Neodent prosthetic abutments are indicated to be used on Neodent implants to provide support for prosthetic structures for up to 6 months. They can be used in single- or two-stage procedures and they are intended to be placed out of occlusion.

Device Description

The subject device is a temporary abutment composed of PEEK with a titanium alloy fixation screw. The subject device is compatible with Neodent zirconia implant bodies with Zilock connection platform (K201491).

Intended for single use;
Provided sterile via Ethylene Oxide;
The subject devices are manufactured of PEEK (high performance polymer – specific for dental use) and are provided along with a screw manufactured of titanium alloy according to ASTM F136 standard;
. ZiLock prosthetic interface with internal indexer;
. Cylindrical format with a passing hole to fixate the screw.

AI/ML Overview

I apologize, but the provided text is an FDA 510(k) Pre-market Notification letter and a 510(k) Summary for a dental implant system. It primarily focuses on demonstrating substantial equivalence of a new device (Neodent Implant System - Zirconia Implant System) to existing predicate devices.

This document does NOT contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The document details:

The device's trade name, regulation number, and product code.
Indications for Use.
Comparison of technological characteristics between the subject device and predicate devices (e.g., intended use, design, materials, sterilization).
Bench testing (biocompatibility, MRI compatibility) and sterilization validation, largely leveraged from predicate devices.

It does not describe an AI/ML-based device, nor does it provide the type of study details requested (e.g., expert ground truth, sample sizes for AI model testing/training, MRMC studies, standalone performance).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text, as this information is not present.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

JJGC Industria e Comercio de Materiais Dentarios SA % Jennifer Jackson Director of Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810

Re: K202282

Trade/Device Name: Neodent Implant System - Zirconia Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: December 30, 2020 Received: December 31, 2020

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 Part 803) for devices or post-marketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 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 Steen Assistant Director DHT1B: Division of Dental 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) K202282

Device Name Neodent Implant System - Zirconia Implant System

Indications for Use (Describe) Indications for Use for PEEK Abutment for Zirconia Implant System:

Type of Use (Select one or both, as applicable)
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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
	(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	26/Jan/2021
Preparer / AlternateContact	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 – Zirconia Implant System
Common Name	Endosseous dental implant abutment
Classification Name	Endosseous dental implant abutment
Classification Regulations	21 CFR 872.3630, Class II
Product Code	NHA
Classification Panel	Dental Products Panel
Reviewing Branch	Dental Devices Branch

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PREDICATE DEVICE INFORMATION

Primary Predicate Device	K163194 – Neodent Implant System – GM Line, JJGC Indústria eComércio de Materiais Dentários S.A
Reference Device	K201491 – Neodent Implant System – Zirconia Implant System,JJGC Indústria e Comércio de Materiais Dentários S.A
Reference Device	K191191 – Neodent Implant System, JJGC Indústria e Comérciode Materiais Dentários S.A
Reference Device	K182620 - MRI Compatibility for Existing Neodent ImplantSystem, JJGC Indústria e Comércio de Materiais Dentários S.A

INDICATIONS FOR USE

SUBJECT DEVICE DESCRIPTIONS

Intended for single use;
Provided sterile via Ethylene Oxide;
The subject devices are manufactured of PEEK (high performance polymer – specific for dental use) and are provided along with a screw manufactured of titanium alloy according to ASTM F136 standard;
. ZiLock prosthetic interface with internal indexer;
. Cylindrical format with a passing hole to fixate the screw.

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TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLES

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
	K202282Neodent Implant System - Zirconia ImplantSystemPEEK CR AbutmentsJJGC Indústria e Comércio de MateriaisDentários S.A.	K163194Neodent Implant System - GM LinePro PEEK AbutmentsJJGC Indústria e Comércio de Materiais DentáriosS.A.	K191191Neodent Implant SystemGM Temporary Abutment for CrownJJGC Indústria e Comércio de Materiais DentáriosS.A.	EquivalenceDiscussion
Indications forUse	Neodentprostheticabutmentsareindicated to be used on Neodent implants toprovide support for prosthetic structures forup to 6 months. They can be used in single-or two-stage procedures and they areintended to be placed out of occlusion.	The Pro PEEK Abutments are indicated to beused on Neodent implants to providetemporary support for prosthesis structurefor up to 6 months. They can be used in oneor two stage procedures and also immediateload when there is good primary stability	The Neodent Implant System is intended tobe surgically placed in the bone of the upperor lower jaw to provide support forprosthetic devices, such as artificial teeth, torestore chewing function. It may be usedwith single-stage or two-stage procedures,for single or multiple unit restorations, andmay be loaded immediately when goodprimary stability is achieved and withappropriate occlusal loading. The NeodentImplant System - Temporary Abutments areindicated to be used on Neodent implants toprovide temporary support for prosthesisstructure for up to 6 months.	EquivalentDespite of the use of different words, theindications for use for the primary predicatedevices and subject devices are the same.•Both are indicated for temporarysupport for a maximum period oftime of 6 months;•Both can be used in one or twostage procedures;•Both can be used for immediateload.
Intended Use	The PEEK CR Abutment for Zirconia is adevice indicated for use in the production ofa single-unit provisional prosthesis onZirconia Implants, installed in maxilla ormandible. It is supplied along with a screwfor fixating the Abutment over the Implant.	The Temporary Abutment is used fortemporary rehabilitation (up to 180 days)with screw-retained single-unit (anti-rotational abutment) or multi-unit(rotational abutment) prostheses.	The Temporary Abutment is used fortemporary rehabilitation (up to 180 days)with screw-retained single-unit (anti-rotational abutment) or multi-unit(rotational abutment) prostheses.	EquivalentSubject devices and predicate devices areindicated for temporary use only.
Implant-	Straight internal connection	GM Morse Taper	GM Morse Taper	Equivalent
Abutmentinterface	indexing features (ZiLock)			Subject devices and predicate devicespresentinternal connection and areequipped with a rotational lock and an innerthread for fixation of the components.
Design	Cylindrical format with a passing hole tofixate the screw and anti-rotationalimplant-	Cylindrical format with a passing hole tofixate the screw and anti-rotationalimplant-	Cylindrical format with grooves to facilitatebonding of acrylicmaterial and	Equivalent
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
	K202282Neodent Implant System - Zirconia ImplantSystemPEEK CR AbutmentsJJGC Indústria e Comércio de MateriaisDentários S.A.	K163194Neodent Implant System - GM LinePro PEEK AbutmentsJJGC Indústria e Comércio de Materiais DentáriosS.A.	K191191Neodent Implant SystemGM Temporary Abutment for CrownJJGC Indústria e Comércio de Materiais DentáriosS.A.	EquivalenceDiscussion
	to-abutment interface	to-abutment interface	circumferential channels to facilitatecustomization of abutment height. Presentsanti-rotationalimplant-to-abutmentinterface	Subject devices and predicate devicespresent the same design and similar anti-rotational feature.
Reusable	No	No	No	IdenticalThe subject devices and the predicate devicesare indicated for single use.
Length (mm)	1.5; 2.5 mm	0.8; 1.5; 2.5; 3.5; 4.5; 5.5 mm	0.8; 1.5; 2.5; 3.5 mm	EquivalentRange of lengths for subject devices iswithin the range of lengths for the primaryand reference predicate devices.
Diameter (Ø)(mm)	4.0; 4.5 mm	4.5; 6.0 mm	3.5; 4.5 mm	EquivalentDiameter of subject devices is within therange of diameters for the primary andreference predicate devices, so the subjectdevices do not represent a worst case interms of performance.
Material	Body and base (implant-to-abutmentinterface): PEEK (high performancepolymer - specific for dental use)Screw: Titanium Alloy (ASTM F136)	Body: PEEK (high performance polymer -specific for dental use)Base (implant-to-abutment interface):Titanium Alloy (ASTM F136)Screw: Titanium Alloy (ASTM F136)	Titanium Alloy (ASTM F136)	EquivalentBoth primary and reference predicatedevices are made of the same raw materials.The main difference between the predicatedevices and subject devices is thecomposition of the subject device bodywhich is only PEEK.
SterilizationMethod	Provided sterile via Ethylene Oxide to anSAL of 1x10-6	Provided sterile via Ethylene Oxide to an SAL of1×10-6	Provided sterile via Ethylene Oxide to an SALof 1x10-6	IdenticalSubject devices and predicate devices areprovided sterile by the same sterilizationmethod.

Table 1. Technological Characteristic Comparison Table

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K202282 – Traditional 510(k)

Neodent Implant System – Zirconia Implant System

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The subject devices have equivalent indications for use as the primary predicate devices. They also present an equivalent range of lengths as the primary and reference devices and equivalent range of diameter as the reference predicate devices, being contemplated within the range of lengths and diameter of the predicate devices.

Subject and predicate devices have implant-to-abutment internal indexing. They present the same sterile barrier system and same sterilization method. The subject devices and primary predicate devices are manufactured of the same materials.

Overall, the subject devices are equivalent to the predicate devices as follows:

same intended use,
. same operating principle,
incorporate the same basic design,
. incorporate the same materials, and
have same packaging and are sterilized using the same materials and processes

PERFORMANCE DATA

Biocompatibility

Biocompatibility for the subject devices was leveraged from the primary predicate device K163194. Ethylene oxide sterilization residuals according to ISO 10993-7 was also leveraged from the primary predicate device K163194.

Bench testing

The subject devices are not intended to be placed in occlusion and are not intended to correct angled implants. Therefore, there would be no forces focusing on them, so the company understands that the Dynamic Fatigue Test is not applicable.

MRI compatibility testing was leveraged from the reference device K182620.

Sterilization validation

The subject devices are sterilized by Ethylene Oxide, according to ISO 11135-1 via the over-kill method. The method achieved a Sterility Assurance Level of 1x10 °.

The Subject devices are not represented to be "pyrogen free".

Bacterial Endotoxin Testing is leveraged from the primary predicate device K163194.

CONCLUSION

The subject devices and the predicate devices have equivalent intended use, design and technological characteristics. Equivalent range of overall dimensions and sterilization method. The data included in this submission demonstrate that the subject devices are substantially equivalent to the 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.)