Neodent Implant System - Helix Short Implant System

K223638 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · DZE · Jun 23, 2023 · Dental

Device Facts

• Record ID: K223638
• Device Name: Neodent Implant System - Helix Short Implant System
• Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
• Product Code: DZE · Dental
• Decision Date: Jun 23, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Neodent Implant System is recommended for surgical procedures on maxilla or mandible bones. It provides support for prosthetic components such as artificial teeth, thus restoring the 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

Neodent Implant System - Helix Short Implant System comprises endosseous dental implants, abutments, and prosthetic components. Implants are surgically placed in maxilla or mandible bone to support artificial teeth. System utilizes internal hex interface; cylindrical body; double threads; conical apex with three helical flutes. Implants feature NeoPoros (sand-blasted/acid-etched) or Acqua (hydrophilic) surfaces. Titanium bases support customized CAD/CAM-milled copings/crowns. Used by dentists/oral surgeons in clinical settings. Provides stable foundation for prosthetic restorations; restores chewing function; enables immediate loading protocols. Output is physical support for dental prostheses. Benefits include restoration of oral function and aesthetics for edentulous or partially edentulous patients.

Clinical Evidence

Bench testing only. Includes dynamic fatigue testing (ISO 14801), static torsion testing, insertion torque evaluation, implant surface area simulation, and pull-out resistance testing. Biocompatibility assessed per ISO 10993-1, -5, -7, -12, and -18. MR compatibility assessment performed. Sterilization validated per ISO 11137 and ISO 11135. Endotoxin testing performed per FDA guidance.

Technological Characteristics

Materials: Commercially Pure Titanium Grade 4 (ASTM F67) for implants; Titanium alloy Ti-6Al-4V ELI (ASTM F136) for abutments/screws. Interface: Internal hex. Surface: NeoPoros (sand-blasted/acid-etched) or Acqua (hydrophilic). Sterilization: Gamma irradiation (implants) or Ethylene Oxide (abutments) to SAL 10^-6. Form factor: Cylindrical, 3.75-7.0mm diameter, 4.0-8.5mm length. Connectivity: None (mechanical).

Indications for Use

Indicated for surgical placement in maxilla or mandible bone to support prosthetic devices (artificial teeth) for chewing function restoration. Suitable for single/multiple unit restorations, single/two-stage procedures, and immediate loading given sufficient primary stability. Includes specific components: healing abutments/cover screws for soft tissue maintenance during bone integration; temporary abutments for up to 6 months; titanium bases for customized copings/crowns.

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

• Straumann TLX Implant System (K200586)
• Neodent Implant System (K123022)
• Straumann 4 mm Short Implants (K202942)
• NUVO CF Implant System (K203309)
• Neodent Implant System - Narrow Implant System (K220251)
• MRI Compatibility For Existing Neodent Implant System (K182620)

Submission Summary (Full Text)

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

Re: K223638

Trade/Device Name: Neodent Implant System - Helix Short Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 17, 2023 Received: May 25, 2023

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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

#### 510(k) Number (if known) K223638

#### Device Name

Neodent Implant System - Helix Short Implant System

#### Indications for Use (Describe)

Indications for Use for Helix Short Implant:

The Neodent Implant System is recommended for surgical procedures on maxilla or mandible bones. It provides support for prosthetic components such as artificial teeth, thus restoring the 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.

#### Indications for Use for Mini Straight, Angled Abutment and screws:

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.

#### Indications for Use for Helix Short Attachment:

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 procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Indications for Use for Helix Short Healing Abutment:

This product is used for the maintenance of soft tissue, during the bone integration stage of Neodent implants to be rehabilitated with the late loading technique. The Healing Abutment may be used in the implant installation surgery or the reopening surgery (second surgical stage).

Indications for Use for Helix Short Cover Screw:

This product is used for the maintenance of soft tissue, during the bone integration stage of Neodent implants to be rehabilitated with the late loading technique. The Cover Screw must remain intragingival, preventing the growth of tissue over the implant platform. The Cover Screw takes place in the conical region of the implant interface.

#### Indications for Use for Temporary Abutment for Helix Short Implant

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 procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Temporary Abutments are installed over Helix Short Implants and to provide support for prosthetic structures for up to 6 months.

Indications for Use for Helix Short Titanium Base:

The Helix Short Implant Titanium base that is placed over Neodent dental implants to provide support for customized prosthetic restorations, such as copings and crowns. It is indicated for single- and multiple-structure restorations, screw- or cement-retained on implants installed in the maxilla or mandible. All digitally-designed copings and/or crowns to be used with the Neodent Titanium Base System must be sent to Straumann for manufacture at a validated milling center.

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Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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| 510(k) Summary | |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ADMINISTRATIVE INFORMATION | |
| Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA<br>(dba Neodent)<br>Av. Juscelino Kubitschek de Oliveira, 3291<br>Curitiba, Paraná, 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 | 22/June/2023 |
| Preparer / Alternate Contact | Bárbara Uzae<br>Regulatory Affairs Analyst<br>E-mail: [e-mail] |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/Proprietary Name<br>Common Name | Neodent Implant System – Helix Short Implant System<br>Endosseous dental implant |
| Classification Name | Endosseous dental implant |
| Classification Regulations<br>Product Code | 21 CFR 872.3640, Class II / 21 CFR 872.3630, Class II<br>DZE/NHA |
| Classification Panel<br>Reviewing Branch | Dental Products Panel<br>Dental Devices Branch |
| PREDICATE DEVICE INFORMATION | |
| Primary Predicate Device | K163194, Neodent Implant System - GM Line, JJGC<br>Indústria e Comércio de Materiais Dentários S.A |
| Reference Devices | K200586 - Straumann TLX Implant System, Institut<br>Straumann AG<br>K123022 - Neodent Implant System, JJGC Indústria e<br>Comércio de Materiais Dentários S.A |

## 510(k) Summary

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K202942 - Straumann® 4 mm Short Implants, Straumann USA, LLC

K203309 – NUVO CF Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A

K220251 - Neodent Implant System - Narrow Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A

K182620 - MRI Compatibility For Existing Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A

#### INDICATIONS FOR USE

## Indications for Use for Helix Short Implant:

The Neodent Implant System is recommended for surgical procedures on maxilla or mandible bones. It provides support for prosthetic components such as artificial teeth, thus restoring the 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.

## Indications for Use for Mini Straight, Angled Abutment and screws:

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.

## Indications for Use for Helix Short Attachment:

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.

## Indications for Use for Helix Short Healing Abutment:

This product is used for the maintenance of soft tissue, during the bone integration stage of Neodent implants to be rehabilitated with the late loading technique. The Healing Abutment may be used in the implant installation surgery or the reopening surgery (second surgical stage).

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#### Indications for Use for Helix Short Cover Screw:

This product is used for the maintenance of soft tissue, during the bone integration stage of Neodent implants to be rehabilitated with the late loading technique. The Cover Screw must remain intragingival, preventing the growth of tissue over the implant platform. The seating of the Cover Screw takes place in the conical region of the implant interface.

### Indications for Use for Temporary Abutment for Helix Short Implant

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. Temporary Abutments are indicated to be installed over Helix Short Implants and to provide support for prosthetic structures for up to 6 months.

#### Indications for Use for Helix Short Titanium Base:

The Helix Short Implant Titanium Base is a titanium base that is placed over Neodent dental implants to provide support for customized prosthetic restorations, such as copings and crowns. It is indicated for single- and multiple-structure restorations, screw- or cementretained on implants installed in the maxilla or mandible. All digitally-designed copings and/or crowns to be used with the Neodent Titanium Base System must be sent to Straumann for manufacture at a validated milling center.

#### SUBJECT DEVICE DESCRIPTIONS

- . All the subject devices are intended for single use;
- The subject implants are provided sterile via gamma irradiation and the subject abutments are provided sterile via Ethylene Oxide to an SAL of 1x10-9;
- . The subject implants are manufactured of Commercially Pure Titanium (Grade 4), the subject abutments, prosthetic screws and abutment screws are manufactured of Titanium alloy Ti-6Al-4V ELI (ASTM F136) and the restorations placed onto Helix Short Titanium Bases are made of various top half materials.
- . The subject implants have a wide cone prosthetic interface with an internal hexagon for short implants lengths available from 4.0 to 7.0; cylindrical shape with double threads and conical apex with three helical flutes for diameters from 3.75 to 7.0mm.
- . The implants are provided in two different surfaces: Neoporos: Sand blasted and acid etched, and Acqua: Hydrophilic surface aggregated to the rough surface obtained by double treatment: abrasive blasting and acid subtraction.
- The Helix Short Implant Titanium Base abutments is used as two-piece abutment, where the base is premanufactured from titanium alloy and the top half is created via burn out coping or a digital workflow with CAD/CAM at a validated milling center. The final top half can be created from Ticon, Coron, Zerion LT, IPS e.max, or PMMA. The top half and base pieces are cemented together to form the final abutment.

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The various materials that can be used to create top halves for titanium bases and cements were already evaluated and cleared by FDA. Please find below a table with all clearance information for these materials:

| Material | Raw material | 510(k) of the material |
|--------------------------|-------------------------|-------------------------------------------------------------------------------|
| Ticon | Titanium | Exempt according to CFR<br>872.3710 (subpart E): Dental Base<br>Metal Alloys. |
| Coron | CoCr alloy | |
| Zerion LT | Zirconia | K061804 |
| IPS e.max | Lithium Dissilicate | K132209 |
| Polycon ae | PMMA | K071548 |
| Panavia-Kuraray cement | Chemically-active resin | K183537 |
| Ivoclar Multilink cement | Lithium Dissilicate | K130436 |

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#### TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE

#### Table 1 - Technological Characteristic Comparison Table – Helix Short Implants

| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Neodent Implant System - Helix<br>Short Implant System<br>JJGC Indústria e Comércio de<br>Materiais Dentários S.A. | K163194<br>Neodent Implant System - GM<br>Line<br>JJGC Indústria e Comércio de<br>Materiais Dentários S.A. | K200586<br>Straumann TLX Implant System<br>Institut Straumann AG | K123022<br>Neodent Implant System<br>JJGC Indústria e Comércio de<br>Materiais Dentários S.A. | K202942<br>Straumann® 4 mm Short<br>Implants<br>Straumann USA, LLC | Equivalence<br>Discussion |
| Indications for<br>Use | The Neodent Implant<br>System is recommended<br>for surgical procedures on<br>maxilla or mandible bones.<br>It provides support for<br>prosthetic components<br>such as artificial teeth, thus<br>restoring the chewing<br>function. It may be used<br>with single-stage or two-<br>stage procedures, for<br>single or multiple unit<br>restorations, and may be<br>loaded immediately when<br>good primary stability is<br>achieved and with<br>appropriate occlusal<br>loading. | The Neodent Implant System<br>is intended to be surgically<br>placed in the bone of the<br>upper or lower jaw to<br>provide support for<br>prosthetic devices such as<br>artificial teeth, to restore<br>chewing function. It may be<br>used with single-stage or<br>two-stage procedures, for<br>single or multiple unit<br>restorations, and may be<br>loaded immediately when<br>good primary stability is<br>achieved and with<br>appropriate occlusal loading. | Straumann TLX Implants are<br>suitable for endosteal<br>implantation in the upper and<br>lower jaws and for the<br>functional and esthetic oral<br>rehabilitation of edentulous<br>and partially edentulous<br>patients. TLX Implants can be<br>placed with immediate<br>function on single-tooth and<br>multiunit restorations when<br>good primary stability is<br>achieved and with appropriate<br>occlusal loading to restore<br>chewing function. The<br>prosthetic restorations are<br>connected to the implants<br>through the corresponding<br>abutment components. | | | Equivalent<br>Although the<br>language is slightly<br>different, the<br>indications for use<br>of the subject<br>devices is the same<br>as the primary<br>predicate device<br>(K163194) and<br>equivalent to the<br>indications for use<br>of reference<br>predicate device<br>(K200586). The<br>subject and<br>predicate devices<br>are intended to be<br>surgically placed in<br>the bone of the<br>upper or lower jaw<br>to provide support<br>for prosthetic<br>devices such as<br>artificial teeth, to<br>restore chewing<br>function. |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | |
| | Neodent Implant System - Helix<br>Short Implant System<br>JJGC Indústria e Comércio de<br>Materiais Dentários S.A. | K163194<br>Neodent Implant System – GM<br>Line<br>JJGC Indústria e Comércio de<br>Materiais Dentários S.A. | K200586<br>Straumann TLX Implant System<br>Institut Straumann AG | K123022<br>Neodent Implant System<br>JJGC Indústria e Comércio de<br>Materiais Dentários S.A. | K202942<br>Straumann® 4 mm Short<br>Implants<br>Straumann USA, LLC | Equivalence<br>Discussion |
| Implant-<br>Abutment<br>interface | Internal Hex | Morse taper | TorcFit (with conical fitting) | Morse taper | Internal octagon | Equivalent<br>The subject and<br>predicate devices<br>have internal<br>implant to<br>abutment<br>connection. |
| Design | Cylindrical body<br>Tissue level | Conical body (Helix)<br>Bone level | Tapered body<br>Tissue level | Cylindrical body<br>Bone level | Cylindrical body<br>Tissue level | Identical<br>Cylindrical shape and<br>tissue level as the<br>reference devices. |
| Reusable | No | No | No | No | No | Identical<br>The subject<br>devices and the<br>predicate devices<br>are indicated for<br>single use. |
| Length (mm) | 4.0 / 5.5 / 7.0 / 8.5 | 8 / 10 / 11.5 / 13 / 16 / 18<br>(GM Helix) | 6.0 / 8.0 / 10 / 12 / 14 / 16 / 18 | - 5.0 / 6.0 (WS) | 4.0 | Equivalent<br>Subject implant<br>lengths are within<br>the range of the<br>predicate devices. |
| Collar length<br>(mm) | 1.8 | N/A | 1.8 | N/A | 1.8 | Identical<br>Subject implant and<br>reference devices with<br>tissue level have a<br>collar neck of 1.8mm. |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | |
| | Neodent Implant System - Helix<br>Short Implant System<br>JJGC Indústria e Comércio de<br>Materiais Dentários S.A. | K163194<br>Neodent Implant System – GM<br>Line<br>JJGC Indústria e Comércio de<br>Materiais Dentários S.A. | K200586<br>Straumann TLX Implant System<br>Institut Straumann AG | K123022<br>Neodent Implant System<br>JJGC Indústria e Comércio de<br>Materiais Dentários S.A. | K202942<br>Straumann® 4 mm Short<br>Implants<br>Straumann USA, LLC | Equivalence<br>Discussion |
| Diameter (Ø)<br>(mm) | 3.75 / 4.0 / 5.0 / 6.0 / 7.0 | 3.5 / 3.75 / 4.0 / 4.3 / 5.0<br>(GM Helix) | 3.75 / 4.0 / 4.5 / 5.0 / 5.5 / 6.5 | 4.0 / 5.0 / 6.0 (WS) | 4.1 / 4.8 | Equivalent<br>Subject device<br>diameters are<br>within the range of<br>diameters of the<br>predicates devices<br>or larger (Ø 7.0).<br>Larger diameters<br>do not represent a<br>worst case in<br>terms of<br>performance. |
| Material | Commercially pure<br>Titanium grade 4 (ASTM<br>F67) | Commercially pure Titanium<br>grade 4 (ASTM F67) | Titanium-13 Zirconium alloy | Commercially pure titanium<br>grade 4 (ASTM F67) | Titanium-13 Zirconium<br>alloy | Identical<br>Identical to the<br>primary predicate<br>device and the<br>Neodent reference<br>devices (K123022) |
| Sterilization<br>Method | Gamma irradiation to an<br>SAL of 1x10-6 | Gamma irradiation to an SAL of<br>1x10-6 | Gamma irradiation to an SAL of<br>1×10-6 | Gamma irradiation to an SAL of<br>1×10-6 | Gamma irradiation to an SAL<br>of 1x10-6 | Identical<br>Subject<br>devices<br>and<br>predicate<br>devices<br>are<br>provided sterile by<br>the<br>same<br>sterilization<br>method. |
| Surface<br>treatment | NeoPoros<br>Acqua | Neoporos<br>Acqua | SLActive® | NeoPoros | SLActive® | Identical<br>Identical<br>to the<br>primary<br>predicate<br>device. |

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| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Neodent Implant System - Helix Short<br>Implants 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<br>Materiais Dentários S.A | K203309<br>NUVO CF Implant System<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | Equivalence<br>Discussion |
| Indications for Use | Mini Straight and Angled Abutment:<br>The Neodent Implant System is<br>recommended for surgical procedures<br>on maxilla or mandible bones. It<br>provides support for<br>prosthetic<br>components such as artificial teeth,<br>thus restoring the chewing function. It<br>may be used in one- or two-stage<br>procedures, multiple restorations, as<br>well as immediate loading when there<br>is good primary stability and adequate<br>occlusal load. Multiple rehabilitations<br>may be splinted rigidly. | GM Mini Conical and GM Exact Mini<br>Conical Abutments:<br>The Neodent Implant System is<br>intended to be surgically placed in the<br>bone of the upper or lower jaw to<br>provide support for prosthetic devices<br>such as artificial teeth, to restore<br>chewing function. It may be used with<br>single stage or two-stage procedures<br>for single or multiple unit restorations<br>and may be loaded immediately when<br>good primary stability is achieved and<br>with appropriate occlusal loading. | Multi-Unit Screw Retained Abutment<br>CF (Straight/Angled):<br>The Implant System is intended to be<br>surgically placed in the maxilla or<br>mandible to provide support for<br>prosthetic devices such as artificial<br>teeth in order to restore chewing<br>function. It may be used with single-<br>stage or two-stage procedures, for<br>single or multiple unit restorations,<br>and may be loaded immediately when<br>good primary stability is achieved and<br>with appropriate occlusal loading.<br>Multiple tooth applications may be<br>rigidly splinted. | Equivalent<br>Although the<br>language is slightly<br>different, the indications for use of the<br>subject devices is included into the<br>indications of the predicate devices. The<br>subject and predicate device intended to<br>be surgically placed in the bone of the<br>upper or lower jaw to provide support<br>for prosthetic devices such as artificial<br>teeth, to restore chewing function. It<br>may be used with single stage or two-<br>stage procedures, for single or multiple<br>unit restorations, and may be loaded<br>immediately when good primary stability<br>is achieved and with appropriate occlusal<br>loading. |
| Abutment Design | Surface:<br>Machined<br>with<br>pink<br>electrolysis<br>Mini Straight Abutment:<br>Gingival height: 0.2, 1.5, 2.5, 3.5, 4.5<br>Mini angled abutment:<br>Gingival height: 0.6, 1.5, 2.5, 3.5<br>Angulation: 17° | Surface: Machined<br>GM Mini Conical Abutments:<br>Gingival height: 0.8; 1.5, 2.5, 3.5, 4.5,<br>5.5<br>GM Exact Mini Conical Abutments:<br>Gingival height: 1.5, 2.5, 3.5<br>Angulation: 17° and 30° | Surface: Machined and electrolysis<br>Straight Abutment:<br>Gingival height: 1.0, 2.0, 3.0, 4.0 and 5.0<br>mm;<br>Angled Abutment:<br>Gingival height: 2.0 and 3.0 mm<br>Angulation: 17° and 30° | Equivalent<br>The subject device have the same surface of<br>reference predicate device and similar<br>geometry and range of dimensions and<br>angulation of primary predicate device. |
| Single Use | Yes | Yes | Yes | Identical<br>The subject devices and predicates<br>devices are indicated for single use. |

#### Table 2 - Technological Characteristic Comparison Table – Mini Abutments

JJGC Indústria e Comércio de Materiais Dentários S.A.

{12}------------------------------------------------

K223638 - Neodent Implant System – Helix Short Implant System

| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | |
|-------------------------|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Neodent Implant System - Helix Short<br>Implants 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<br>Materiais Dentários S.A | K203309<br>NUVO CF Implant System<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | Equivalence<br>Discussion |
| Raw material | Titanium alloy ASTM F136. | Titanium alloy ASTM F136. | Titanium alloy ASTM F136. | Identical<br>The subject devices and predicates<br>devices are manufactured of the same<br>raw material. |
| Sterilization<br>Method | Provided sterile via Ethylene Oxide<br>to an SAL of 10-6 | Provided sterile via Ethylene Oxide to<br>an SAL of 10-6 | Provided sterile via Ethylene Oxide to an<br>SAL of 10-6 | Identical<br>The subject devices and the primary<br>predicate devices are provided in sterile<br>condition to an SAL of 1 x 10-6 by the same<br>sterilization method. |

#### Table 3 - Technological Characteristic Comparison Table – Attachments

| | SUBJECT DEVICE | REFERENCE DEVICE | |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Neodent Implant System - Helix Short Implants<br>System<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | K220251<br>Neodent Implant System - Narrow Implant System<br>JJGC Indústria e Comércio de Materiais Dentários<br>S.A | Equivalence<br>Discussion |
| Indications for Use | Helix Short Attachment:<br>The Neodent Implant System is<br>recommended for surgical procedures on<br>maxilla or mandible bones. It provides<br>support for prosthetic components such as<br>artificial teeth, thus restoring the chewing<br>function. It may be used in one- or two-stage<br>procedures, multiple unit restorations, as<br>well as immediate loading when there is<br>primary stability and adequate occlusal load. | NGM Attachments<br>The Neodent Implant System is intended to be<br>surgically placed in the bone of the upper or lower<br>jaw to provide support for prosthetic devices, such<br>as artificial teeth, to restore chewing function. It may<br>be used with single stage or two-stage procedures<br>for single or multiple unit restorations, and may be<br>loaded immediately when good primary stability is<br>achieved and with appropriate occlusal loading. | Equivalent<br>Although the language is slightly different, the indications<br>for use of the subject device…