K Number

Device Name

Neodent Implant System - Zirconia Implant System

Manufacturer

JJGC Industria e Comercio de Materiais Dentarios SA

Date Cleared

2021-01-29

(170 days)

Product Code

NHA

Regulation Number

872.3630

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K163194

Reference Devices

K201491, K191191, K182620

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and biocompatibility of a temporary dental abutment, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

No.
The device provides support for prosthetic structures for up to 6 months. It is not intended to treat or prevent a disease or condition.

Diagnostic

Explanation: The device is a temporary abutment used to support prosthetic structures on implants. Its stated purpose is mechanical support for up to six months, not to diagnose medical conditions or diseases.

SaMD (Software as a Medical Device)

The device description explicitly states it is a temporary abutment composed of PEEK with a titanium alloy fixation screw, which are physical hardware components.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Device Description and Intended Use: The description clearly states that the Neodent prosthetic abutments are intended to be used on Neodent implants to provide support for prosthetic structures within the body. They are placed in the bone of the jaw.
Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical support for a dental prosthesis.

Therefore, based on the provided information, this device is a medical device intended for surgical implantation and support, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

NHA

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

maxilla or mandible (implants)

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)

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.

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.

K163194

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.

K201491, K191191, K182620

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

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.

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

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)
-------------------------------------------------

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 / 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 – 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

PREDICATE DEVICE INFORMATION

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

TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLES

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
	K202282
Neodent Implant System - Zirconia Implant
System
PEEK CR Abutments
JJGC Indústria e Comércio de Materiais
Dentários S.A.	K163194
Neodent Implant System - GM Line
Pro PEEK Abutments
JJGC Indústria e Comércio de Materiais Dentários
S.A.	K191191
Neodent Implant System
GM Temporary Abutment for Crown
JJGC Indústria e Comércio de Materiais Dentários
S.A.	Equivalence
Discussion
Indications for
Use	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.	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	The Neodent Implant System is intended to
be surgically placed in the bone of the upper
or lower jaw to provide support for
prosthetic devices, such as artificial teeth, to
restore chewing function. It may be used
with single-stage or two-stage procedures,
for single or multiple unit restorations, and
may be loaded immediately when good
primary stability is achieved and with
appropriate occlusal loading. The Neodent
Implant System - Temporary Abutments are
indicated to be used on Neodent implants to
provide temporary support for prosthesis
structure for up to 6 months.	Equivalent
Despite of the use of different words, the
indications for use for the primary predicate
devices and subject devices are the same.
•
Both are indicated for temporary
support for a maximum period of
time of 6 months;
•
Both can be used in one or two
stage procedures;
•
Both can be used for immediate
load.
Intended Use	The PEEK CR Abutment for Zirconia is a
device indicated for use in the production of
a single-unit provisional prosthesis on
Zirconia Implants, installed in maxilla or
mandible. It is supplied along with a screw
for fixating the Abutment over the Implant.	The Temporary Abutment is used for
temporary rehabilitation (up to 180 days)
with screw-retained single-unit (anti-
rotational abutment) or multi-unit
(rotational abutment) prostheses.	The Temporary Abutment is used for
temporary rehabilitation (up to 180 days)
with screw-retained single-unit (anti-
rotational abutment) or multi-unit
(rotational abutment) prostheses.	Equivalent
Subject devices and predicate devices are
indicated for temporary use only.
Implant-	Straight internal connection	GM Morse Taper	GM Morse Taper	Equivalent
Abutment
interface	indexing features (ZiLock)			Subject devices and predicate devices
present
internal connection and are
equipped with a rotational lock and an inner
thread for fixation of the components.
Design	Cylindrical format with a passing hole to
fixate the screw and anti-rotational
implant-	Cylindrical format with a passing hole to
fixate the screw and anti-rotational
implant-	Cylindrical format with grooves to facilitate
bonding of acrylic
material and	Equivalent
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
	K202282
Neodent Implant System - Zirconia Implant
System
PEEK CR Abutments
JJGC Indústria e Comércio de Materiais
Dentários S.A.	K163194
Neodent Implant System - GM Line
Pro PEEK Abutments
JJGC Indústria e Comércio de Materiais Dentários
S.A.	K191191
Neodent Implant System
GM Temporary Abutment for Crown
JJGC Indústria e Comércio de Materiais Dentários
S.A.	Equivalence
Discussion
	to-abutment interface	to-abutment interface	circumferential channels to facilitate
customization of abutment height. Presents
anti-rotational
implant-to-abutment
interface	Subject devices and predicate devices
present the same design and similar anti-
rotational feature.
Reusable	No	No	No	Identical
The subject devices and the predicate devices
are 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	Equivalent
Range of lengths for subject devices is
within the range of lengths for the primary
and reference predicate devices.
Diameter (Ø)
(mm)	4.0; 4.5 mm	4.5; 6.0 mm	3.5; 4.5 mm	Equivalent
Diameter of subject devices is within the
range of diameters for the primary and
reference predicate devices, so the subject
devices do not represent a worst case in
terms of performance.
Material	Body and base (implant-to-abutment
interface): PEEK (high performance
polymer - 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)	Equivalent
Both primary and reference predicate
devices are made of the same raw materials.
The main difference between the predicate
devices and subject devices is the
composition of the subject device body
which is only PEEK.
Sterilization
Method	Provided sterile via Ethylene Oxide to an
SAL of 1x10-6	Provided sterile via Ethylene Oxide to an SAL of
1×10-6	Provided sterile via Ethylene Oxide to an SAL
of 1x10-6	Identical
Subject devices and predicate devices are
provided sterile by the same sterilization
method.

Table 1. Technological Characteristic Comparison Table

K202282 – Traditional 510(k)

Neodent Implant System – Zirconia Implant System

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.