DSP Implant System

K192839 · D.S.P Industrial Eireli · DZE · Feb 11, 2021 · Dental

Device Facts

• Record ID: K192839
• Device Name: DSP Implant System
• Applicant: D.S.P Industrial Eireli
• Product Code: DZE · Dental
• Decision Date: Feb 11, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DSP Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Device Story

The DSP Implant System consists of endosseous dental implants and prosthetic components (abutments, copings, screws) used to support artificial teeth. Implants are surgically placed into the jawbone; prosthetic components are attached to the implants to support definitive or provisional restorations. The system includes various lines (HE SLIM, BIOFIT, SOULFIT, PROPFIT, WAYFIT) featuring an external hex (HE) interface. Components are used by dental professionals in clinical settings. The device restores chewing function by providing a stable foundation for crowns, bridges, or overdentures. The system utilizes standard dental surgical and restorative techniques, including screw-retained or cement-retained methods. Benefits include restoration of oral function and aesthetics for edentulous or partially edentulous patients.

Clinical Evidence

No clinical data were included in this submission. Substantial equivalence is supported by non-clinical bench testing, including sterilization validation (ISO 11137-1, ISO 17665), shelf-life/package integrity testing (ASTM F1980, F1929, F88), biocompatibility (ISO 10993-5), and pyrogenicity monitoring (USP <85>). Surface analysis via SEM/EDS confirmed no residual contaminants from manufacturing.

Technological Characteristics

Implants: Commercially pure titanium (ASTM F67), grit-blasted and acid-etched surface. Abutments/Screws: Commercially pure titanium (ASTM F67) or titanium alloy (ASTM F136). CoCr components: Cobalt-molybdenum alloy (ASTM F1537). Interface: External Hex (HE). Sterilization: Irradiation or steam sterilization. Connectivity: Standalone mechanical components.

Indications for Use

Indicated for patients requiring dental implants in the upper or lower jaw to support prosthetic devices (artificial teeth) for restoration of chewing function. Suitable for single or multiple unit restorations, single or two-stage surgical procedures, and immediate loading when primary stability and occlusal conditions are met.

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

• Neodent Implant System (K101207)

Reference Devices

• Replace TiUnite Endosseous Implant (K023113)
• Neoss ProActive Implant (K083561)
• Branemark System Self-Tapping Fixture (K925762)
• Neodent Implant System (K101945)
• Neoss TiBase and CoCr Abutments (K150669)
• External Hex Implants (K163634)
• Σ.Ι.N. Dental Implant System (K170398)
• Implacil Implant System (K183024)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

D.S.P Industrial Eireli % Graziela Brum Regulatory Affairs Specialist PR Servicos Regulatorios Administrarivos Ltda Rua Alice Alem Saadi, 855/2402 Ribeirao Preto, Sao Paulo 14096-570 BRAZIL

Re: K192839

Trade/Device Name: DSP Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: January 8, 2021 Received: January 12, 2021

# Dear Graziela Brum:

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.

Andrew Steen Assistant 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) K192839

Device Name

DSP Implant System

#### Indications for Use (Describe)

The DSP Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

| Type of Use (Select one or both, as applicable) | <label><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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# 510(k) Summary

# ADMINISTRATIVE INFORMATION

| Sponsor | D.S.P. Industrial Eireli |
|-----------------------------------|------------------------------------------------------------------------------|
| | Rua Marechal Floriano Peixoto 303 -Ouro Verde II |
| | Campo Largo, Paraná, Brazil 83606-290 |
| | Telephone [phone] |
| Prepared by | Janine Treter and Graziela Brum |
| | Passarini Regulatory Affairs |
| | PR Serviços Regulatórios Administrativos Ltda |
| | Email:[e-mail] |
| | Telephone [phone] |
| Date prepared | 10/Feb/2021 |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/ Proprietary Name | DSP Implant System |
| Common Name | Dental implant and dental implant abutment |
| Primary Classification Name | Endosseous dental implant |
| Primary Classification Regulation | 21 CFR 872.3640, Class II |
| Primary Product Code | DZE |
| Secondary Product Code | NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
| PREDICATE DEVICE INFORMATION | |
| Primary Predicate Device | K101207 - Neodent Implant System -JJGC Industria e Comercio de Materiais |
| | Dentarios S.A |
| Reference Devices | |
| | K023113 - Replace TiUnite Endosseous Implant - Nobel Biocare USA Inc |
| | K083561- Neoss ProActive Implant - Neoss Limited |
| | K925762 - Branemark System Self-Tapping Fixture - Nobelpharma USA, Inc |
| | K101945- Neodent Implant System - JJGC Industria e Comercio de Materiais |
| | Dentarios S.A. |
| | K150669 - Neoss TiBase and CoCr Abutments-Neoss Ltd. |
| | K163634 - - External Hex Implants - Southern Implants (Pty) Ltd. |
| | K170398 - Σ.Ι.N. Dental Implant System - S.I.N. Sistema de Implante Nacional |
| | S.A |
| | K183024 - Implacil Implant System -Implacil de Bortoli Material |
| | Odontologico Ltda |

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## INDICATIONS FOR USE

The DSP Implant System is intended to be surgically placed in the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

# SUBJECT DEVICE DESCRIPTION

DSP Implant System is composed of the External Hex (HE) implant line is composed of implants and related prosthetic components available in multiple designs.

DSP implants are made of commercially pure titanium (ASTM F67). DSP prosthetic components are made of commercially pure titanium or cobalt-molybdenum alloy (ASTM F1537). DSP implant system screws (abutment and prosthetic screws) are made of titanium alloy (ASTM F136).

The HE implant line is named after the External Hex implant-to-abutment interface. It is subdivided in External Hex SLIM (HE SLIM), External Hex BIOFIT), External Hex SOULFIT (HE SOULFIT), External Hex PROPFIT (HE PROPFIT) and External Hex WAYFIT). The HE implants are bone-level implants.

The subject device abutments components mate exclusively with the subject implants of the same line.

## COCR BASE UCLA

The CoCr Base UCLAs are prosthetic components to be installed onto DSP HE implants to support the definitive prosthesis. The CoCr Base UCLAs are composed of two parts: the CoCr alloy part that interfaces directly to the implant and a polymer cylinder part for fabrication of a cast prosthesis by a burnout technique. The cylinder part is made of polyoxymethylene polymer (POM) and the CoCr part is made of a Cobalt-Chromium-based alloy. They are supplied with a removable abutment screw made of titanium alloy in accordance with standard ASTM F136.

## COCR UCLA

The CoCr UCLAs are prosthetic components to be installed onto DSP HE implants to support the definitive prosthesis. The CoCr UCLAs interfaces directly to the implant and the top portion is cast out of CoCr metal using the lost-wax technique. They are supplied with a removable abutment screw made of titanium alloy in accordance with standard ASTM F136. The CoCr UCLA is a multi-unit abutment intended to be hand-milled to a patient-matched shape with a bridge or bar cast onto it.

## TITANIUM ABUTMENTS

The Titanium Abutments are intermediary prosthetic components to be installed onto DSP HE implants to support the definitive prosthesis. They are made of commercially pure titanium (Grade 4) conforming to ASTM F67. They are supplied with a removable abutment screw made of titanium alloy in accordance with standard ASTM F136. The Titanium Abutments it is the bottom half of a two-piece abutment. The second piece of this two-piece abutment is cast out of CoCr metal using the lost-wax technique. The two pieces are

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then cemented together. For the cementation, it is recommended to use dual resinous cement Panavia F (Kuraray Co Ltd Tokyo-Japan).

# COCR BASE COPINGS

The CoCr Base Copings are prosthetic components to be installed over the Mini Conical Abutment to support the definitive prosthesis. The CoCr Base Coping are composed of two parts: the CoCr alloy part that interfaces to the abutment and a polymer cylinder part for fabrication of a cast prosthesis by a burnout technique. The cylinder part is made of polyoxymethylene polymer (POM) and the CoCr part is made of a Cobalt-Chromiumbased alloy. They are supplied with a removable prosthetic screw made of titanium alloy in accordance with standard ASTM F136.

## MINI CONICAL ABUTMENTS

The Mini Conical Abutments are intermediary prosthetic components to be installed onto DSP implants (HE) to support the final prosthesis. They are made of commercially pure titanium (Grade 4) conforming to ASTM F67 and are supplied with a removable abutment screw made of titanium alloy in accordance with standard ASTM F136. The prosthesis is to be screw-retained over the Mini Conical Abutment.

Mini Conical Abutments are indicated multi-unit restorations only. They are to be used exclusively with a coping extending the abutment portion to a minimum of 4.9 mm.

# ONE STEP HYBRID TECHNIQUE

The One Step Hybrid Titanium Coping is a definitive prosthetic component intended for the One Step Hybrid Technique. It is made of commercially pure titanium (Grade 4) conforming to ASTM F67 and are supplied with a removable prosthetic screw made of titanium alloy in accordance with standard ASTM F136. The One Step Hybrid Titanium Coping is compatible with the HE Mini Conical Abutment. The prosthesis is to be cement-retained over the One Step Hybrid Titanium Coping.

## COVER

The Cover is a device intended for temporary use, made of commercially pure titanium (Grade 4) conforming to ASTM F67. In one end have fitting for a manual screwdriver that allows its installation and in the other, presents the interface for HE implants line coupling.

## HEALING ABUTMENT

The Healing Abutments are straight devices intended for temporary use, made of commercially pure titanium (Grade 4) conforming to ASTM F67. They are available in standard or anatomical shapes to be installed over the implant. In one end have fitting for its manual installation driver and in the other, present the interface compatible with the implant line (HE).

# PROTECTION CYLINDER

The Protection Cylinders are prosthetic components intended for temporary use, made of commercially pure titanium (Grade 4) conforming to ASTM F67. They are available in a cap shape to be installed over the Conventional Abutment (Mini Conical Abutment). In one of the ends it has a fit for the manual driver that

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allows its installation and in the other end the compatible geometry for installation over the abutment. It has a coupled screw for attachment on the corresponding abutment.

## TEMPORARY ABUTMENT

The Temporary Abutments are temporary prosthetic components to be installed onto DSP HE implants) to support provisional prosthesis. They are made of commercially pure titanium (Grade 4) conforming to ASTM F67 and are supplied with a removable abutment screw made of titanium alloy in accordance with standard ASTM F136. The prosthesis is to be cement-retained over the Temporary Abutment.

## ANATOMICAL ABUTMENTS

The Anatomical Abutments are intermediary prosthetic components to be installed onto DSP implants (HE) to support the final prosthesis. They are made of commercially pure titanium (Grade 4) conforming to ASTM F67. They are supplied with a removable abutment screw made of titanium alloy in accordance with standard ASTM F136. The prosthesis is to be cement-retained over the Anatomical Abutments.

## O'RING ABUTMENT

The O'ring abutments are straight ball-type intermediary prosthetic components to be installed onto DSP HE implants to support the final prosthesis. They are made of commercially pure titanium (Grade 4) conforming to ASTM F67.

The O'ring is indicated for the attachment of full or partial overdentures for multi-unit restorations.

## TEMPORARY COPINGS

The Temporary Copings are temporary coping-type prosthetic components to be installed over a Conventional Abutment (HE), specifically, the Temporary Copings are screw-retained on the Mini Conical Abutments. They are made of commercially pure titanium (Grade 4) conforming to ASTM F67 and are supplied with a removable prosthetic screw made of titanium alloy in accordance with standard ASTM F136. The prosthesis is to be cement over the Temporary Copings.

## ABUTMENT SCREW

The Abutment Screws (Temporary Abutment, UCLA-type Abutment or Conventional Abutment) are manufactured in titanium alloy in accordance with ASTM F136 - Ti6Al4V-ELI. They are composed of two different parts: head and body. The head has a geometry for the Driver/Connection which enable its use; and the body has a thread with a geometry which allow its fixation.

## PROSTHETIC SCREWS

The Prosthetic Screws are manufactured in titanium alloy in accordance with ASTM F136 - Ti6Al4V-ELI. They are intended to connect the prosthesis in the Conventional Abutments, specifically, the Mini Conical Abutments. The Prosthetic Screws are composed of two different parts: head and body. The head has a geometry for the fitting of the Driver/Connection which enable its use; and the body has a thread with a geometry which allow its fixation.

## TECHNOLOGICAL CHARACTERISTICS

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The subject devices indications for use statement is equivalent to the primary predicate device K101207. The phrase "multiple tooth application may be rigidly splinted" was suppressed since it is up to the professional in charge to select proper technique for multi-unit restoration. The indication for use of the subject device is within the scope of the reference devices. Refer to table 5.1.

Differences in the design features between the subject devices and primary predicate devices K101207 are addressed by comparison to the reference devices in the tables 5.2 to 5.17 below.

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| Table 5.1: SE comparison on Indication for Use Statements | | |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | KNUMBER/ MANUFACTURER | INDICATION FOR USE STATEMENT |
| SUBJECT DEVICE | K192839 - DSP Implant System<br>D.S.P. Industrial Eireli | The DSP Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic<br>devices, such as artificial teeth, to restore chewing function. It may be used with single stage or two-stage procedures, for single or<br>multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal<br>loading. |
| PRIMARY PREDICATE<br>DEVICE | K101207 - Neodent Implant System<br>JJGC Industria e Comercio de Materiais<br>Dentarios S.A. | The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic<br>devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or<br>multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal<br>loading. Multiple tooth applications may be rigidly splinted. |
| REFERENCE DEVICES | K023113 - Replace TiUnite Endosseous<br>Implant<br>Nobel Biocare USA Inc | The Nobel Biocare Replace TiUnite Endosseous Implant is intended to be placed in theupper or lower jaw to support prosthetic devices<br>such as artificial teeth, and to restore patient's chewing function, This may be accomplished using a two stage surgical procedure or a<br>single stage surgical procedure. If the single stage surgical procedure is used, these implants may be loaded immediately following<br>insertion - provided - at least four implants are placed and splinted with a bar. These implants must be placed predominantly in the<br>anterior mandible (between the mental foraminae) where good initial stability of the implants with or without bi-cortical anchorage, can<br>most often be obtained. |
| | K083561- Neoss ProActive Implant<br>Neoss Limited | The Neoss ProActive Implant is for single-stage and two-stage surgical procedures and cement or screw retained restorations.<br>The Neoss ProActive Implant are intended for immediate placement and function on single tooth and /or multiple tooth applications<br>recognizing sufficient bone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be<br>splinted with a bar. |
| | K925762 - Branemark System Self-Tapping<br>Fixture<br>Nobelpharma USA, Inc | The Nobelpharma Branemark System® - Self-Tapping Fixture is intended to be used in edentulous and partially edentulous patients to restore<br>chewing functions of those patients. |
| | K101945- Neodent Implant System | The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support fqr prosthetic<br>devices such as artificial teeth, to restore chewing function It may be used with single-stage or two-stage procedures for single or |
| KNUMBER/ MANUFACTURER | INDICATION FOR USE STATEMENT | |
| JJGC Industria e Comercio de Materiais<br>Dentarios S.A. | multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal<br>loading. Multiple tooth applications may be rigidly splinted. | |
| K150669 - Neoss TiBase and CoCr<br>Abutments | Neoss TiBase:<br>Neoss Abutments are designed to be connected to the Neoss Implants and intended for use as an aid in prosthetic rehabilitation. | |
| Neoss Ltd. | The Neoss TiBase is compatible with the Sirona Dental System inCoris ZI Meso L. All digitally designed copings and/or crowns for use<br>with the Neoss TiBase Abutments are to be designed and milled using the Sirona Dental CAD/CAM System.<br>Neoss CoCr Abutments:<br>Neoss abutments are designed to be connected to the Neoss Implants and intended for use as an aid in prosthetic rehabilitation. | |
| K170398 - S.I.N. Dental Implant System | S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-<br>unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading<br>when good primary stability is achieved and with appropriate occlusal loading. Implants with lengths less than 7 mm are intended for<br>delayed loading only. | |
| S.I.N. Sistema de Implante Nacional S.A | | |
| K163634 - - External Hex Implants | Southern Implants' External Hex Implants are intended for surgical placement in the upper or lower jaw to provide a means for<br>prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. Southern Implants' External Hex<br>Implants are intended for immediate function when good primary stability with appropriate occlusal loading is achieved. | |
| Southern Implants (Pty) Ltd | | |
| K183024 – Implacil Implant System | Implacil Implant System is intended for placement in the maxillary or mandibular arch to provide support forsingle-unit and/or multi-<br>unit restorations. When a one-stage surgical approach is applied, the Implacil Implant System is intended for immediate loading when<br>good primary stability is achieved and with appropriate occlusal loading. | |
| Implacil de Bortoli Material Odontologico<br>Ltda | | |

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| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICES | |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name<br>Information | K192839 - DSP Implant System | K101207 – Neodent Implant System | K023113 - Replace TiUnite Endosseous<br>Implant | K170398 - S.I.N. Dental Implant System |
| | D.S.P. Industrial Eireli | JJGC Industria e Comercio de Materiais<br>Dentarios S.A. | Nobel Biocare USA Inc | S.I.N. Sistema de Implante Nacional S.A. |
| HE SLIM | | | | |
| Implant-to-abutment<br>connection | HE | HE | Internal tri-channel | HE |
| Root-type design | Cylindrical | Cylindrical<br>Tapered | Tapered | Cylindrical |
| Prosthesis attachment | Screw-retained<br>Cement-retained<br>Overdenture | Screw-retained<br>Cement-retained<br>Overdenture | Screw-retained<br>Cement-retained<br>Overdenture | Screw-retained<br>Cement-retained<br>Overdenture |
| Restoration | Single-unit<br>Multi-unit | Single-unit<br>Multi-unit | Single-unit<br>Multi-unit | Single-unit<br>Multi-unit |
| Implant diameter: Length<br>(mm) | Cylindrical<br>3.3: 8.5, 10, 11.5, 13, 15, 17 | Cylindrical:<br>3.3: 9, 11, 13, 15, 17<br>3.75: 9, 11, 13, 15, 17, 19<br>4.0: 9, 11, 13, 15, 17, 19<br>4.5: 9, 11, 13<br>5.0: 7, 9, 11, 13<br>Tapered:<br>3.5: 10, 13, 16<br>4.3: 10, 13, 16<br>5.0: 10, 13, 16 | Tapered:<br>3.5: 10, 13, 16<br>4.3: 10, 13, 16<br>5.0: 10, 13, 16<br>6.0: 10, 13, 16 | Cylindrical:<br>3.25: 8.5, 10, 11.5, 13, 15<br>3.5: 7, 8.5, 10, 11.5, 13, 15<br>3.75: 7, 8.5, 10, 11.5, 13, 15<br>4.0: 6, 7, 8.5, 10, 11.5, 13, 15<br>4.5: 8.5, 10, 11.5, 13, 15<br>5.0: 6, 7, 8.5, 10, 11.5, 13, 15 |
| Raw Material | CPTi Gr4 | CPTi Gr4 | CPTi Gr4 (cold worked titanium) | CPTi Gr4 |
| Surface | Treated. Grit-blasted and acid-etched.<br>Machined collar: h 1.0 mm | Treated. Grit-blasted and acid-etched. | Treated, TiUnite<br>Machined collar: h 1.5 mm | Treated. Acid-etched and HA<br>Machined collar: h 0.7 mm |
| | | Treated collar :<br>h unknown | | |
| Sterilization | Provided sterile by irradiation | Provided sterile by irradiation | Provided sterile by irradiation | Provided sterile by irradiation |
| Table 5.3: SE comparison on HE BIOFIT implants | | | | |
| SUBJECT DEVICE | | REFERENCE DEVICES | | |
| Trade Name<br>Information | K192839 - DSP Implant System | K083561- Neoss ProActive Implant | K023113 - Replace TiUnite Endosseous<br>Implant | K170398 - S.I.N. Dental Implant System |
| | D.S.P. Industrial Eireli | Neoss Limited | Nobel Biocare USA Inc | S.I.N. Sistema de Implante Nacional S.A. |
| HE BIOFIT | | | | |
| Implant-to-abutment<br>connection | HE | Internal Hex (NeoLoc) | Internal tri-channel | HE |
| Root-type design | Cylindrical | Cylindrical | Tapered | Cylindrical |
| Prosthesis attachment | Screw-retained | Screw-retained | Screw-retained | Screw-retained |
| | Cement-retained | Cement-retained | Cement-retained | Cement-retained |
| | Overdenture | Overdenture | Overdenture | Overdenture |
| Restoration | Single-unit | Single-unit | Single-unit | Single-unit |
| | Multi-unit | Multi-unit | Multi-unit | Multi-unit |
| Implant diameter: Length<br>(mm) | Cylindrical:<br>3.5: 8.1, 9.6, 11.1, 12.6, 14.6, 16.6<br>3.75: 7, 8.1, 9.6, 11.1, 12.6, 14.6, 16.6<br>4.0:, 7, 8.1, 9.6, 11.1, 12.6, 14.6<br>4.5: 7, 8.1, 9.6, 11.1, 12.6, 14.6, 16.6<br>5.0: 7, 8.1, 9.6, 11.1, 12.6 | Cylindrical:<br>3.5: 7, 9, 11, 13, 15, 17<br>4.0: 7, 9, 11, 13, 15, 17<br>4.5: 7, 9, 11, 13, 15, 17<br>5.0: 7, 9, 11, 13, 15<br>5.5: 7, 9, 11, 13 | Tapered:<br>3.5: 10, 13, 16<br>4.3: 10, 13, 16<br>5.0: 10, 13, 16<br>6.0: 10, 13, 16 | Cylindrical:<br>3.25: 8.5, 10, 11.5, 13, 15<br>3.5: 7, 8.5, 10, 11.5, 13, 15<br>3.75: 7, 8.5, 10, 11.5, 13, 15<br>4.0: 6, 7, 8.5, 10, 11.5, 13, 15<br>4.5: 8.5, 10, 11.5, 13, 15<br>5.0: 6, 7, 8.5, 10, 11.5, 13, 15 |
| Raw Material | CPTi Gr4 | Not informed | CPTi Gr4 (cold worked titanium) | CPTi Gr4 |
| Surface | Treated. Grit-blasted and acid-etched | Treated. Grit-blasted and acid-etched | Treated, TiUnite | Acid-etched and HA |
| | Machined collar: h 0.3 mm | Treated collar: h unknown | Machined collar: h 1.5 mm | Machined collar: h 0.7 mm |
| Sterilization | Provided sterile by irradiation | Provided sterile. Method not informed. | Provided sterile by irradiation | Provided sterile by irradiation |
| Table 5.4: SE comparison on HE SOULFIT implants | | | | |
| | SUBJECT DEVICE | REFERENCE DEVICES | | |
| Trade Name<br>Information | K192839 - DSP Implant System | K023113 - Replace TiUnite Endosseous<br>Implant | K925762 - Branemark System Self-<br>Tapping Fixture | K170398 - S.I.N. Dental Implant System |
| | D.S.P. Industrial Eireli | Nobel Biocare USA Inc | Nobelpharma USA, Inc | S.I.N. Sistema de Implante Nacional S.A. |
| HE SOULFIT | | | | |
| Implant-to-abutment<br>connection | HE | Internal tri-channel | HE | HE |
| Root-type design | Cylindrical | Tapered | Cylindrical | Cylindrical |
| Prosthesis attachment | Screw-retained<br>Cement-retained<br>Overdenture | Screw-retained<br>Cement-retained<br>Overdenture | Screw-retained<br>Cement-retained<br>Overdenture | Screw-retained<br>Cement-retained<br>Overdenture |
| Restoration | Single-unit<br>Multi-unit | Single-unit<br>Multi-unit | Single-unit<br>Multi-unit | Single-unit<br>Multi-unit |
| Implant diameter: Length | Cylindrical:<br>3.5: 8.5, 10, 11.5, 13, 15<br>3.75: 7, 8.5, 10, 11.5, 13, 15, 17<br>4.0: 7, 8.5, 10, 11.5, 13, 15, 17<br>5.0: 7, 8.5, 10, 11.5, 13 | Tapered:<br>3.5: 10, 13, 16<br>4.3: 10, 13, 16<br>5.0: 10, 13, 16<br>6.0: 10, 13, 16 | Cylindrical:<br>3.3: 10, 11.5, 13, 15<br>3.75: 7, 8.5, 10, 11.5, 13, 15, 18<br>4.0: 7, 8.5, 10, 11.5, 13, 15, 18<br>5.0: 7, 8.5, 10, 11.5, 13, 15, 18 | Cylindrical:<br>3.25: 8.5, 10, 11.5, 13, 15<br>3.5: 7, 8.5, 10, 11.5, 13, 15<br>3.75: 7, 8.5, 10, 11.5, 13, 15<br>4.0: 6, 7, 8.5, 10, 11.5, 13, 15<br>4.5: 8.5, 10, 11.5, 13, 15<br>5.0: 6, 7, 8.5, 10, 11.5, 13, 15 |
| Raw Material | CPTi Gr4 | CPTi Gr4 (cold worked titanium) | CPTi Gr4 | CPTi Gr4 |
| Surface | Treated. Grit-blasted and acid-etched<br>Machined collar: h max 0.8 mm | Treated, TiUnite<br>Machined collar: h 1.5 mm | Treated. Grit-blasted and acid-etched.<br>Machined collar: h 0.8 mm…