Neodent Implant System-Easy Pack

K203382 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · DZE · Mar 15, 2021 · Dental

Device Facts

• Record ID: K203382
• Device Name: Neodent Implant System-Easy Pack
• Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
• Product Code: DZE · Dental
• Decision Date: Mar 15, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Neodent 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. The GM Easy Pack System is indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months.

Device Story

Neodent Implant System-Easy Pack consists of endosseous dental implants, cover screws, and abutments (GM Smart, GM Healing). Implants are surgically placed in the jawbone to support prosthetic restorations. The GM Smart Abutment functions as a scanbody, conventional closed tray transfer, or temporary component for up to 180 days. The system uses a Grand Morse (GM) connection interface. Implants are manufactured from unalloyed titanium (ASTM F67); abutments and screws from titanium alloy (ASTM F136). Devices are provided sterile via Gamma Radiation or Ethylene Oxide. Used in dental clinics by licensed dentists. Output is a stable foundation for prosthetic teeth, enabling chewing function restoration. Benefits include improved oral function and aesthetics for patients with missing teeth.

Clinical Evidence

Bench testing only. No clinical data provided. Performance validated via mechanical testing (torsion, insertion, dynamic fatigue), biocompatibility (cytotoxicity, corrosion, genotoxicity, chemical characterization), sterilization validation (Gamma, EO, steam), packaging integrity (sealing strength, dye penetration, bubble test), and MRI compatibility assessment (ASTM F2052, F2213, F2182, F2119).

Technological Characteristics

Implant: Unalloyed titanium (ASTM F67). Abutments/Screws: Titanium alloy Ti6Al4V-ELI (ASTM F136). Interface: Grand Morse (GM) connection. Surface: Neoporos/Acqua. Sterilization: Gamma Radiation or Ethylene Oxide (SAL 10^-6). Dimensions: Implants 3.5-4.3mm diameter, 8-13mm length. Abutments 3.5-4.5mm diameter, 1.5-3.5mm gingival height. Standalone mechanical device.

Indications for Use

Indicated for patients requiring dental implants to support prosthetic devices (artificial teeth) for chewing function restoration. Suitable for single or multiple unit restorations in upper or lower jaw, using single or two-stage procedures. Immediate loading permitted with good primary stability. GM Easy Pack components provide temporary prosthetic support for up to 6 months.

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 - GM Line (K163194)

Reference Devices

• Neodent Implant System - Temporary Abutments (K191191)
• MRI Compatibility for Existing Neodent Implant System (K182620)
• Change in the Shelf Life for Neodent Acqua Implants (K193592)

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.

JJGC Industria e Comercio de Materiais Dentarios S.A. % Jennifer Jackson Director of Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810

Re: K203382

Trade/Device Name: Neodent Implant System-Easy Pack Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: February 11, 2021 Received: February 12, 2021

Dear Jennifer Jackson:

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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# Indications for Use

510(k) Number (if known) K203382

Device Name Neodent Implant System - Easy Pack

### Indications for Use (Describe)

The Neodent 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. The GM Easy Pack System is indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <b> ☑ </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# ADMINISTRATIVE INFORMATION

| Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA<br>(dba Neodent)<br>Av. Juscelino Kubitschek de Oliveira, 3291<br>Curitiba, Parana, Brazil 81270-200<br>Registration No.: 3008261720<br>Owner/Operator No.: 10031702 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Jennifer M. Jackson, MS<br>Director of Regulatory Affairs,<br>Straumann USA<br>E-mail: [e-mail]<br>Telephone [phone] |
| Date Prepared | 15/Mar/2021 |
| Preparer / Alternate Contact | Mariana Soares Hartmann<br>Regulatory Affairs Analyst<br>JJGC Indústria e Comércio de Materiais Dentários SA<br>E-mail: [e-mail] |

# DEVICE NAME AND CLASSIFICATION

| Trade/ Proprietary Name | Neodent Implant System – Easy Pack |
|----------------------------|----------------------------------------------------------------------|
| Common Name | Endosseous dental implant<br>Endosseous dental implant abutment |
| Classification Name | Implant, Endosseous, Root-form<br>Endosseous dental implant abutment |
| Classification Regulations | 21 CFR 872.3640, Class II |
| Product Code | Primary: DZE<br>Secondary: NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |

# PREDICATE DEVICE INFORMATION

| Primary Predicate Device | K163194 | - Neodent Implant System - GM Line, JJGC Indústria e<br>Comércio de Materiais Dentários S.A |
|----------------------------|---------|------------------------------------------------------------------------------------------------------------------|
| Reference Predicate Device | K191191 | - Neodent Implant System - Temporary Abutments, JJGC<br>Indústria e Comércio de Materiais Dentários S.A |
| Reference Predicate Device | K182620 | - MRI Compatibility for Existing Neodent Implant System, JJGC<br>Indústria e Comércio de Materiais Dentários S.A |
| Reference Predicate Device | K193592 | - Change in the Shelf Life for Neodent Acqua Implants, JJGC<br>Indústria e Comércio de Materiais Dentários S.A |

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### INDICATIONS FOR USE

The Neodent 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. The GM Easy Pack System is indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months.

### SUBJECT DEVICE DESCRIPTIONS

- Intended for single use;
- The subject GM Helix Implants are available in diameters of 3.5, 3.75, 4.0 and 4.3 mm and in heights of 8, 10, 11.5 and 13 mm;
- The subject GM Smart Abutments are available in diameters of 3.5 and 4.5 mm and gingival heights of 1.5, 2.5 and 3.5 mm. The GM Smart Abutments can be customized respecting a minimum post height of 4 mm. The GM Smart Abutments are being presented for the first time for FDA's evaluation;
- . All digitally designed copings and/or crowns to be used with the GM Smart Abutments are intended to be sent to Straumann for manufacture at a validated milling center;
- . The subject GM Healing Abutments are available in diameters of 3.5 and 4.5 mm and gingival heights of 1.5, 2.5 and 3.5 mm;
- . Implant and Cover Screw delivered sterile via Gamma Radiation;
- Sterile Abutments provided sterile via Ethylene Oxide;
- The subject implant is manufactured of unalloyed titanium grade 4, according to ASTM F67;
- . The GM Cover Screw, GM Smart Abutment, GM Healing Abutment and the Removable Screw are manufactured in titanium alloy Ti6Al4V-ELI according to ASTM F136;
- The GM Helix Implants, Acqua and Neoporos, the GM Cover Screw and the Healings subject of this submission are exactly the same devices already cleared to market per K163194;
- . The GM Smart abutments, subject of this submission, are new abutments being introduced in this premarket notification;
- . The implant to abutment interface is a Grand Morse (GM) connection.

The compatibility table for both GM Helix implants and GM Smart abutments is presented below (all combinations available within each row):

| Implant Diameter | Implant Length | Abutment diameter | Abutment Gingival Heights |
|------------------|--------------------|-------------------|---------------------------|
| 3.5 mm | 8, 10, 11.5, 13 mm | 3.5 and 4.5 mm | 1.5, 2.5, 3.5 mm |
| 3.75 mm | 8, 10, 11.5, 13 mm | 3.5 and 4.5 mm | 1.5, 2.5, 3.5 mm |
| 4.0 mm | 8, 10, 11.5, 13 mm | 3.5 and 4.5 mm | 1.5, 2.5, 3.5 mm |
| 4.3 mm | 8, 10, 11.5, 13 mm | 4.5 mm | 1.5, 2.5, 3.5 mm |

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# TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLES

| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | | |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Neodent Implant System - Easy Pack System<br>JJGC Indústria e Comércio de Materiais Dentários S.A. | K163194<br>Neodent Implant System - GM Line<br>JJGC Indústria e Comércio de Materiais Dentários S.A. | Equivalence<br>Discussion | |
| Indications for Use | The Neodent Implant System is intended to be<br>surgically placed in the bone of the upper or lower jaw<br>to provide support for prosthetic devices, such as<br>artificial teeth, to restore chewing function. It may be<br>used with single-stage or two-stage procedures, for<br>single or multiple unit restorations, and may be<br>loaded immediately when good primary stability is<br>achieved and with appropriate occlusal loading. The<br>GM Easy Pack System is indicated to be used on<br>Neodent implants to provide temporary support for<br>prosthesis structure for up to 6 months. | for GM implants and conventional abutments:<br>The Neodent Implant System is intended to be<br>surgically placed in the bone of the upper or lower jaw<br>to provide support for prosthetic devices such as<br>artificial teeth, to restore chewing function. It may be<br>used with single-stage or two-stage procedures, for<br>single or multiple unit restorations, and may be<br>loaded immediately when good primary stability is<br>achieved and with appropriate occlusal loading.<br><br>for GM Titanium Base abutments:<br>Titanium Base Abutment is a titanium base placed<br>onto Neodent dental implants to provide support for<br>customized prosthetic restorations. It is used with a<br>coping and crown, or crown alone, and is indicated for<br>cement-retained single or multi-unit restorations, or<br>screw-retained single restorations. All digitally<br>designed copings and/or crowns for use with the<br>Neodent Titanium Base Abutment System are<br>intended to be sent to Straumann for manufacture at<br>a validated milling center.<br><br>for GM Pro Peek Abutments:<br>The Pro PEEK Abutments are indicated to be used on<br>Neodent implants to provide temporary support for<br>prosthesis structure for up to 6 months. They can be<br>used in one or two stage procedures and also<br>immediate load when there is good primary stability. | Similar<br>Subject devices and predicate devices share the same<br>indications for use. The predicate for the subject<br>implants and cover screw is the GM implants and<br>conventional abutments of K163194. The temporary<br>indication is covered by the GM Pro Peek Abutments of<br>K163194. | |
| Implant-Abutment<br>interface | GM Morse Taper | GM Morse Taper | Identical<br>Subject devices and predicate devices present the<br>same Implant-to-abutment interface. | |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | | |
| | Neodent Implant System - Easy Pack System<br>JJGC Indústria e Comércio de Materiais Dentários S.A. | K163194<br>Neodent Implant System - GM Line<br>JJGC Indústria e Comércio de Materiais Dentários S.A. | Equivalence<br>Discussion | |
| Implant Design | Conical shape, double threads with trapezoidal<br>profile, rounded apex | Conical shape, double threads with trapezoidal<br>profile, rounded apex | Identical<br>Subject devices and predicate devices present the<br>same design | |
| Cover Screw Design | One end with a slot for the recommended<br>driver/connection and the other end with an<br>interface compatible with the GM prosthetic<br>interface | One end with a slot for the recommended<br>driver/connection and the other end with an interface<br>compatible with the GM prosthetic interface | Identical<br>Subject devices and predicate devices present the<br>same design | |
| Reusable | No | No | Identical<br>The subject devices and the predicate devices are<br>indicated for single use. | |
| Implant Diameter (Ø)<br>(mm) | 3.5, 3.75, 4.0 and 4.3 mm | 3.5, 3.75, 4.0, 4.3 and 5.0 mm | Equivalent<br>Diameter of subject devices is within the range of<br>diameters for the primary and reference predicate<br>devices, so the subject devices do not represent a worst<br>case in terms of performance. | |
| Implant Length (mm) | 8, 10, 11.5 and 13 mm | 8, 10, 11.5, 13, 16 and 18 mm | Equivalent<br>Range of lengths for subject devices is within the<br>range of lengths for the primary and reference<br>predicate devices. | |
| Material | Implant - Titanium grade 4 conforming to ASTM F67<br>Cover Screw - Titanium alloy conforming to ASTM<br>F136 | Implant - Titanium grade 4 conforming to ASTM F67<br>Cover Screw - Titanium alloy conforming to ASTM<br>F136 | Identical<br>Subject devices and predicate devices are<br>manufactured of the same raw material | |
| Surface | Neoporos<br>Acqua | Neoporos<br>Acqua | Identical<br>Subject devices and predicate devices present the<br>same surface | |
| Sterilization Method | Provided sterile via Gamma Radiation to an SAL of<br>1x10-6 | Implant - Provided sterile via Gamma Radiation to an<br>SAL of 1x10-6<br>Cover Screw - Provided sterile via Ethylene Oxide to an<br>SAL of 1x10-6 | Equivalent<br>Subject devices and predicate devices are provided<br>sterile by the same sterilization method.<br>The subject Cover Screw provided along with the Implant<br>is delivered sterile via Gamma Irradiation and when<br>commercialized separately, provided sterile via Ethylene<br>Oxide. Detailed information are provided in Section 14. | |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | Equivalence<br>Discussion |
| | Neodent Implant System - Easy Pack System<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | K163194<br>Neodent Implant System - GM Line<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | K191191<br>Neodent Implant System - Temporary<br>Abutments<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | |
| Indications<br>for Use | The Neodent Implant System is intended to be<br>surgically placed in the bone of the upper or<br>lower jaw to provide support for prosthetic<br>devices, such as artificial teeth, to restore<br>chewing function. It may be used with single-<br>stage or two-stage procedures, for single or<br>multiple unit restorations, and may be loaded<br>immediately when good primary stability is<br>achieved and with appropriate occlusal<br>loading. The GM Easy Pack System is indicated<br>to be used on Neodent implants to provide<br>temporary support for prosthesis structure for<br>up to 6 months. | for GM implants and conventional abutments:<br>The Neodent Implant System is intended to be<br>surgically placed in the bone of the upper or<br>lower jaw to provide support for prosthetic<br>devices such as artificial teeth, to restore<br>chewing function. It may be used with single-<br>stage or two-stage procedures, for single or<br>multiple unit restorations, and may be loaded<br>immediately when good primary stability is<br>achieved and with appropriate occlusal<br>loading.<br><br>for GM Titanium Base abutments:<br>Titanium Base Abutment is a titanium base<br>placed onto Neodent dental implants to<br>provide support for customized prosthetic<br>restorations. It is used with a coping and<br>crown, or crown alone, and is indicated for<br>cement-retained single or multi-unit<br>restorations, or screw-retained single<br>restorations. All digitally designed copings<br>and/or crowns for use with the Neodent<br>Titanium Base Abutment System are intended<br>to be sent to Straumann for manufacture at a<br>validated milling center.<br><br>for GM Pro Peek Abutments:<br>The Pro PEEK Abutments are indicated to be<br>used on Neodent implants to provide<br>temporary support for prosthesis structure for<br>up to 6 months. They can be used in one or<br>two stage procedures and also immediate<br>load when there is good primary stability. | The Neodent Implant System is intended to be<br>surgically placed in the bone of the upper or<br>lower jaw to provide support for prosthetic<br>devices, such as artificial teeth, to restore<br>chewing function. It may be used with single-<br>stage or two-stage procedures, for single or<br>multiple unit restorations, and may be loaded<br>immediately when good primary stability is<br>achieved and with appropriate occlusal<br>loading. The Neodent Implant System -<br>Temporary Abutments are indicated to be<br>used on Neodent implants to provide<br>temporary support for prosthesis structure for<br>up to 6 months. | Similar<br>Subject devices and predicate devices<br>share similar indications for use. Subject<br>devices present the same indications for<br>use as reference predicate devices<br>(K191191). |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | |
| | Neodent Implant System - Easy Pack System<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | K163194<br>Neodent Implant System - GM Line<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | K191191<br>Neodent Implant System - Temporary<br>Abutments<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | Equivalence<br>Discussion |
| Intended Use | GM Smart Abutment: Hybrid component that<br>has three functions. It can be used as a<br>scanbody, conventional closed tray transfer or<br>temporary component. With scanbody<br>function, the product is used to transfer the<br>position and orientation of the implants to the<br>digital model (scan) or plaster model<br>(conventional). For use as a temporary<br>component, the GM Smart Abutment is used<br>for temporary rehabilitation (up to 180 days)<br>with screw retrained single-unit protheses.<br>The GM Smart Abutment is only used with<br>implants placed straight (i.e no divergence)<br>and is available in the GM prosthetic interface<br>and must be used only with implants of<br>corresponding interface. | | The Temporary Abutment is used for<br>temporary rehabilitation (up to 180 days) with<br>screw retained single-unit (antirotational<br>abutment) or multi-unit (rotational abutment)<br>prostheses.<br>Temporary Abutments are only to be used<br>with implants placed straight (i.e. no<br>divergence).<br>This product is available in the GM prosthetic<br>interface and must be used only with implants<br>of corresponding interface. | Similar<br>The scanbody and conventional closed<br>tray transfer applications are exempt of<br>registration, so it is not being<br>considered in the comparison. The GM<br>Smart Abutment application as<br>temporary abutment is similar to the<br>Temporary Abutment of K191191. |
| Implant-<br>Abutment<br>interface | GM Morse Taper | GM Morse Taper | GM Morse Taper | Identical<br>Subject devices and predicate devices<br>present the same Implant-to-abutment<br>interface. |
| Reusable | No | No…