DSI Dental Implant System

K200188 · Dsi Dental Solutions, Ltd. · DZE · Apr 1, 2020 · Dental

Device Facts

• Record ID: K200188
• Device Name: DSI Dental Implant System
• Applicant: Dsi Dental Solutions, Ltd.
• Product Code: DZE · Dental
• Decision Date: Apr 1, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DSI Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients and chewing function. DSI implants are intended for single or multiple unit restorations on splinted applications. Premium Spiral implants are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period.

Device Story

DSI Dental Implant System consists of internal hex, slightly tapered spiral titanium alloy (ASTM F136) implants with micro-rings at the neck; grit-blasted and acid-etched surface. System includes various screw-retained permanent abutments (straight, anatomic angled, shoulder, multi-unit, ball attachments, overdenture) and temporary healing caps. Used by dental professionals in clinical settings for surgical placement in jaw bone to support prosthetic restorations. Implants provide mechanical foundation for artificial teeth; abutments connect implants to prosthetics. Immediate loading possible with Premium Spiral implants if primary stability is achieved. Benefits include restoration of chewing function and esthetics. Device output is a stable, osseointegrated base for dental prostheses.

Clinical Evidence

Bench testing only. Dynamic fatigue testing per ISO 14801 demonstrated run-out limits comparable or superior to predicate systems. Surface analysis confirmed surface treatment does not adversely affect cytotoxicity. Sterilization validated per ISO 11137 (implants) and ISO 17665 (abutments). Package integrity, accelerated aging, and endotoxin testing (USP 161) performed.

Technological Characteristics

Material: ASTM F136 Ti 6Al 4V ELI titanium alloy. Design: Internal hex connection, tapered spiral implant body with micro-rings. Surface: Grit-blasted and acid-etched. Sterilization: Gamma irradiation (implants), steam sterilization (abutments). Connectivity: Mechanical interface for prosthetic abutments. No software or electronic components.

Indications for Use

Indicated for patients requiring endosseous dental implants in upper or lower jaw arches to support prosthetic devices (artificial teeth) for restoration of esthetics and chewing function. Suitable for single or multiple unit restorations on splinted or non-splinted applications. Premium Spiral implants indicated for immediate loading given good primary stability and appropriate occlusive loading, or for loading after conventional healing.

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

• SpiralTech Dental Implant System Esi Hex (K170372)

Reference Devices

• Cortex (K090709)
• Ditron MPI (K140728)

Submission Summary (Full Text)

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April 1, 2020

DSI Dental Solutions Ltd % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172

Re: K200188

Trade/Device Name: DSI Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: January 20, 2020 Received: January 24, 2020

Dear Angela Blackwell:

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 (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for

Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

K200188

Device Name DSI Dental Implant System

Indications for Use (Describe)

DSI Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients and chewing function. DSI implants are intended for single or multiple unit restorations on splinted applications. Premium Spiral implants are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period.

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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# 510k Summary April 1, 2020 DSI Dental Implant System

Name and address: DSI Dental Solutions Ltd 59 haAvoda St Light Industrial Zone Ashdod Israel 7706300 Contact Person: Shlomi Krasner Phone Number: [phone] Name of device: DSI Dental Implant System Classification Name: Endosseous dental implants CFR: 21 CFR 872.3640 Primary Product Code: DZE Secondary Product Code: NHA

Device Description: DSI Dental Implant System is an internal hex implant system with one model of implant at this time, Premium Spiral is a slightly tapered spiral internal hex implant with micro-rings at the implant neck which comes in 3.5, 3.75, 4.2, 5.0, and 6.0 diameter. The implants come in lengths of 8, 10, 11.5, 13 and 16. The 6.0 diameter implant does not come in lengths of 13 or 16mm.

All implants and abutments are made of ASTM F136 Ti 6Al 4V ELI. The implants have a grit blasted and acid etched surface. Loc-in abutments are anodized. All types of abutments can be used with all implants.

Straight abutments, standard narrow abutments, anatomic angled abutments, straight shoulder abutments, and straight wide shoulder abutments are all screw-retained permanent abutments for single or multiple restorations. The system also includes abutment fixation screws. Straight abutments come in 7, 9, or 11mm lengths and shouldered straight abutments come 1, 2, 3, or 4mm in gingival height. Wide straight shoulder abutments come in gingival heights of 1, 2, or 3mm. Standard narrow abutments come in lengths of 7, 9, 11 mm. Straight wide abutments come in lengths of 9 or 11 mm. 15° anatomic angulated abutments come in gingival heights of 1, 2, or 3 mm. 25° anatomic angled abutments come in gingival heights of 1, 2, or 3mm.

Straight multi-unit abutments, Loc-in abutments, overdenture abutments, and ball attachments are permanent threaded abutments which are for multi-restorations only. Loc-in abutments come in collar heights of 0.5, 1, 2, 3, 4, 5, and 6 mm. Ball attachments come in gingival heights of 0.5, 1, 2, 3, 4, 5, or 6mm. Overdenture abutments come in gingival heights of 0.5, 1.5 mm. Overdenture abutments are used with removable dentures and partial dentures. Straight multi-units come in gingival heights of 1, 2, 3 or 4 mm. Multi-unit abutments are used for fixed restorations. Straight multi-unit mounted dentures can only be removed by the dentures mounted on flat abutments, overdentures or ball attachments can be removed by the patient.

The UCLA is 4.5mm in diameter and is for making gold restorations which are taller than 4mm.

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Healing caps (3.8, 4.5, 5.5, and 6.0 mm diameter) are temporary use abutments used during the healing phase which come in different gingival heights in order to account for tissue thickness differences. The 3.8mm diameter healing caps come in gingival heights of 3, 4, 5, 6 and 7 mm. The 4.5 and 5.5 mm diameter healing caps come in gingival heights of 2, 3, 4, 5, 6 and 7mm. The 6.3 mm diameter healing cap comes in gingival heights of 2, 3, 4, and 5 mm.

Indications for Use: DSI Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients esthetics and chewing function. DSI implants are intended for single or multiple unit restorations on splinted or non-splinted applications. Premium Spiral implants are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period.

Testing Summary: Dynamic fatigue testing according to ISO 14801 was conducted to determine the abutments and implants are strong enough for their intended use. Premium Spiral implants exhibited a run out limit about the same or higher than other implant systems. Surface analysis was done to show the surface treatment does not adversely change the cytotoxicity of the materials are ones common in dental implants and abutments are made of titanium alloy which meets ASTM F136. Sterilization was conducted on the implants according to ISO 11137-1, ISO 11137-2, and ISO 11137-3. Abutment steam sterilization was done according to ISO 17665-1 and ISO 17665-2. Package integrity testing and accelerated aging were conducted. Endotoxin testing according to USP 161 was conducted.

# Primary Predicate Device: SpiralTech Dental Implant System Esi Hex K170372 Reference Predicates: Cortex K090709 Ditron MPI K140728

### Substantial Equivalence:

DSI Dental Implant System is substantially equivalent to SpiralTech Dental Implant System in indications for use, materials, design, and fatigue performance.

| Implant System<br>Comparison Table | DSI Dental Implant<br>System<br>Premium Spiral | SpiralTech Dental<br>Implant System<br>K170372<br>ESi Hex | Ditron MPI K140728 |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Diameter of Implants<br>Premium Spiral | 3.5, 3.75, 4.2, 5.0, 6.0 | ESi Hex 3.3, 3.5, 4.3, 5.0, 6.0 | 3.3, 3.5, 3.75, 4.2, 5.0, 6.0 |
| Implant Lengths | 8, 10, 11.5, 13, 16 (6.0 mm diameter not in 13 or 16 length) | 8, 10, 11, 13, 15 | 6 (4.2, 5 and 6 only), 8, 10, 11.5, 13, and 16 |
| Surface Treatment | SLA | SLA or RBM | Unknown |
| Sterilization of Implants | Provided sterile by gamma irradiation | Provided sterile by gamma irradiation | Provided sterile by gamma irradiation |
| Sterilization of abutments | Provided non-sterile with instructions for user to sterilize them | Provided non-sterile with instructions for user to sterilize them | Provided non-sterile with instructions for user to sterilize them |
| Connection | Internal Hex | Internal Hex | Internal Hex |
| Spiral Implant Design | Premium Spiral | ESi Hex | MPI |
| ISO 14801 Fatigue Test | Run out limit is the same or higher than those of other implant systems | Run out limit is comparable to other implant systems. | Run out limit is comparable to other implant systems. |
| Indications for Use | DSI Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients esthetics and chewing function. DSI implants are intended for single or multiple unit restorations on splinted or non-splinted applications. Premium Spiral implants are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period. | The Spiraltech Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing function. Spiraltech implants are intended for single or multiple unit restorations on splinted or non-splinted applications. The implants ESi Dynamic and Ultimate are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants [along with Premium and One Piece] can also be used for loading after a conventional healing period. Solo One Piece 3.0 and 3.3 implants, Ultimate (conical) 3.0 implants, and ESi (conical) 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.0 and/or 3.3 | Ditron's Dental Implants and Abutments are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. • Two stage: MPI, ULT, API and CPI models • One stage: OPI model The 3.3 and 3.0 mm diameter models for One stage OPI, Two stage MPI, Two stage and API implants are intended only for the incisors and cuspids of the maxilla and mandible. They are also indicated for denture stabilization using multiple |

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| implants adjacent to one<br>another. | implants.<br>Two stage and One<br>stage<br>implants for<br>temporary or<br>longterm<br>use: MPI, ULT, API,<br>CPI,<br>OPI are self-tapping<br>titanium<br>threaded screws<br>indicated for long<br>term intra bony<br>applications. They<br>permit<br>immediate splint<br>stability and<br>long-term fixation<br>of new or<br>existing crown,<br>bridge and<br>prosthesis and<br>protection of<br>graft sites.<br>MPI, ULT, API, CPI<br>and OPI<br>designs are<br>indicated for<br>immediate loading<br>(except for<br>MPI and API in<br>6mm length)<br>when good primary<br>stability is<br>achieved and with<br>appropriate<br>occlusal loading.<br>MPI, ULT, API, CPI<br>and OPI<br>are indicated for<br>immediate<br>loading (except for<br>MPI and API<br>in 6mm length) in<br>single tooth<br>restorations when |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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| | | | stability is achieved<br>with<br>appropriate<br>occlusal loading. |
|----------|---------|---------|-------------------------------------------------------------------|
| Material | Ti6Al4V | Ti6Al4V | Ti6Al4V |

| | DSI Dental Implant<br>System | SpiralTech Dental<br>Implant System<br>K170372 | Cortex Dental Implant<br>System K090709 |
|------------------------------------|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Cover screw | Cover screw | Cover screw | |
| Multi-Unit Abutments* | Multi-unit abutments<br>in heights of 1,2,3 and<br>4 mm<br>Used for fixed<br>restorations. | Multi-unit abutments<br>in heights of 1,2,3 and<br>4 mm<br>Used for fixed<br>restorations. | |
| Ball attachments* | Ball attachments in<br>heights of 2,3,4,5, and<br>6mm | Ball attachments in<br>heights of 1,2,3,4,5,<br>and 6mm | |
| Healing Caps 3.8<br>diameter | Healing Cap in 3,4,5,6,7<br>mm height | Healing Abutment in<br>2,3,4,5 and 6 mm<br>height | Healing abutment<br>7mm height |
| Healing Caps 4.6<br>diameter | Healing cap in 2,3,4,5,6,<br>and 7mm height | Healing Abutment in<br>2,3,4,5, and 6 mm<br>height | Healing abutment<br>7mm height |
| Healing Caps 5.5<br>diameter | Healing cap in 2,3,4,5,6<br>and 7mm height | Healing Abutment in<br>2,3,4,5,and 6mm height | Healing abutment<br>7mm height |
| Healing Caps 6.3<br>diameter | Healing Caps in 2,3,4<br>and 5 mm height | | Healing Abutments in<br>2,3, 4 and 5 mm height |
| Standard Titanium<br>Abutment | 4.5mm Standard<br>Titanium Abutment<br>with heights of 7,9, and<br>11 mm | 4.5mm Standard Flat<br>Titanium Straight<br>Abutment with height<br>of 5,7,9 and 11 mm | |
| Standard Narrow<br>Abutment | 3.8mm Standard<br>narrow abutment with<br>heights of 7,9 and 11<br>mm | 3.8mm Narrow Flat<br>Titanium Straight<br>abutment with heights<br>of 5, 7, 9, and 11mm | |
| Standard Wide<br>Abutment | 5.5mm Standard wide<br>abutment with heights<br>of 9 mm | 5.5mm Wide Flat<br>Titanium Straight<br>abutment with heights<br>of 5, 7, 9 and 11 mm | |
| | | | |
| Standard Shoulder<br>Abutment | 4.5mm Standard<br>shoulder abutment in<br>heights of 1,2,3 and<br>4mm | 4.5mm Anatomic<br>Titanium abutment in<br>heights of 1,2,3 and<br>4mm | |
| Standard Wide<br>Shoulder Abutment | 5.4mm Standard Wide<br>Shoulder Abutment<br>with heights of 1,2,3<br>mm | 5.5mm Wide Anatomic<br>Abutment with heights<br>of 1,2 ,and 3mm | |
| Standard 15°<br>Abutment | Standard 15° Abutment<br>with heights of 1,2,3<br>mm | 15° Angulated Titanium<br>Abutment with heights<br>of 1,2,3 mm | |
| Standard 25°<br>Abutment | Standard 25° Abutment<br>with heights of 1,2,3<br>mm | 25° Angulated Titanium<br>Abutment with heights<br>of 1,2, and 3mm | |
| Loc-In Abutments * | Flat abutment in<br>heights of 1,2,3,4,5,and<br>6 mm | IPI abutment in heights<br>of 1,2,3,4,5 and 6 mm | |
| Standard Overdenture<br>Abutment* | Overdenture abutment<br>in 0.5, 1.5, and 2.5 mm<br>heights<br>Used for removable<br>restorations. | | Clever click<br>attachment with<br>heights of 0,1,2,3,4,5<br>mm<br>Used for removable<br>restorations. |
| UCLA | Castable abutments in<br>diameters 4.5mm | | Castable abutments<br>4.5mm diameter |

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*These models of abutments are not for single crown use.

#### Conclusion:

DSI Dental Implant System is substantially equivalent to SpiralTech Dental Implant System. They both have similar indications for use, are of the same material, and have internal hex connections. The language regarding small diameter implants in the predicate Indications for Use is not relevant to the subject Indications, as the smallest diameter of subject implants is outside of the precifically indicated range. The reference devices do not include any specific language in their Indications related to the components being compared to the subject system.

Performance testing demonstrates substantial equivalence to the identified predicate devices. The abutments, healing caps, and angled abutments are offered in similar designs and heights. Any abutments not found in the predicate device system are found in the reference device system. The design and size differences between predicate or reference devices and the subject devices are only minor differences in geometry and size so given the use, materials and technology is the same they do not change the substantial equivalence.