Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a mechanical dental implant system and temporary abutments. There is no mention of AI, ML, image processing, or any software-driven features that would suggest the use of these technologies. The performance studies are focused on mechanical and biological properties.

Therapeutic

No
A therapeutic device is one that treats or cures a disease or condition. This device is used to support prosthetic devices to restore chewing function, which is a functional restoration rather than a treatment of a disease.

Diagnostic

No
The device, a temporary abutment for dental implants, is intended for supporting prosthetic devices and restoring chewing function. It is not described as providing diagnostic information or identifying a disease or condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical implant system made of titanium alloy, intended for surgical placement. It is a hardware device.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices 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 provided information clearly describes a dental implant system and temporary abutments that are surgically placed in the bone to support prosthetic devices. This is a device used in vivo (within the body), not in vitro (outside the body).
Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, reagents, or laboratory procedures typically associated with IVDs.

The device described is a dental implant system, which is a type of medical device used for surgical implantation.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

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

NHA

Device Description

Temporary Abutment for provisional restoration employed for up to 6 months;
Intended for single use;
Provided sterile via ethylene oxide gas;
Constructed of titanium alloy (Ti6Al4v-ELI) per ASTM F136;
Coronal geometry has grooves to facilitate bonding of acrylic material;
Abutment is screw-retained;
. Coronal geometry contains channels to facilitate reduction of abutment height;
Provided in anti-rotational and rotational versions supporting single and multi-unit restorations, respectively;
. Provided in multiple gingival heights;
Implant-to-abutment interface compatible with GM implants of the Neodent Implant System.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

bone of the upper or lower jaw

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)

Dynamic fatigue test per ISO 14801 was performed to determine the fatigue strength for the worst-case implant construct assembled with GM Temporary Abutments for multi-unit restorations, according to FDA Guidance.
Torsion testing was performed to evaluate the GM Temporary Abutments Screws under static torsional loading.
Sterilization of the subject abutments via ethylene oxide gas using the overkill method has been validated according to the requirements of ISO 1135. 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.
Accelerated and Real Time Aging tests were performed according to ASTM F1980. The Shelf Life of the subject devices is 5-years.
Biological Safety Assessment guided by ISO 10993-1.
Cytotoxicity testing was performed per ISO 10993-5.
Chemical characterization was performed per ISO 10993-18.
Biocompatibility sample preparation was performed per ISO 10993-12.

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.

K093027, K092814, K103084

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 shows 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 5, 2019

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: K191191

Trade/Device Name: Neodent Implant System - Temporary Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: November 1, 2019 Received: November 4, 2019

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.

Srinivas Nandkumar, Ph.D. 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) K191191

Device Name

Neodent Implant System - Temporary Abutments

Indications for Use (Describe)

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.

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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K191191 – 510(k) Summary

ADMINISTRATIVE INFORMATION

| Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA
(dba Neodent)
Av. Juscelino Kubitschek de Olivera, 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 | 04/Dec/2019 | | |
| Preparer / Alternate Contact | Mariana Soares Hartmann
Regulatory Affairs Analyst
E-mail: mariana.hartmann@neodent.com | | |
| DEVICE NAME AND CLASSIFICATION | | | |
| Trade/ Proprietary Name | Neodent Implant System - Temporary Abutments | | |
| 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 Predicate Devices | K093027 - STRAUMANN RC TEMPORARY ABUTMENTS
Straumann Manufacturing, INC. | | |

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K092814 – STRAUMANN DENTAL ABUTMENTS, Straumann Manufacturing, INC.

K103084 - Neodent Graft Screw, JJGC Indústria e Comércio de Materiais Dentários S.A.

INDICATIONS FOR USE

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.

SUBJECT DEVICE DESCRIPTIONS

Temporary Abutment for provisional restoration employed for up to 6 months;
Intended for single use;
Provided sterile via ethylene oxide gas;
Constructed of titanium alloy (Ti6Al4v-ELI) per ASTM F136;
Coronal geometry has grooves to facilitate bonding of acrylic material;
Abutment is screw-retained;
. Coronal geometry contains channels to facilitate reduction of abutment height;
Provided in anti-rotational and rotational versions supporting single and multi-unit restorations, respectively;
. Provided in multiple gingival heights;
Implant-to-abutment interface compatible with GM implants of the Neodent Implant System.

TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE
	Neodent Implant System	K163194
Neodent Implant System - GM Line	EQUIVALENCE DISCUSSION
Indications
for Use	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.	Indications for Use for GM implants and
conventional abutments:
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.
Indications for Use for GM Titanium Base
abutments:
Titanium Base Abutment is a titanium
base placed onto Neodent dental
implants to provide support for	Equivalent
The subject device is a temporary
abutment for use with GM implants,
therefore only the first paragraph of the
Indications of the primary predicate are
relevant. The subject submission does
not include Titanium Base Abutments or
ProPEEK Abutments.
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	EQUIVALENCE DISCUSSION
	Neodent Implant System	K163194
Neodent Implant System - GM Line
		customized prosthetic restorations. It is
used with a coping and crown, or crown
alone, and is indicated for cement-
retained single or multi-unit
restorations, or screw-retained single
restorations.
		All digitally designed copings and/or
crowns for use with the Neodent
Titanium Base Abutment System are
intended to be sent to Straumann for
manufacture at a validated milling
center.
		Indications for Use for GM Pro Peek
Abutments:
		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.
Interface	GM	GM	Same
Design	Straight, cylindrical with retention rings	Straight and cylindrical	Equivalent
Reusable	No	No	Same
Gingival Height	0.8; 1.5; 2.5 and 3.5 mm	0.8; 1.5; 2.5; 3.5; 4.5 and 5.5 mm	Equivalent
Subject devices within range established
by predicate devices
Diameter ( $Ø$ )	3.5 and 4.5 mm	3.3 and 4.5 mm	Equivalent
Angulation	Straight	Straight, 17° and 30°	Same
Subject devices are straight which is the
same as the straight predicate devices.
Material	TAV (ASTM F136)	Implants:
Titanium grade 4
Conventional abutments:
Titanium alloy Ti-6Al-4V ELI
CAD/CAM abutments:
Titanium alloy Ti-6Al-4V ELI
Temporary abutments:
Titanium alloy Ti-6Al-4V PEEK	Same
Subject devices are the same material as
the TAV predicate devices.
Duration of use
(maximum)	180 days	Lifetime	Equivalent
Subject devices within range established
by primary predicate. Subject devices
same as for reference predicates per
K093027 and K092814
Sterilization
Method	Ethylene Oxide to an SAL of 1x10-6	Ethylene Oxide to an SAL of 1x10-6	Same

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The subject devices and the primary predicate device K163194 have equivalent Indications for Use, similar design, range of gingival height, same raw material and same sterilization method.

PERFORMANCE DATA

Dynamic fatigue test per ISO 14801 was performed to determine the fatigue strength for the worst-case implant construct assembled with GM Temporary Abutments for multi-unit restorations, according to FDA Guidance.

Torsion testing was performed to evaluate the GM Temporary Abutments Screws under static torsional loading.

Sterilization of the subject abutments via ethylene oxide gas using the overkill method has been validated according to the requirements of ISO 1135. A minimum Sterility Assurance Level (SAL) of 1 x 106 has been validated.

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

Accelerated and Real Time Aging tests were performed according to ASTM F1980. The Shelf Life of the subject devices is 5-years.

Biological Safety Assessment guided by ISO 10993-1.

Cytotoxicity testing was performed per ISO 10993-5.

Chemical characterization was performed per ISO 10993-18.

Biocompatibility sample preparation was performed per ISO 10993-12.

CONCLUSION

The subject devices and the primary predicate devices K163194 have the same intended use, similar designs and technological characteristics, and are made of the same materials. The data included in this submission demonstrate that the subject device is substantially equivalent to the predicate device.