Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a mechanical dental abutment and its associated testing, with no mention of software, algorithms, or AI/ML capabilities.

Therapeutic

Yes
The device is an abutment for Zygomatic Implants, used to restore patient aesthetics and chewing function in cases of severe jaw resorption, directly addressing a health condition.

Diagnostic

No

The device description indicates it is a "Mini Conical Abutment" used with Zygomatic Implants to restore patient aesthetics and chewing function, functioning as a structural component rather than a tool for diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is manufactured of titanium alloy and is a physical implant component (abutment). The performance studies also focus on physical properties like fatigue strength and torsion.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to restore patient aesthetics and chewing function by being used with Zygomatic Implants in cases of severe jaw resorption. This is a therapeutic and restorative purpose, not a diagnostic one.
Device Description: The device is a physical implant component (abutment) made of titanium alloy. It's designed to be surgically implanted and support dental restorations. This is characteristic of a medical device used for treatment, not for analyzing samples from the body to diagnose a condition.
Lack of Diagnostic Elements: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
Performance Studies: The performance studies focus on mechanical properties (fatigue, torsion), sterilization, biocompatibility, and stability – all relevant to a surgically implanted medical device, not an IVD.

In summary, the Mini Conical Abutments are a medical device used for dental restoration, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

NHA

Device Description

Minconical Abutments 60 are:

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

zygoma region, upper jaw arch

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K190718 - Neodent Implant System - Zygomatic Implants and Abutments, JJGC Indústria e Comércio de Materiais Dentários SA

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
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.(b)
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.)

Summary

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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.

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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 K203542

ADMINISTRATIVE INFORMATION

| Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA
(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: jennifer.jackson@straumann.com |
| | Telephone (978) 747-2509 |
| Date Prepared | 29/Jul/2021 |
| Preparer / Alternate Contact | Mariana Soares Hartmann |
| | Regulatory Affairs Analyst |
| | JJGC Indústria e Comércio de Materiais Dentários SA |
| | E-mail: mariana.hartmann@neodent.com |
| 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
Abutments, JJGC Indústria e Comércio de Materiais Dentários SA |

JJGC Indústria e Comércio de Materiais Dentários S.A.

4

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

JJGC Indústria e Comércio de Materiais Dentários S.A.

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