>7.0, 8.5, 10.0,<br>11.5<br>Ø7.0<br>7.0, 8.5 | Ø3.4<br>8.5, 10.0, 11.5,<br>13.0, 15.0<br>Ø3.6<br>8.5, 10.0, 11.5,<br>13.0, 15.0<br>Ø3.8<br>7.0, 8.5, 10.0,<br>11.5, 13.0,<br>15.0<br>Ø4.2<br>7.0, 8.5, 10.0,<br>11.5, 13.0<br>Ø4.7<br>7.0, 8.5, 10.0,<br>11.5, 13.0<br>Ø5.2<br>7.0, 8.5, 10.0,<br>11.5<br>Ø6.0<br>7.0, 8.5, 10.0,<br>11.5<br>Ø7.0<br>7.0, 8.5 | Ø3.8<br>7.0, 8.5, 10,<br>11.5, 13.0,<br>15.0, 16.0<br>Ø4.0<br>7.0, 8.5, 10,<br>11.5, 13.0,<br>15.0, 16.0<br>Ø4.5<br>7.0, 8.5, 10,<br>11.5, 13.0,<br>15.0, 16.0<br>Ø5.0<br>7.0, 8.5, 10,<br>11.5, 13.0,<br>15.0, 16.0<br>Ø5.5<br>7.0, 8.5, 10,<br>11.5, 13.0,<br>15.0, 16.0<br>Ø6.0<br>7.0, 8.5<br>Ø7.0<br>7.0, 8.5 | Ø4.0<br>7.5, 9, 12, 14,<br>16<br>Ø5.0<br>7.5, 9, 12<br>Ø6.0<br>7.5, 9, 12 |
| Non-Threaded Length<br>(mm) | 2.0 mm for all lengths.<br>Length within the<br>bone(and surface<br>treated for<br>osseointegration). | N/A | N/A | For L7.5: 0.7<br>For L9: 1.0<br>For L12: 2.0<br>For L14: 3.0<br>For L16: 3.5<br>Length within the<br>bone(and surface<br>treated for<br>osseointegration) |
| Fixture Diameter and<br>Threaded Length<br>(mm) | Diameter<br>L2 (mm)<br>(mm)<br>Ø3.6<br>6.5, 8.0, 9.5,<br>11.0, 13.0<br>Ø4.0<br>5.0, 6.5, 8.0,<br>9.5, 11.0, 13.0<br>Ø5.0<br>5.0, 6.5, 8.0,<br>9.5, 11.0, 13.0<br>Ø6.0<br>5.0, 6.5, 8.0,<br>9.5, 11.0, 13.0 | Diameter<br>Endosseous<br>Length (mm)<br>(mm)<br>Ø3.4<br>8.5, 10.0, 11.5,<br>13.0, 15.0<br>Ø3.6<br>8.5, 10.0, 11.5,<br>13.0, 15.0<br>Ø3.8<br>7.0, 8.5, 10.0,<br>11.5, 13.0,<br>15.0 | Diameter<br>Endosseous<br>Length (mm)<br>(mm)<br>Ø3.8<br>7.0, 8.5, 10,<br>11.5, 13.0,<br>15.0, 16.0<br>Ø4.0<br>7.0, 8.5, 10,<br>11.5, 13.0,<br>15.0, 16.0 | Diameter<br>Endosseous<br>(mm)<br>Length (mm)<br>Ø4.0<br>6.8, 8.0, 10.0,<br>11.0, 12.5<br>Ø5.0<br>6.8, 8.0, 10.0<br>Ø6.0<br>6.8, 8.0, 10.0 |
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# K221847
| | Ø7.0 | Ø4.2 | Ø4.5 | |
|-------------------------------|-----------------------------|---------------------------------------|----------------------------------------------------|------------------------------------|
| | 5.0, 6.5 | 7.0, 8.5, 10.0,<br>11.5, 13.0 | 7.0, 8.5, 10,<br>11.5, 13.0,<br>15.0, 16.0 | |
| | | Ø4.7<br>7.0, 8.5, 10.0,<br>11.5, 13.0 | Ø5.0<br>7.0, 8.5, 10,<br>11.5, 13.0,<br>15.0, 16.0 | |
| | | Ø5.2<br>7.0, 8.5, 10.0,<br>11.5 | Ø5.5<br>7.0, 8.5, 10,<br>11.5, 13.0,<br>15.0, 16.0 | |
| | | Ø6.0<br>7.0, 8.5, 10.0,<br>11.5 | Ø6.0<br>7.0, 8.5 | |
| | | Ø7.0<br>7.0, 8.5 | Ø7.0<br>7.0, 8.5 | |
| Implant Material | CP Ti Grade 4<br>(ASTM F67) | CP Ti Grade 4<br>(ASTM F67) | CP Ti Grade 4<br>(ASTM F67) | CP Ti Grade 4<br>(ASTM F67) |
| Implant Endosseous<br>Surface | S.L.A. | S.L.A. | S.L.A. | RBM (Resorbable<br>Blasting Media) |
| Implant Placement | Bone Level | Bone Level | Bone Level | Bone Level |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
| Shelf Life | 8 years | 8 years | 5 years | 5 years |
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# Substantial Equivalence Discussion
- 1. General Indications: Both the subject device and the predicate device share similar overarching indications for use. They are both designed for surgical placement in the upper and lower jaw arches, with the primary goal of providing a root form means for prosthetic attachment to restore a patient's chewing function.
- 2. Implant Sizes and Surgical Procedures: Both systems offer a range of implant sizes to accommodate various clinical scenarios. The smaller implants of both systems (03.6~ 05.2 mm) can be placed using a conventional two stage surgical process, with the option for transmucosal healing. Additionally, both systems provide the flexibility of a single-stage surgical process for immediate loading when there is good primary stability, with appropriate occlusal loading. The non-threaded section of the implant body is also SLA surface treated.
- 3. Molar Region and Delayed Loading: The larger implants in both systems (Ø6.0 ~ Ø7.0 mm) are specifically indicated for the molar region and involve a conventional two-stage surgical process with an option for transmucosal healing, accompanied by delayed loading. This demonstrates a parallel approach to addressing the unique requirements of the molar region.
Discussion: The comparisons highlight the substantial equivalence between the subject and the predicate device. The similarities in their indications for use, design, implant sizes, and surgical procedures demonstrate that the differences do not impact substantial equivalence.
The minor variations in implant dimensions and specific procedural details are well within the acceptable range for dental implant systems, considering the diverse clinical needs and preferences of practitioners. Both systems provide suitable options for immediate loading and delayed loading based on clinical conditions, indicating flexibility in accommodating various patient cases.
The Ni2 Implant System is similar to the predicate device (K221866) in terms of its design, dimensions, material, surface treatment, intended use, and technological characteristics. The subject device also includes diameters (3.6, 4.0, 5.0mm) that are not covered by the predicate device, but they fall within the range between the diameter of the reference devices (K122519 and K210852) and the diameter of the predicate device. Specifically, K210852 was included as a reference device to support the design of the 2mm of unthreaded SLA surface treated bone level implant body length implanted into the bone as the 2mm of unthreaded SLA surface treated of the subject device falls into the range of the reference device, K210852, which is between 0.7mm ~ 3.5mm.
# Non-Clinical Test Data
The non-clinical test data submitted for the Ni2 implant system validates its substantial equivalence to the predicate device. The outcomes collectively support the substantial equivalence of the Ni2 Implant System to the predicate device.
- . The subject device will not be labeled as "non-pyrogenic". Bacterial Endotoxin Testing (LAL) in accordance with USP<85> and USP<161> in K221866.
- . Requirements for biological evaluation of the subject device were based on the ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Biocompatibility testing information is leveraged from predicate device, K221866. The Biocompatibility Test was conducted on the K221866 predicate device is leveraged for the subject device because both products are manufactured with similar materials, manufacturer, manufacturing process.
- . Referenced from our own predicate K221866, is sterile barrier shelf-life data according to
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ASTM F1980 and sterilization on Implants according to ISO 11137-1,2,3 referenced in K221866. Validation of the gamma irra…
