Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for 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.

PreFace Abutment is a titanium abutment to be used in fabricating a full custom abutment and placed onto Neodent dental implants to provide support for customized prosthetic restorations. PreFace Abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations.

Device Description

The purpose of this submission is to expand the Neodent Implant System components cleared under K101945, K123022, and K133592; these submissions included dental implants with a Morse taper abutment interface, mating abutments, abutment screws, and other associated components. This submission includes the Titanium Base Abutment, provided in two prosthetic platform diameters (3.5 and 4.5 mm), each in five gingival heights (0.8, 1.5, 2.5, 3.5 and 4.5 mm). Titanium Base is an abutment to be used as a base when fabricating a zirconia superstructure. This submission also includes the PreFace Abutment in two overall (milling) diameters of 11.5 and 15.8 mm. The PreFace Abutment with overall (milling) diameter of 15.8 mm is only used to mill an angled abutment.

PreFace is an abutment to be used in fabricating a full custom abutment in titanium alloy. After milling the minimum wall thickness for the PreFace must be no less than 0.4 mm, and the emergence profile diameter must be at least 3.3 mm. The maximum limit for angulation is 30°, and the maximum gingival height is 6 mm from the implant platform. In the case of an angled abutment, the cementable height from the emergence profile (prosthetic height) must not exceed 6 mm. The total height of the abutment (above the implant-abutment connection platform) must be no greater than 14.2 mm and no shorter than 4 mm. The range for the abutment body diameter (above the implant-abutment connection platform) is 3.3 mm. The implant interface must remain intact and cannot be modified.

The subject abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The subject abutments are compatible with Neodent dental implants having the Morse taper interface cleared in K101945, K123022 and K133592.

AI/ML Overview

The provided text is a 510(k) Summary for the Neodent Implant System. It describes a medical device approval and focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics, ground truth, or expert consensus.

Therefore, many of the requested elements regarding acceptance criteria, study design, expert qualifications, and ground truth are not present in this type of regulatory document.

However, I can extract information related to performance data and comparison to predicate devices, which serve as a form of "acceptance criteria" in the context of substantial equivalence.

Here's an attempt to answer your request based on the provided document:

1. A table of acceptance criteria and the reported device performance

In the context of a 510(k) submission, "acceptance criteria" are typically demonstrating substantial equivalence to legally marketed predicate devices through comparison of technological characteristics and performance data. The reported "performance" is that the new device is at least as good as, or substantially equivalent to, the predicates.

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance
Intended Use Equivalence	The subject device and the primary predicate devices have substantially equivalent indications for use, including providing support for customized prosthetic restorations.
Design and Function Equivalence (Titanium Base Abutment)	The subject Titanium Base abutments are substantially equivalent in design, function, size, and material to the Straumann CARES Variobase Abutments (K120822). They are both titanium alloy bonding bases for CAD/CAM zirconia superstructures.
Design and Function Equivalence (PreFace Abutment)	The subject PreFace abutments are substantially equivalent in design, function, size, and material to the Straumann C.A.R.E.S. Titanium Abutment (K052272). Both are abutment blanks for CAD/CAM fabrication of a custom titanium alloy abutment. Each has a precision implant-abutment interface compatible with specific implant systems.
Material Equivalence	The subject device uses Ti-6Al-4V, while predicate devices use Ti-6Al-7Nb. This is considered a "minor difference" but is justified by mechanical testing.
Mechanical Strength (Fatigue Testing)	Mechanical test results demonstrated that the strengths of subject Titanium Base and PreFace abutments are equal to or greater than that of predicate abutments in K120822 and K133421, respectively. (Performance: Fatigue testing according to ISO 14801).
Biocompatibility	Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include biocompatibility. (Performance/Finding: Biocompatible, assumed to meet relevant standards).
Sterilization	Sterilization testing was performed according to ISO 17665-1 and ISO 17665-2. (Performance/Finding: Sterilizable using moist heat, assumed to meet standards, and packaging similar to predicates). The device is "to be sterilized using the same processes" as predicate devices.
Operating Principle	The device uses the same operating principle as predicate devices.
Basic Design	The device incorporates the same basic design as predicate devices.
Packaging	The device has similar packaging to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in the document. The performance data mentioned are "non-clinical" (biocompatibility, engineering analysis, dimensional analysis, mechanical testing, sterilization testing). For mechanical testing (ISO 14801), sample sizes are not detailed, but such standards typically require a specific number of samples for statistically valid testing.
Data Provenance: The document does not specify the country of origin of the data. It is a premarket notification from a Brazilian manufacturer (JJGC Indústria e Comércio de Materiais Dentários SA) to the U.S. FDA, meaning the testing data would typically be generated by or for the manufacturer. The data is non-clinical, likely from laboratory testing. It is not clinical data (no "retrospective or prospective" clinical studies are mentioned).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided in the document. The document describes a medical device (dental implant abutments) that undergoes non-clinical engineering and material testing, not diagnostic performance evaluation requiring ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided in the document. Adjudication methods are typically used in clinical studies or performance evaluations where there's subjectivity and disagreement among reviewers (e.g., in imaging interpretation). The tests described are objective, non-clinical tests (e.g., mechanical fatigue, sterilization parameters).

5. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/imaging devices that assist human interpretation, which is not the nature of the dental implant abutments described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone (algorithm only) performance study was not done. This is not an AI/algorithm-based device. The "performance data" refers to the physical and material properties of the abutments.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable and not provided in the document as it pertains to non-clinical engineering and material testing. The "ground truth" for mechanical testing, for example, would be the physical measurement of failure points or fatigue limits compared against a standard. For biocompatibility, it's compliance with ISO standards.

8. The sample size for the training set

This information is not applicable and not provided in the document. There is no AI or algorithm involved that would require a "training set."

9. How the ground truth for the training set was established

This information is not applicable and not provided in the document as there is no training set mentioned.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 13, 2015

Jjgc Industria E Comercio De Materiais Dentarios S c/o Mr. Kevin Thomas Paxmed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K150367

Trade/Device Name: Neodent Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 27, 2015 Received: May 28, 2015

Dear Mr. Thomas:

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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

lina Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150367

Device Name

Neodent Implant System

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

JJGC Indústria e Comércio de Materiais Dentários SA

Neodent Implant System

July 13, 2015

ADMINISTRATIVE INFORMATION

Manufacturer Name	JJGC Indústria e Comércio de Materiais Dentários S.Av. Juscelino Kubitschek de Oliveira, 3291 - CICCuritiba, Paraná, 81270-200, Brazil
	Telephone:	+55 41 2169 4058
	Fax:	+55 41 2169 1043
Official Contact	Jacson CambruzziHead of Quality and Regulatory Affairs
Representative/Consultant	Kevin A. Thomas, PhDPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130
		Telephone: +1 (858) 792-1235
	Fax:	+1 (858) 792-1236
	Email:	kthomas@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	Neodent Implant System
Common Name	Endosseous dental implant abutment
Classification Name	Endosseous dental implant abutment
Classification Regulation	21 CFR 872.3630, Class II
Product Code	NHA
Classification Panel	Dental Products Panel
Reviewing Branch	Dental Devices Branch

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INTENDED USE

DEVICE DESCRIPTION

PERFORMANCE DATA

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility, engineering analysis, and dimensional analysis. Mechanical testing was performed on the Titanium Base and PreFace abutments according to ISO 14801 Dentistry -Implants - Dynamic fatigue test for endosseous dental implants. Sterilization testing was performed according to ISO 17665-1 Sterilization of health care products - Moist heat -Part 1: Requirements for the development, validation and routine control of a sterilization

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process for medical devices and ISO 17665-2 Sterilization of health care products – Moist heat – Part 2: Guidance on the application of ISO 17665-1. Clinical data were not submitted in this premarket notification.

EQUIVALENCE TO MARKETED DEVICE

Neodent Implant System is substantially equivalent in indications and design principles to the following legally marketed predicate devices:

K120822, Straumann® CARES® Variobase™ Abutments, Institut Straumann AG;

K052272, Straumann C.A.R.E.S. Titanium Abutment, Institut Straumann AG;

K133421, Straumann® Magellan™ Abutment System, Institut Straumann AG;

K133592, Neodent Implant System, Neodent USA, Inc .;

K 123022, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA , and

K101945, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA.

The primary predicate device for the Titanium Base abutment is K120822. The primary predicate device for the PreFace abutment is K052272. The reference predicate devices are K133421, K133592, K123022, and K101945. A comparison of the technological characteristics of the subject device and the primary predicate devices K120822 and K052272 is provided in the following table.

	Subject Device	Primary Predicate Devices
Comparison	JJGC Indústria e Comércio deMateriais Dentários SANeodent Implant SystemK150367	Institut Straumann AGStraumann® CARES® Variobase™AbutmentsK120822	Institut Straumann AGStraumann C.A.R.E.S. TitaniumAbutmentK052272
Indications for Use	Titanium Base Abutment is atitanium base placed onto Neodentdental implants to provide supportfor customized prostheticrestorations. It is indicated forcement-retained single or multi-unitrestorations, or screw-retainedsingle restorations.PreFace Abutment is a titaniumabutment to be used in fabricating afull custom abutment and placedonto Neodent dental implants toprovide support for customizedprosthetic restorations. PreFaceAbutments are indicated for screw-retained single restorations orcement-retained single or multi-unitrestorations.	The Straumann® CARES®Variobase™ Abutment is a two-piece dental abutment consisting ofthe Straumann® Variobase™Abutment and the Straumann®CARES® Variobase™ Copingwhich is intended to be placed ontoStraumann dental implants toprovide support for prostheticreconstruction such as crowns andbridges. Straumann® CARES®Variobase™ Abutments areindicated for screw-retained singletooth or cement-retained singletooth and bridge restorations.The Straumann® CARES®Variobase™ Coping polycon® ae incombination with the Straumann®Variobase™ Abutment is indicatedfor temporary (up to 180 days)dental restoration of a Straumanndental implant.	Abutments are intended to beplaced into dental implants toprovide support for prostheticreconstructions such as crowns orbridges. The Straumann C.A.R.E.S.Titanium Abutment is indicated forcemented restorations. Theabutment can be used in singletooth replacements and multipletooth restorations.
Abutment Characteristics
Design	Titanium Base andCAD/CAM Blank	Titanium Base	CAD/CAM Blank
Prosthesis Attachment	Screw-retainedCement-retained	Cement-retained	Cement-retained

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	Subject Device	Primary Predicate Devices
Comparison	JJGC Indústria e Comércio deMateriais Dentários SANeodent Implant SystemK150367	Institut Straumann AGStraumann® CARES® Variobase™AbutmentsK120822	Institut Straumann AGStraumann C.A.R.E.S. TitaniumAbutmentK052272
Restoration	Single-unitMulti-unit	Single-unitMulti-unit	Single-unitMulti-unit
Abutment Diameter	Titanium Base: 3.5 and 4.5 mmPreFace: 11.5 and 15.8 mm(milling diameter)	3.3 - 6.5 mm	3.3 - 6.5 mm
Abutment Angle	Up to 30°	Up to 30°	Up to 30°
Abutment/ Implant Interface	Indexed	Indexed, non-indexed	Indexed, non-indexed
Abutment Material	Ti-6Al-4V	Ti-6Al-7Nb	Ti-6Al-7Nb
Abutment Screw Material	Ti-6Al-4V	Ti-6Al-7Nb	Ti-6Al-7Nb

The subject device and the primary predicate devices have substantially equivalent indications for use, including providing support for customized prosthetic restorations.

The subject Titanium Base abutments are substantially equivalent in design, function, size, and material to the Straumann CARES Variobase Abutments cleared in K120822. All are titanium alloy bonding bases for CAD/CAM zirconia superstructures. The scanning and designing software used for the zirconia superstructure is the Straumann CARES System (K120822). Final fabrication of the abutment will be done at the Straumann Milling Center. The subject PreFace abutments are substantially equivalent in design, function, size, and material to the Straumann C.A.R.E.S. Titanium Abutment cleared in K052272. Both are abutment blanks for CAD/CAM fabrication of a custom titanium alloy abutment. Each has a precision implant-abutment interface compatible with specific implant systems. The scanning and designing software used for the subject PreFace abutment is the Straumann CARES System (K052272). Final fabrication of the abutment will be done at the Straumann Milling Center.

Minor differences in the technological characteristics of the subject device and primary predicate devices include the option for screw-retained prosthesis attachment, the range of (finished) abutment diameters, the provision of only indexed implant interfaces for the subject devices, and slight differences in the device materials (Ti-6Al-4V for the subject devices and Ti-6A1-7Nb for the primary predicate devices).

Mechanical test results demonstrated that the strengths of subject Titanium Base and PreFace abutments are equal to or greater than that of predicate abutments in K120822 and K133421, respectively.

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510(k) Summary K150367

CONCLUSION

Overall, the subject device has the following similarities to the predicate devices:

has the same intended use,
uses the same operating principle,
incorporates the same basic design, ●
incorporates the same or very similar materials, and ●
has similar packaging and is to be sterilized using the same processes. .

The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

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.)

Indications for Use

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510(k) Summary

JJGC Indústria e Comércio de Materiais Dentários SA

Neodent Implant System

ADMINISTRATIVE INFORMATION

DEVICE NAME AND CLASSIFICATION

INTENDED USE

DEVICE DESCRIPTION

PERFORMANCE DATA

EQUIVALENCE TO MARKETED DEVICE

510(k) Summary K150367

CONCLUSION

§ 872.3630 Endosseous dental implant abutment.

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