NDX Custom Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

Device Description

NDX Custom Abutments are fabricated for a specific prosthetic case and implant interface using a Computer Assisted Design /Computer Assisted Manufacturing (CAD/CAM) scanning and milling process. Milling of NDX Custom Abutments includes anti-rotation features compatible with specific implant systems. Each abutment is made from titanium alloy. It is created according to the specific design parameters designated by the clinician. All components and parameters of the system remain identical to those cleared for the TDS Abutment System predicates. Abutments are available in diameters of 3.5, 4.1, 4.3, 5.0, 5.1, and 6.0 mm, and can be fabricated straight or with an angle up to 30°.

AI/ML Overview

The provided text describes the 510(k) summary for NDX Custom Abutments, a dental device. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices.

Here's an analysis of the requested information based on the provided text:

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

Acceptance Criteria	Reported Device Performance
Material Strength and Compatibility (for intended use)	Mechanical testing was conducted on worst-case constructs of NDX titanium abutments according to ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants).
Fatigue Strength (for intended use)	Results showed adequate strength for their intended use based on ISO 14801.
Fit and Compatibility with Implant Systems	Extensive compatibility testing was performed. Multiple parameters of the NDX abutments and corresponding implants with designated screws were evaluated to determine appropriate fit.
Manufacturing Process Performance	All component designs and parameters of the system remain identical to those previously cleared for the TDS CAD/CAM Abutment System. Non-clinical testing data included engineering analysis, dimensional analysis, static and dynamic compression-bending testing according to ISO 14801, and sterilization validation according to ISO 17665.
Substantial Equivalence to Predicate Devices	The data in this submission demonstrates substantial equivalence to the predicate devices (TDS Abutment for Friadent Xive - K103339, TDS Titanium Abutment for Nobel Biocare Bränemark - K091392, TDS Abutment for Nobel Biocare Replace - K091026, and TDS Abutment - K081460). NDX Custom Abutments have the same intended use, operating principle, design, materials, packaging, and sterilization processes as the 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)

The document does not explicitly state the sample size for the mechanical and compatibility testing. It mentions "worst-case constructs" for mechanical testing and "multiple parameters" for compatibility testing. The data provenance is not specified, but it can be inferred that the testing was conducted by or for National Dentex Corporation to support their 510(k) submission in the USA. The study design (retrospective or prospective) is not explicitly mentioned but non-clinical testing is typically done prospectively as part of device development and validation.

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 device is an implantable medical device (dental abutment), not an AI/diagnostic software. The concept of "ground truth" established by experts in the context of diagnostic performance (like a radiologist reading an image) does not directly apply here. The "truth" for this type of device is established through engineering principles, material science, and mechanical testing against recognized standards (like ISO 14801). Therefore, no number of experts for "ground truth" in the diagnostic sense is applicable or mentioned. The expertise involved would be in engineering and materials science for conducting and interpreting the tests.

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or diagnostic performance studies where multiple human readers assess cases and discrepancies need to be resolved. This is a non-clinical submission for a physical device. Therefore, no adjudication method of this type is applicable or mentioned. The determination of "passing" or "failing" acceptance criteria is based on objective measurements and comparison to predefined standards (e.g., ISO 14801).

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, an MRMC comparative effectiveness study was not done. This device is a physical dental abutment, not an AI or diagnostic software intended to assist human readers.

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

This question is not applicable. The device is a physical dental abutment, not an algorithm. What was done was standalone mechanical and dimensional testing of the abutment itself.

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

The "ground truth" for this device is established through:

International Standards: Specifically, ISO 14801 for dynamic fatigue testing. Compliance with this standard sets the "truth" for mechanical performance.
Engineering and Dimensional Specifications: The precise dimensions, material properties, and fit parameters are defined by engineering drawings and measurements.
Predicate Device Equivalence: A significant part of the "truth" for substantial equivalence is demonstrating that the NDX Custom Abutments match the established characteristics (intended use, operating principle, design, materials, packaging, sterilization) of the legally marketed predicate devices.

8. The sample size for the training set

This question is not applicable. This is a physical device, not a machine learning algorithm that requires a "training set."

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

This question is not applicable as there is no training set for this type of device.

Summary

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510(k) Summary

K121117

National Dentex Corporation

NDX Custom Abutments

December 13, 2012

DEC 1 4 2012

ADMINISTRATIVE INFORMATION

Manufacturer Name:

National Dentex Corporation 2 Vision Drive Natick, MA 01760 Telephone: +1 (508) 907-7800 Fax: +1 (508) 907-6050

Official Contact:

Dell Dine

Representative/Consultant:

Linda Schulz or Kevin Thomas PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: +1 (858) 792-1235 Fax: +1 (858) 792-1236 Email: lschulz@paxmed.com kthomas@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: NDX Custom Abutments Classification Name: Abutment, Implant, Dental, Endosseous Classification Regulations: Endosseous dental implant 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

NDX Custom Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

NDX Abutment for Nobel Biocare Bränemark is compatible with the following implant systems:
Nobel Biocare:	Bränemark System® Mk III Groovy
	Bränemark System® Mk III Shorty
	Bränemark System® Zygoma
	NobelSpeedy Groovy
	NobelSpeedy Shorty
NDX Abutment for Nobel Biocare Replace is compatible with the following implant systems:
Nobel Biocare:	Nobel Replace® Select Straight
	Nobel Replace Select Straight One Stage
	Replace Select Tapered
	Replace Select Tapered One Stage
	Nobel Replace Straight
	Nobel Replace Tapered
	Nobel Replace Straight Groovy
	Nobel Replace Tapered Groovy for the 3.5 mm (NP)
	4.3 mm (RP), 5.0 mm (WP) and 6.0 mm implants
NDX Abutment for Nobel Active is compatible with the following implant system:
Nobel Biocare:	NobelActive Implant
NDX Abutment for 3i External Hex is compatible with the following implant systems:
3i:	NanoTite External Hex Connection Implants
	Full OSSEOTITE External Hex Connection Implants
	OSSEOTITE External Hex Connection Implant
NDX Abutment for 3i Certain Internal is compatible with the following implant system:
3i:	Certain Internal Connection

DEVICE DESCRIPTION

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EQUIVALENCE TO MARKETED DEVICE

National Dentex submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, NDX Custom Abutments is substantially equivalent in indications and design principles to the following predicate devices, all manufactured by Pou Yu Biotechnology Co., Ltd.:

TDS Abutment for Friadent Xive - K103339. TDS Titanium Abutment for Nobel Biocare Bränemark - K091392, TDS Abutment for Nobel Biocare Replace - K091026, and TDS Abutment - K081460

The purpose of this submission is to give National Dentex Corporation the ability to utilize the currently cleared TDS CAD/CAM Abutment System for dental implant abutment fabrication. All component designs and parameters of the system remain identical to those previously cleared for the TDS CAD/CAM Abutment System.

Mechanical testing was conducted on worst-case constructs of NDX titanium abutments according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants and results showed adequate strength for their intended use. Extensive compatibility testing was performed in support of NDX Abutments. Multiple parameters of the NDX abutments and corresponding implants with designated screws were evaluated to determine appropriate fit.

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: engineering analysis, dimensional analysis, static and dynamic compression-bending testing according to ISO 14801, and sterilization validation according to ISO 17665.

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

Overall, NDX Custom Abutments have the following similarities to the predicate devices:

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.

Public Health Service

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

December 14, 2012

National Dentex Corporation C/O Ms. Linda K. Schulz PaxMed International, Limited Liability Company 12264 El Camino Real, Suite 400 SAN DIEGO CA 92130

Re: K121117

Trade/Device Name: NDX Custom Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 3, 2012 Received: December 5, 2012

Dear Ms. Schulz:

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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Page 2 - Ms. Schulz

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

Sincerely yours,

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

2012.12.14 Susan Runner DDS, MA 14:09:38 -05'00' Anthony D. Watson, B.S., M.S., M.B.A. 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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510(k) Premarket Notification

NDX Custom Abutments

Indications for Use

510(k) Number: K121117

NDX Custom Abutments Device Name:

Indications for Use:

multudions for ober tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

NDX Abutment for Nobel Biocare Branemark is compatible with the following implant systems: Nobel Biocare: Branemark System® Mk III Groovy

Bränemark System® Mk III Shorty

Bränemark System® Zygoma

NobelSpeedy Groovy

NobelSpeedy Shorty

NDX Abutment for Nobel Biocare Replace is compatible with the following implant systems:

Nobel Biocare: Nobel Replace® Select Straight

Nobel Replace Select Straight One Stage

Replace Select Tapered

Replace Select Tapered One Stage

Nobel Replace Straight

Nobel Replace Tapered

Nobel Replace Straight Groovy

Nobel Replace Tapered Groovy for the 3.5 mm (NP)

4.3 mm (RP), 5.0 mm (WP) and 6.0 mm implants

NDX Abutment for Nobel Active is compatible with the following implant system: Nobel Biocare: NobelActive Implant

NDX Abutment for 3i External Hex is compatible with the following implant systems:

NanoTite External Hex Connection Implants

Full OSSEOTITE External Hex Connection Implants

OSSEOTITE External Hex Connection Implant

NDX Abutment for 31 Certain Internal is compatible with the following implant system: Certain Internal Connection 3i:

X Prescription Use (Part 21 CFR 801 Subpart D)

3i:

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

2012.12.14 Susan Runner DDS, MA -14:08:29 -05'00'

(Division Sign-Off) (Division of Anestheslology, General Hospital Infection Control, Dental Devices

510(k) Number:

Page 6 of 19

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.)