Neodent Implant System - Mini Abutment 60°

K203542 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · NHA · Aug 2, 2021 · Dental

Device Facts

• Record ID: K203542
• Device Name: Neodent Implant System - Mini Abutment 60°
• Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
• Product Code: NHA · Dental
• Decision Date: Aug 2, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mini Conical Abutments are indicated for use with Zygomatic Implants, in cases of severe jaw resorption, in order to restore patient aesthetics and chewing function. It may be used with single-stage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Device Story

Neodent Implant System - Mini Abutment 60° is a dental abutment used in conjunction with Zygomatic Implants. Manufactured from titanium alloy (Ti6Al4V-ELI), the device features an anti-rotational implant-to-abutment interface compatible with GM Zygomatic Implants. It is screw-retained to the implant and supports multi-unit restorations. Used in clinical dental settings by trained professionals, the abutment serves as a connector between the zygomatic implant and the prosthetic restoration. By providing a stable interface, it enables the restoration of aesthetics and chewing function in patients with severe jaw resorption. The device is provided sterile for single use.

Clinical Evidence

Bench testing only. Evidence includes dynamic fatigue testing per ISO 14801, static torsional loading, sterilization validation (ISO 11135), ethylene oxide residual assessment (ISO 10993-7), biocompatibility (ISO 10993-5, ISO 10993-18), and shelf-life validation (ASTM F1980). No clinical data provided.

Technological Characteristics

Material: Titanium alloy (Ti6Al4V-ELI) per ASTM F136. Design: 60° angulation, various gingival heights, screw-retained, anti-rotational GM interface. Sterilization: Ethylene oxide (SAL 1x10^-6). Single-use. Compatible with Neodent GM Line impression copings, provisional cylinders, and protective cylinders.

Indications for Use

Indicated for patients with severe jaw resorption requiring Zygomatic Implants to restore aesthetics and chewing function. Suitable for single-stage procedures and multiple unit restorations; allows immediate loading given good primary stability and appropriate occlusal loading.

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

• Neodent Implant System - Zygomatic Implants and Abutments (K190718)

Reference Devices

• NobelZygoma 0° (K161598)
• MRI Safety Information Labeling Change (K182620)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

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: K203542

Trade/Device Name: Neodent Implant System - Mini Abutment 60° Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: July 2, 2021 Received: July 8, 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 (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 Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K203542

Device Name Neodent Implant System - Mini Abutment 60°

#### Indications for Use (Describe)

The Mini Conical Abutments are indicated for use with Zygomatic Implants, in cases of severe jaw resorption, in order to restore patient aesthetics and chewing function. It may be used with single-stage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

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

| <b> <span style="font-size: 10pt"> <span style="text-decoration: overline">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </b> | <span style="font-size: 10pt"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|

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# 510(k) Summary K203542

ADMINISTRATIVE INFORMATION

| Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA<br>(dba Neodent) |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| | Av. Juscelino Kubitschek de Oliveira, 3291 |
| | Curitiba, Parana, Brazil 81270-200 |
| | Registration No.: 3008261720 |
| | Owner/Operator No.: 10031702 |
| Contact Person | Jennifer M. Jackson, MS |
| | Director of Regulatory Affairs, |
| | Straumann USA |
| | E-mail: [e-mail] |
| | Telephone [phone] |
| Date Prepared | 29/Jul/2021 |
| Preparer / Alternate Contact | Mariana Soares Hartmann |
| | Regulatory Affairs Analyst |
| | JJGC Indústria e Comércio de Materiais Dentários SA |
| | E-mail: [e-mail] |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/ Proprietary Name | Neodent Implant System - Mini Abutment 60° |
| Common Name | Endosseous dental implant |
| Classification Name(s) | Endosseous dental implant Abutment |
| Classification Regulation(s) | 21 CFR 872.3630, Class II |
| Product Code(s) | NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
| PREDICATE DEVICE INFORMATION | |
| Primary Predicate Device | K190718 - Neodent Implant System - Zygomatic Implants and<br>Abutments, JJGC Indústria e Comércio de Materiais Dentários SA |

JJGC Indústria e Comércio de Materiais Dentários S.A.

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K161598 - NobelZygoma 0°, Nobel Biocare AB Reference Predicate Devices K182620 - MRI Safety Information Labeling Change, JJGC Indústria e Comércio de Materiais Dentários SA

#### INDICATIONS FOR USE

The Mini Conical Abutments are indicated for use with Zygomatic Implants, in cases of severe jaw resorption, in order to restore patient aesthetics and chewing function. It may be used with single-stage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

#### SUBJECT DEVICE DESCRIPTION

#### Mini Abutments 60°

- Intended for single use;
- Provided sterile via ethylene oxide gas;
- Manufactured of titanium alloy (Ti6Al4V-ELI) per ASTM F136;
- Available in different gingival heights;
- Screw-retained to the implant;
- Provided with an anti-rotational implant-to-abutment interface compatible with GM Zygomatic Implants;
- Provided with coronal geometries in rotational (non-indexed) versions to support multi-unit restorations
- . The subject devices are compatible with Impression copings, Provisional cylinders, Protective cylinders and Copings of the Neodent GM Line previously cleared per market.

### TECHNOLOGICAL CHARACTERISTIC COMPARISON

The Substantial Equivalence Comparison table is provided on the pages that follow below.

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| | SUBJECT DEVICES | PRIMARY PREDICATE | REFERENCE PREDICATE | |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| COMPARISON | Subject<br>Mini Abutments 60°<br>JJGC Indústria e Comércio de Materiais Dentários<br>S.A. | K190718<br>Neodent Implant System - Zygomatic Implants and<br>Abutments<br>JJGC Indústria e Comércio de Materiais Dentários S.A. | K161598<br>NobelZygoma 0°<br>Nobel Biocare AB | EQUIVALENCE DISCUSSION |
| Indications for Use | The Mini Conical Abutments are indicated for<br>use with Zygomatic Implants, in cases of severe<br>jaw resorption, in order to restore patient<br>aesthetics and chewing function. It may be<br>used with single-stage or two-stage<br>procedures, for multiple unit restorations, and<br>may be loaded immediately when good<br>primary stability is achieved and with<br>appropriate occlusal loading. | Zygomatic Implants are indicated for surgical<br>installation in the zygoma region, in cases of severe<br>jaw resorption, in order to restore patient esthetics<br>and chewing function. Zygomatic Implants are<br>recommended for the posterior (pre-molar/molar)<br>region, one implant on each side, with at least two<br>standard dental implants in the anterior region to<br>support a fixed restoration. Zygomatic Implants may<br>be loaded immediately when good primary stability<br>is achieved and with appropriate occlusal loading. | NobelZygoma implants are end<br>osseous dental implants intended<br>to be surgically placed in the bone<br>of the upper jaw arch to provide<br>support for prosthetic devices,<br>such as artificial teeth, in order to<br>restore patient esthetics and<br>chewing function. The<br>NobelZygoma Implants are<br>appropriate for immediate loading<br>when good primary stability is<br>achieved and with appropriate<br>occlusal loading. | Equivalent<br>Subject and primary<br>predicate devices are<br>indicated to be used<br>together. The wording of the<br>subject devices is a slightly<br>different from the one of the<br>primary predicate because<br>the current submission is<br>regarding abutments only<br>and the predicate devices<br>contained also implants in<br>the submission. |
| Implant-to-Abutment<br>Interface | GM | GM | GM | Identical<br>The implant-to abutment<br>interface is equivalent to that<br>of the primary predicate<br>device. |
| Abutment Design | Gingival Height: 1.5; 2.5 mm<br>Angulation: 60° | Gingival Height: 1.5; 2.5 mm<br>Angulation: 45° | Gingival Height: 6; 8 mm<br>Angulation: 45° and 60° | Equivalent<br>The subject device gingival<br>heights are equivalent to the<br>primary predicate devices<br>and the angulation is<br>equivalent to the reference<br>devices. Dynamic fatigue<br>testing of the subject devices<br>indicates performance<br>suitable for the intended use. |
| Material | Titanium alloy (Ti6Al4V-ELI) per ASTM F136 | Titanium alloy (Ti6Al4V-ELI) per ASTM F136 | Titanium alloy (Ti6Al4V-ELI) per ASTM<br>F136 | Identical<br>Subject and predicate devices<br>have the same material of<br>construction. |

JJGC Indústria e Comércio de Materiais Dentários S.A.

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| | SUBJECT DEVICES | PRIMARY PREDICATE | REFERENCE PREDICATE | |
|----------------------|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| COMPARISON | Subject<br>Mini Abutments 60°<br>JJGC Indústria e Comércio de Materiais Dentários<br>S.A. | K190718<br>Neodent Implant System - Zygomatic Implants and<br>Abutments<br>JJGC Indústria e Comércio de Materiais Dentários S.A. | K161598<br>NobelZygoma 0°<br>Nobel Biocare AB | EQUIVALENCE DISCUSSION |
| Single Use | Yes | Yes | Yes | Identical<br>Subject and predicate devices<br>are not reusable. |
| Sterilization Method | Ethylene Oxide to a SAL of 1x10-6 | Ethylene Oxide to a SAL of 1x10-6 | Gamma radiation | Identical<br>Subject and primary predicate<br>devices utilize the same<br>sterilization method and<br>minimum SAL. |
| Compatible devices | GM Line Impression copings, Provisional cylinders,<br>Protective cylinders and Copings already cleared<br>per market. | GM Line Impression copings, Provisional cylinders,<br>Protective cylinders and Copings already cleared per<br>market. | | Identical<br>Subject and primary predicate<br>devices are compatible with the<br>same devices. |

The subject devices have been assessed to deternine whether the previously conducted studies of the MR compatibility of the devices of the Neodent Implant System also apply to the subject devices. It has been determined that the subject devices do not result in new worst-asse constructs for the purpose of assessing MR compatibility. The subject devices and a patient treated with the subject devices can be safely scanned observing the parameters previously established per K182620.

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## SUMMARY OF NON-CLINICAL PERFORMANCE DATA

Comparative dynamic fatigue test per ISO 14801 and FDA guidance was performed following the Zygomatic surgical protocol to determine the fatigue strength using the subject devices as compared to similar constructs of the reference devices.

Torsion testing was performed to evaluate the subject device's screws under static torsional loading. The results met the acceptance criteria.

Sterilization of the subject abutments via ethylene oxide gas was validated per ISO 11135. A minimum Sterility Assurance Level (SAL) of 1 x 10-6 has been validated.

Ethylene oxide residuals have been assessed per ISO 10993-7. Residuals are within accepted limits.

Biological Safety Assessment guided by ISO 10993-1 and FDA guidance. Reference to previous biocompatibility testing is supplied as follows:

- -Cytotoxicity testing was performed per ISO 10993-5.
- -Chemical characterization was performed per ISO 10993-18.

Product and package stability has been validated per ASTM F1980. The subject device's shelflife was determined to be 5 years.

The MR Conditional Labeling was leveraged from K182620.

### CONCLUSION

The conclusions drawn from the nonclinical tests demonstrate that the subject devices are substantially equivalent to the legally marketed predicate devices.