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 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.

AI/ML Overview

The provided document is a 510(k) Summary for the Neodent Implant System - Mini Abutment 60°. It describes the device, its indications for use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence through non-clinical performance data.

Based on the provided text, there is no information about a clinical study involving human subjects or AI performance. The summary explicitly states "SUMMARY OF NON-CLINICAL PERFORMANCE DATA". Therefore, most of the requested information regarding acceptance criteria, study type, sample sizes, experts, ground truth, and MRMC studies for AI devices is not available in this document.

Here's what can be extracted:

Acceptance Criteria and Reported Device Performance

The document describes non-clinical acceptance criteria related to mechanical properties, sterilization, and biocompatibility.

Acceptance Criteria Category	Specific Test/Evaluation	Acceptance Criteria	Reported Device Performance/Conclusion
Mechanical Properties	Dynamic fatigue test (per ISO 14801 and FDA guidance)	Performance suitable for intended use	Demonstrated performance suitable for intended use
Mechanical Properties	Torsion testing (for screws)	Results met the acceptance criteria	Results met the acceptance criteria
Sterilization	Ethylene Oxide sterilization (per ISO 11135)	Minimum Sterility Assurance Level (SAL) of 1 x 10^-6	Validated to a minimum SAL of 1 x 10^-6
Sterilization	Ethylene oxide residuals (per ISO 10993-7)	Within accepted limits	Residuals are within accepted limits
Biocompatibility	Cytotoxicity testing (per ISO 10993-5)	(Not explicitly stated, but implied positive)	Performed; reference to previous biocompatibility testing
Biocompatibility	Chemical characterization (per ISO 10993-18)	(Not explicitly stated, but implied positive)	Performed; reference to previous biocompatibility testing
Shelf-life	Product and package stability (per ASTM F1980)	(Not explicitly stated, but implied positive)	Determined to be 5 years
MRI Safety	MR Compatibility	No new worst-case constructs, safe scanning	Subject devices do not result in new worst-case constructs for MR compatibility; can be safely scanned observing established parameters

Information not available in the document:

Sample size used for the test set and the data provenance: Not applicable. The document describes non-clinical (laboratory) testing, not a test set of data from clinical subjects.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not relevant to these non-clinical tests.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No MRMC study was done, as this is not an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance was done, as this is not an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as this is not an AI device and no clinical ground truth was established for the non-clinical tests. The "ground truth" for these tests are objective measurements against established standards (e.g., ISO 14801, ISO 11135).
The sample size for the training set: Not applicable, as this is not an AI device.
How the ground truth for the training set was established: Not applicable, as this is not an AI device.

In summary, this document pertains to a traditional medical device (dental abutment) and relies on non-clinical engineering and materials testing to demonstrate substantial equivalence, not AI algorithm performance or clinical trial data.

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.

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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 (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)

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 andAbutments, 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

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	SubjectMini Abutments 60°JJGC Indústria e Comércio de Materiais DentáriosS.A.	K190718Neodent Implant System - Zygomatic Implants andAbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A.	K161598NobelZygoma 0°Nobel Biocare AB	EQUIVALENCE DISCUSSION
Indications for Use	The Mini Conical Abutments are indicated foruse with Zygomatic Implants, in cases of severejaw resorption, in order to restore patientaesthetics and chewing function. It may beused with single-stage or two-stageprocedures, for multiple unit restorations, andmay be loaded immediately when goodprimary stability is achieved and withappropriate occlusal loading.	Zygomatic Implants are indicated for surgicalinstallation in the zygoma region, in cases of severejaw resorption, in order to restore patient estheticsand chewing function. Zygomatic Implants arerecommended for the posterior (pre-molar/molar)region, one implant on each side, with at least twostandard dental implants in the anterior region tosupport a fixed restoration. Zygomatic Implants maybe loaded immediately when good primary stabilityis achieved and with appropriate occlusal loading.	NobelZygoma implants are endosseous dental implants intendedto be surgically placed in the boneof the upper jaw arch to providesupport for prosthetic devices,such as artificial teeth, in order torestore patient esthetics andchewing function. TheNobelZygoma Implants areappropriate for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading.	EquivalentSubject and primarypredicate devices areindicated to be usedtogether. The wording of thesubject devices is a slightlydifferent from the one of theprimary predicate becausethe current submission isregarding abutments onlyand the predicate devicescontained also implants inthe submission.
Implant-to-AbutmentInterface	GM	GM	GM	IdenticalThe implant-to abutmentinterface is equivalent to thatof the primary predicatedevice.
Abutment Design	Gingival Height: 1.5; 2.5 mmAngulation: 60°	Gingival Height: 1.5; 2.5 mmAngulation: 45°	Gingival Height: 6; 8 mmAngulation: 45° and 60°	EquivalentThe subject device gingivalheights are equivalent to theprimary predicate devicesand the angulation isequivalent to the referencedevices. Dynamic fatiguetesting of the subject devicesindicates performancesuitable for the intended use.
Material	Titanium alloy (Ti6Al4V-ELI) per ASTM F136	Titanium alloy (Ti6Al4V-ELI) per ASTM F136	Titanium alloy (Ti6Al4V-ELI) per ASTMF136	IdenticalSubject and predicate deviceshave the same material ofconstruction.

JJGC Indústria e Comércio de Materiais Dentários S.A.

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	SUBJECT DEVICES	PRIMARY PREDICATE	REFERENCE PREDICATE
COMPARISON	SubjectMini Abutments 60°JJGC Indústria e Comércio de Materiais DentáriosS.A.	K190718Neodent Implant System - Zygomatic Implants andAbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A.	K161598NobelZygoma 0°Nobel Biocare AB	EQUIVALENCE DISCUSSION
Single Use	Yes	Yes	Yes	IdenticalSubject and predicate devicesare not reusable.
Sterilization Method	Ethylene Oxide to a SAL of 1x10-6	Ethylene Oxide to a SAL of 1x10-6	Gamma radiation	IdenticalSubject and primary predicatedevices utilize the samesterilization method andminimum SAL.
Compatible devices	GM Line Impression copings, Provisional cylinders,Protective cylinders and Copings already clearedper market.	GM Line Impression copings, Provisional cylinders,Protective cylinders and Copings already cleared permarket.		IdenticalSubject and primary predicatedevices are compatible with thesame 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.

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.)