Neodent Implant System - CM Pro PEEK Abutment

K170080 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · NHA · Nov 2, 2017 · Dental

Device Facts

• Record ID: K170080
• Device Name: Neodent Implant System - CM Pro PEEK Abutment
• Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
• Product Code: NHA · Dental
• Decision Date: Nov 2, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The Pro PEEK Abutments are indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months. They can be used in one or two stage procedures and also immediate load when there is good primary stability.

Device Story

Neodent Implant System - CM Pro PEEK Abutments are temporary prosthetic components; installed onto CM dental implants to support provisional prostheses for up to 6 months. Device consists of customizable PEEK cylindrical body and titanium alloy base with Morse taper connection; includes coupled screw for fixation. Used by dentists in clinical/surgical settings; customization performed chairside using hand-milling tools under aseptic conditions. Device maintains/shapes soft tissue during healing phase. Benefits include temporary stabilization of prosthesis and soft tissue management prior to final restoration. No CAD/CAM or automated design allowed.

Clinical Evidence

No clinical data submitted. Substantial equivalence supported by bench testing: biocompatibility (ISO 10993-1, -5, -18), dynamic fatigue testing (ISO 14801), and sterilization validation (ISO 11135, ISO 10993-7). Shelf life validated via accelerated aging (ASTM F1980).

Technological Characteristics

Materials: PEEK (customizable body) and Titanium alloy Ti-6Al-4V ELI (implant-to-abutment interface). Connection: 11.5° Morse taper with hexagonal indexing. Dimensions: 4.5mm and 6.0mm diameters; 0.8mm to 5.5mm lengths. Sterilization: Ethylene Oxide (EO). Connectivity: None (mechanical).

Indications for Use

Indicated for patients requiring temporary support for dental prosthesis structures (single or multiple units) on Neodent implants for up to 6 months. Suitable for one or two-stage procedures and immediate loading when good primary stability is achieved.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). 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.)

Predicate Devices

• Straumann RC Temporary Abutments (K093027)

Reference Devices

• Neodent Implant System (K101945)
• Neodent Implant System (K133510)

Submission Summary (Full Text)

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JJGC Industria e Comercio de Materiais Dentarios SA % Jennifer Jackson Senior Manager, Regulatory Affairs & Quality Management Straumann USA, LLC 60-100 Minuteman Rd Andover, Massachusetts 01810

November 2, 2017

Re: K170080

Trade/Device Name: Neodent Implant System - CM Pro PEEK Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 25, 2017 Received: September 26, 2017

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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Mary S. Runner -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation 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)

K170080

Device Name

Neodent Implant System - CM Pro PEEK Abutments

Indications for Use (Describe)

The Pro PEEK Abutments are indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months. They can be used in one or two stage procedures and also immediate load when there is good primary stability.

| Type of Use (Select one or both, as applicable) | <span> <span style="padding-right: 5px;"> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="padding-right: 5px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |
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### 510(k) Summary

| Submitter | Straumann USA, LLC<br>60 Minuteman Road<br>Andover, MA 01810<br>Registration No.: 1222315<br>Owner/Operator No.: 9005052 | | | | |
|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| | on behalf of: | | | | |
| | JJGC Indústria e Comércio de Materiais Dentários SA<br>Av. Juscelino Kubitschek de Olivera, 3291<br>Curtiba, Parana, BRAZIL 81270-200<br>Registration No.: 3008261720<br>Owner/Operator No.: 10031702 | | | | |
| Contact Person | Jennifer M. Jackson, MS<br>Director, Regulatory Affairs & Quality, Straumann USA<br>E-Mail: [e-mail]<br>Telephone [phone] | | | | |
| Date Prepared | 02/November/2017 | | | | |
| Prepared by | Ana Carolina Martins Vianna<br>RA & Compliance Manager, Institut Straumann AG<br>[e-mail] | | | | |
| Product Code<br>Device Class<br>Classification Panel<br>Classification Name<br>Common Name<br>Proprietary name | NHA (21 CFR 872.3630)<br>II<br>Dental<br>Endosseous dental implant abutment (21 CFR 872.3630)<br>Endosseous dental implant abutment<br>Neodent Implant System - CM Pro PEEK Abutments | | | | |
| Primary Predicate<br>Devices<br>Reference Devices | K093027 - Straumann RC Temporary Abutments, Institut<br>Straumann AG<br>K101945 - Neodent Implant System, JJGC Indústria e Comércio de<br>Materiais Dentários SA<br>K133510 - Neodent Implant System, JJGC Indústria e Comércio de<br>Materiais Dentários SA | | | | |

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#### 5.1 Device Description

CM Pro PEEK abutments are temporary intermediary prosthetic components to be installed onto CM Implants to support the provisional prosthesis up to 6 months. They are composed of a customizable cylindrical body with an internal channel for the screw access and of a base for anti-rotational implant connection. The customizable portion is manufactured in PEEK (high performance polymer – specific for dental use) and the implant-to-abutment interface is made of titanium alloy. They have a coupled screw for fixing them to the Implant.

They present a hexagonal indexing at the apical end of the Morse taper connection to provide anti-rotational feature to the implant-to-abutment connection, and facilitates proper alignment of the prosthesis to the implant.

They are available in diameters of 4.5 and 6.0 mm and in lengths of 0.8, 1.5, 2.5, 3.5, 4.5 and 5.5 mm.

Image /page/4/Picture/6 description: The image shows a dental implant abutment. The abutment is made of two parts: a white ceramic or composite material on top and a silver-colored metal base. The metal base has a threaded screw at the bottom for attachment to the implant fixture in the jawbone. The abutment is designed to connect the implant to a dental crown or other restoration.

Figure 1: Model of CM Pro PEEK abutment

The customization of the PEEK chimney must be done into the mouth of patient or chairside. Chairside customization means that the device preparation must be done in a controlled environment in the operating room, in the context of the prosthetic placement, in a surgical site's aseptic environment using sterilized tools. The dentist can wear the PEEK chimney with the aid of suitable techniques, high speed handpiece and cooling, according to the patient interocclusal space, respecting the minimum of 5mm of height. No customization is allowed for the diameter/ wall thickness of the abutment, as well as no angulation. No CAD/CAM design and fabrication is allowed for the CM Pro PEEK Abutments. Only hand-milling may be used for abutment modification.

The CM Pro PEEK abutments can be used before the installation of the final prosthesis to maintain, stabilize and shape the soft tissue (gum) during the healing phase.

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#### 5.2 Indications for Use

The Pro PEEK Abutments are indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months. They can be used in one or two stage procedures and also immediate load when there is good primary stability.

#### 5.3 Technological Characteristics

The temporary abutments made of PEEK are designed to be substantially equivalent to the predicate devices previously cleared per K093027.

The subject and predicate devices are based on the following same technological elements:

- Endosseous dental abutments to provide support for temporary restorations (primary predicate device);
- -Possibility of use in single or two-stage procedures, for single or multiple-unit restorations (reference devices);
- -Same sterilization methods and packaging (reference devices).

The following technological differences exist between the subject and predicate devices:

- Design of Morse taper implant-to-abutment interfaces; -
- -The subject abutment is provided sterile by EO exposition whereas its primary predicate device is provided non-sterile for end-user sterilization.

In the end of this Section, a comparison between the features of subject device and its predicate devices is shown in a tabular format. The assessment of the differences is also included.

#### 5.4 Performance data

The following performance data supports the substantial equivalence determination:

### Biocompatibility testing

The raw material PEEK used in fabrication of the CM Pro PEEK Abutments is the same of that cleared for the predicate device under K093027. Any difference in the biocompatibility posed by differences in the manufacturing process has been addressed by chemical characterization and cytotoxicity assessments. No extracts of leachable substances of concern were identified and no cytotoxicity response was observed.

The Biological Assessment has been performed according to ISO 10993-1 Biological evaluation of medical devices. Evaluation and testing, ISO 10993-5 Biological evaluation of medical devices. Tests for in vitro cytotoxicity and ISO 10993-18 Biological evaluation of medical devices. Chemical characterization of materials.

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### Mechanical testing

The strength of the CM Pro PEEK Abutment is demonstrated through fatigue testing performed according to ISO 14801 - Dentistry - Implants - Dynamic fatigue test for endosseous dental implants and FDA document Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.

### Sterilization validation

The subject abutments are sterilized by exposure to ethylene oxide (EO). Sterilization has been validated by the bioburden method, according to ISO 11135 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation, and routine control of a sterilization process for medical devices. EO sterilization residuals have been verified to be less than the maximum allowable limits as defined in ISO 10993-7 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals. All methods achieve a Sterility Assurance Level (SAL) of 10-6.

The subject devices are not represented to be non-pyrogenic.

Shelf life was determined through both real time and accelerated aging protocol, according to ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. After aging, samples were submitted to sterility test, thermal seal integrity test and tensile strength of thermal seal according to ISO 11737 - Sterilization of medical devices -Microbiological methods - Part 2: Tests of sterility Performed in the definition, validation and maintenance of a sterilization process and US Pharmacopeia; ASTM E499/E499M Standard Practice for Leaks Using the Mass Spectrometer Leak Detector in the Detector Probe Mode, ASTM F1929 Standard Test Method for detecting Seal Leaks in Porous Medical Packaging by Dye Penetration and ASTM F88/F88M Standard Test Method for Seal Strength of Flexible Barrier Materials.

The sterile barrier shelf life for the subject devices is 2 years.

#### Clinical data

No clinical data has been submitted, referenced, or relied upon to demonstrate substantial equivalence.

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### Table 1: Comparison between the subject and predicate devices.

| | SUBJECT DEVICES | PRIMARY PREDICATE<br>DEVICES | REFERENCE DEVICES | | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Neodent Implant System -<br>CM Pro PEEK Abutment | Straumann RC Temporary<br>Abutment (K093027) | Neodent Implant System<br>(K101945) | Neodent Implant System<br>(K133510) | EQUIVALENCE DISCUSSION |
| Indications for<br>Use | The Pro PEEK Abutments are<br>indicated to be used on<br>Neodent implants to provide<br>temporary support for<br>prosthesis structure for up<br>to 6 months. They can be<br>used in one or two stage<br>procedures and also<br>immediate load when there<br>is good primary stability. | The Straumann RC<br>Temporary Abutments are<br>indicated for use in<br>Straumann RC Bone Level<br>Implants for temporary<br>restorations of single crowns<br>and bridges for up to six<br>months | The Neodent Implant<br>System is intended to be<br>surgically placed in the<br>bone of the upper or lower<br>jaw to 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<br>loading. Multiple tooth<br>applications may be rigidly<br>splinted. | The Neodent Implant<br>System is intended to be<br>surgically placed in the<br>bone of the upper or lower<br>jaw to 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<br>loading. Multiple tooth<br>applications may be rigidly<br>splinted | Equivalent<br>The Indications for Use for<br>the subject and primary<br>predicate devices are similar<br>with the exception of minor<br>wording differences.<br>The intention to provide<br>support to temporary<br>restorations is the same.<br>The subject device<br>Indications for Use<br>references the term<br>"prosthesis structure" which<br>is an overarching term that<br>encompasses both crowns<br>and bridges.<br>The specific indication for<br>immediate load when there<br>is good primary stability is<br>dependent on the implant<br>Indications for Use. The<br>implants also need to be<br>indicated for immediate<br>loading when good primary<br>stability is achieved. |
| | SUBJECT DEVICES | PRIMARY PREDICATE<br>DEVICES | REFERENCE DEVICES | | EQUIVALENCE DISCUSSION |
| | Neodent Implant System –<br>CM Pro PEEK Abutment | Straumann RC Temporary<br>Abutment (K093027) | Neodent Implant System<br>(K101945) | Neodent Implant System<br>(K133510) | |
| Platform<br>Diameter(s) | 4.5 and<br>6 mm | 4.5 mm | NA<br>(only permanent<br>abutments) | 3.3 mm<br>4.1/4.3 mm<br>5.0 mm | Equivalent<br>Subject device diameters are<br>the same of the predicate<br>devices or larger. Larger<br>diameters do not represent a<br>worst case in terms of<br>performance. |
| Material | Titanium alloy Ti-6Al-4V ELI<br>PEEK (polyetheretherketone) | Titanium alloy (Ti-6Al-7Nb,<br>TAN)<br>PEEK (polyetheretherketone) | Titanium Grade 4<br>Titanium alloy Ti-6Al-4V ELI | Titanium alloy Ti-6Al-4V ELI | Equivalent<br>The subject and the<br>predicate devices are made<br>of the same type of raw<br>material; the adequacy of the<br>systems have been<br>demonstrated via dynamic<br>fatigue tests and<br>biocompatibility assessment. |
| Implant-to-<br>Abutment<br>Connection | CM interface; 11.5° Morse<br>taper with anti-rotational<br>features. | Morse taper interface with<br>anti-rotational features | CM interface; 11.5° Morse<br>taper with anti-rotational<br>features. | HE (external hexagon)<br>interface | Equivalent<br>The performance of each<br>interface has been assessed<br>by dynamic fatigue testing. |

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| | SUBJECT DEVICES | PRIMARY PREDICATE<br>DEVICES | REFERENCE DEVICES | | |
|---------------|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Neodent Implant System –<br>CM Pro PEEK Abutment | Straumann RC Temporary<br>Abutment (K093027) | Neodent Implant System<br>(K101945) | Neodent Implant System<br>(K133510) | EQUIVALENCE DISCUSSION |
| Compatibility | Compatible with Neodent<br>CM implants | Compatible with Straumann<br>implants | Compatible with Neodent<br>CM implants | Compatible with Neodent<br>HE implants | Equivalent<br>The interfaces of Neodent<br>and Straumann devices are<br>not interchangeable. Their<br>performances are assessed<br>respecting the fixtures<br>compatibility. |
| Sterility | Delivered sterile by EO<br>exposure. | Delivered non-sterile. To be<br>sterilized by user before<br>placed in patient mouth<br>(moist steam sterilization). | Delivered sterile by EO<br>exposure. | Delivered sterile by gamma<br>irradiation. | Equivalent<br>The sterilization method and<br>posterior handling of the<br>device is the same as the<br>reference devices. |

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#### 5.5 Conclusions

The documentation submitted in this premarket notification demonstrates that the subject devices have comparable features and performance and, therefore, are substantially equivalent to the identified predicate devices.