Nobel Biocare's Zygoma implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function. The Zygoma Implants may be put into immediate function provided that stability requirements detailed in the directions for use are satisfied.

Device Description

Nobel Biocare's NobelZygoma 45° implants are threaded, root-form titanium dental implants intended to extend through the maxillary sinus into the Zygomaticus bone to support prosthetic devices, such as artificial teeth, in order to restore chewing function.

The NobelZygoma 45° implants are available in lengths between 30 and 52.5 mm and have a 4.5 mm external hex connection. They are made of commercially pure titanium and have the Nobel Biocare TiUnite surface treatment.

AI/ML Overview

This document is a 510(k) premarket notification for a dental implant, the NobelZygoma 45°. It does not describe an AI/ML powered device, nor does it present clinical performance data in the typical sense of acceptance criteria for diagnostic accuracy or efficacy. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and shared characteristics.

Therefore, the requested information elements related to AI/ML device performance, human readers, ground truth establishment, and training/test set details cannot be extracted from this document in their typical form.

However, I can extract and present the available information regarding the device's technical specifications and how its performance was evaluated to demonstrate substantial equivalence, which is the primary "acceptance criterion" for a 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance (Focus on Substantial Equivalence and Non-Clinical Testing for Dental Implants)

For this type of device, "acceptance criteria" are generally tied to demonstrating that the new device is as safe and effective as a legally marketed predicate device. The primary "study" is a comparative performance test.

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (NobelZygoma 45°)
Material Composition Equivalence	Device Material: CP Titanium grade 4 (Same as predicate)
Surface Treatment Equivalence	Surface: TiUnite (Same as predicate)
Sterilization Method Equivalence	Sterilization Method: Gamma radiation (Same as predicate, validated to ANSI/AAMI/ISO 11137). No additional testing required.
Packaging Equivalence	Packaging: Same as predicate (titanium cylinder in plastic vial with PVC shrinkwrap and tamper resistant strip). No additional testing required.
Shelf Life Equivalence	Shelf Life: Same as predicate (5 years expiration, determined by real-time aging). No additional testing required.
Biocompatibility Equivalence	Biocompatibility: Manufactured from same material with same method as predicate, same intended use and patient contact type/duration. No additional testing required.
Mechanical Performance (Fatigue Limit)	Fatigue Limit: Determined using a modified version of ISO 14801. Both NobelZygoma 45° (candidate) and Zygoma Implant (predicate) were tested under identical conditions. Specific numerical results for fatigue limit are not provided in this excerpt, only that the testing was performed and used to address substantial equivalence. The conclusion is that the device has been shown to be substantially equivalent to the predicate.
Intended Use/Indications for Use Equivalence	Indications for Use: "Nobel Biocare's Zygoma implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arches to provide support for prosthetic devices such as artificial teeth in order to restore patient esthetics and chewing function. The Zygoma Implants may be put into immediate function provided that stability requirements detailed in the directions for use are satisfied." (Identical to predicate's indications, with minor wording change from "manual" to "directions for use").

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not explicitly stated as a numerical value for a typical clinical test set. The "test set" in this context refers to the samples of the NobelZygoma 45° device and the predicate device used for mechanical fatigue testing. The document states "Both the subject and predicate device were tested under identical conditions," implying multiple units were tested to determine the fatigue limit, but the exact number is not provided.
Data Provenance: The document is a regulatory submission for a dental implant manufactured by Nobel Biocare AB (Sweden) and submitted by Nobel Biocare USA LLC (USA). The testing described is non-clinical (mechanical), performed to demonstrate the device's physical properties.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This concept is not applicable as this is a non-clinical, mechanical device. "Ground truth" for a dental implant's mechanical properties is derived from standardized testing methods (e.g., ISO 14801), not expert consensus in the diagnostic sense.

4. Adjudication Method (for the test set):

Not applicable as this is a mechanical device with non-clinical performance data, not subject to human adjudication for a test set.

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:

Not applicable. This document is for a physical medical device (dental implant), not an AI/ML-powered diagnostic or assistive tool.

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

Not applicable. This document is for a physical medical device (dental implant).

7. The type of ground truth used:

For the mechanical performance testing (fatigue limit), the "ground truth" is defined by the objective measurements obtained through the standardized mechanical test method (modified ISO 14801).

8. The sample size for the training set:

Not applicable. This document is for a physical medical device (dental implant), not an AI/ML device that requires a training set.

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

Not applicable. No training set is involved.

Summary

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

March 16, 2016

Nobel Biocare AB c/o Mr. Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K152093

Trade/Device Name: NobelZygoma 45° Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: February 11, 2016 Received: February 12, 2016

Dear Mr. Chua:

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 (OS) 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,

Tina 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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Form Approved: OMB No.	0910-0120
Expiration Date:	January 31, 2017
See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

510(k) Number (if known)	K152093
Device Name	NobelZygoma 45°
Indications for Use (Describe)	Nobel Biocare's Zygoma implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function. The Zygoma Implants may be put into immediate function provided that stability requirements detailed in the directions for use are satisfied.

510(k) Number (if known)

K152093

Device Name

NobelZygoma 45°

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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FORM FDA 3881 (1/14)	Page 1 of 1
FEB 2016	K152093-S001
	Page 16 of 68
	PSC Publishing Services (301) 443-6740 EF

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I. SUBMITTER

Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden

Submitted by: Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887

Contact Person: Charlemagne Chua, Senior Regulatory Affairs Manager Phone: (714) 282-4800 x 7830 Fax: (714) 998-9348

Date Prepared: July 24, 2015 (revised March 10, 2016)

II. DEVICE

Name of Device: NobelZygoma 45° Common or Usual Name: Endosseous Dental Implant Classification Name: Endosseous Dental Implant (21 CFR 872.3640) Regulatory Class: II Product Code: DZE

III.PREDICATE DEVICE

Nobel Biocare – Zygoma Implant (K070182)

IV. DEVICE DESCRIPTION

A.4.

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V. INDICATIONS FOR USE

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VI. Comparison of Technological Characteristics

characteristic	CANDIDATE	PREDICATE
	NobelZygoma 45°	Zygoma Implant (K070182)
Features	Thread Design	Single lead thread	Single lead thread
	Implant Body Design	Parallel wall with 2 diameters transition at 2 mm from platform- 4.5 mm at the platform- 3.9 mm at the apexThreads starting 18 mm from apex	Parallel wall with 2 diameters transition at 13.7 mm from platform- 4.4 mm at the platform- 3.9 mm at the apexThreads starting 2.8 mm from apex
	Implant Tip Design	Tapered with cut out flutes.	Rounded with through hole
	Implant Length	30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5 mm	30, 35, 40, 42.5, 45, 47.5, 50, 52.5 mm
	Connection Type	45° angled 4.0 mm external hex	45° angled 4.0 mm external hex
	Compatible Abutments	Zygoma system Multi-unit abutments	Zygoma system Multi-unit abutments
	Restoration compatibility	Fixed bar	Fixed Bar
	Device Material	CP Titanium grade 4	CP Titanium grade 4
	Surface	TiUnite	TiUnite

	Intended Use/ Principles of Operation	Nobel Biocare's Zygoma implants are endosseous implants and are integrated in the zygomatic bone (osseointegration). They are intended to be used for anchoring or supporting tooth replacements to restore chewing function.	Nobel Biocare's Zygoma implants are endosseous implants and are integrated in the zygomatic bone (osseointegration). They are intended to be used for anchoring or supporting tooth replacements to restore chewing function.
	Indications for Use	Nobel Biocare's Zygoma implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arches to provide support for prosthetic devices such as artificial teeth in order to	Nobel Biocare's Zygoma implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arches to provide support for prosthetic devices such as artificial teeth in order to
characteristic	CANDIDATE	PREDICATE
	NobelZygoma 45°	Zygoma Implant (K070182)
	restore patient esthetics and chewing function. TheZygoma Implants may be put into immediate functionprovided that stability requirements detailed in thedirections for use are satisfied.	restore patient esthetics and chewing function. TheZygoma Implants may be put into immediate functionprovided that stability requirements detailed in themanual are satisfied.

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Analysis of Differences Between Subject Device and Predicate

The subject NobelZygoma 45° implants have a fundamentally similar design as the predicate Zyqoma Implants (K070182). The two implant designs share the same materials, manufacturing methods, and use the TiUnite surface treatment. The two designs have the same 45° anqulated platform and use the same abutments and surgical tooling. The two designs are available in lengths from 30 to 52.5 mm. The illustrations below show the subject NobelZygoma 45° implant next to the predicate Zygoma Implant.

of Personal of all be life of the labor of the
------------------------------------------------	--

NobelZvgoma 45°

Image /page/7/Picture/4 description: The image shows a long, silver-colored, cylindrical object that appears to be a screw or bolt. The object has a series of ridges or threads running along its length, and one end has a hole or slot, while the other end is pointed. The screw is likely made of metal and is designed to be inserted into a material to hold it in place.

Zyqoma Implant (K070182)

Although the subject and predicate devices share many similarities, a number of design characteristics have been changed. These changes are listed below.

-The tip of the NobelZygoma 45° has been modified to a tapered design with flutes to facilitate bone cutting. The predicate Zygoma Implant has a rounded tip with through hole.
-The threads of the NobelZygoma 45° start at the implant apex and extend 18 mm. The threads of the predicate start 2.8 mm from the apex and extend to the platform.
-The profile of the NobelZygoma 45° is different from the predicate. Both implants are parallel walled with 2 diameters. The NobelZygoma 45° has a diameter of 4.5 mm at the platform and a diameter of 3.9 mm starting from 2 mm below the platform. The predicate Zygoma Implant is 4.4 mm at the platform and 3.9 mm starting 13.7 mm from the platform

Summary:

These changes were made to modify the implant design to better adapt to situations of advanced jaw bone resorption in which Zygomatic implants are being used. The changes do not raise different questions of safety or effectiveness compared to the predicate. Differences in technology were evaluated through comparative performance testing.

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VII. PERFORMANCE DATA

Summary of Non-Clinical Testing:

Since the subject device does not represent a new worst case, data from the predicate device was leveraged in the following aspects of the 510(k).

-Sterile Device Information
- The sterilization method for the subject device is the same as the o predicate. The sterilization method is Gamma radiation and has been validated in accordance with ANSI/AAMI/ISO 11137. Therefore, no additional testing was required.
-Device Packaging
- The packaging for the subject device is the same as the predicate. o This is a titanium cylinder placed in a plastic vial with PVC shrinkwrap and tamper resistant strip. Therefore, no additional testing was required.
Shelf Life
- o The packaging for the subject device is the same as the predicate and is labeled with a 5 year expiration date. Real time aging was used to determine the expiration dating. Therefore, no additional testing was required.
Biocompatibility -
- The subject device is manufactured from the same material using o the same manufacturing method as the predicate, has the same intended use, and the same patient contact type and duration. Therefore, no additional testing was required.

The fatigue limit of the NobelZygoma 45° was determined using a modified version of ISO 14801. The modifications to ISO 14801 were done to reflect the likely worst-case clinical use of the device. Both the subject and predicate device were tested under identical conditions. The results of the testing were used to address questions related to substantial equivalence based on difference in design between the subject and predicate devices.

VIII. CONCLUSIONS

The NobelZygoma 45° was evaluated for substantial equivalence using standard and/or comparative testing. In cases where the NobelZygoma 45° could be shown to not represent a worst-case with respect to the Zygoma Implant, data from the predicate device was leveraged to support the subject device. Based on technological characteristics and non-clinical test data included in this submission, the NobelZygoma 45° has been shown to be substantially equivalent to the Zygoma Implant.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.