NobelProcera® HT ML FCZ Bridge is indicated for use as core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function.
NobelProcera® HT ML FCZ Bridge is indicated for use as a bridge that will be cemented on natural teeth or artificial abutments.

Device Description

NobelProcera®HT ML FCZ Bridge is an individualized cement retained dental restoration manufactured from translucent multi-layered zirconia material.
NobelProcera® HT ML FCZ Bridge is intended to be a replacement for a natural teeth. After finalizing the NobelProcera®HT ML FCZ Bridge in the dental laboratory, it is cemented or bonded on prepared teeth or artificial abutments by a clinician, to provide a natural tooth like appearance and to restore chewing functionality in the patient's mouth. To achieve esthetics and required value and chroma of the surrounding natural teeth the NobelProcera® HT ML FCZ Bridge is suitable for cut-back (veneering) or stain and glaze techniques.
The design of the NobelProcera® HT ML FCZ Bridge is determined in a dental laboratory, hospital or dental practice by scanning, designing and ordering the bridge using NobelDesign or supported third party CAD systems. The bridge, once ordered, is sent electronically to one of NobelProcera's centralized milling centers for fabrication.
The NobelProcera® HT ML FCZ Bridge is manufactured from a solid piece of yitria-stabilized tetragonal zirconia. It is available in 6 shades and for bridges between 2 and 14 units.

AI/ML Overview

This looks like a 510(k) summary for a dental bridge, and as such, it does not contain the kind of performance study details you'd typically find for a device with complex algorithms or AI components that require clinical validation against acceptance criteria. The device is a physical dental prosthetic, not a software or AI-driven diagnostic tool.

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the way you've outlined for AI or software validation.

Therefore, many of the requested fields cannot be filled as they are not applicable to the type of device and submission described.

Here's an attempt to address your request based only on the provided text, noting where information is not available or not applicable:

Acceptance Criteria and Device Performance Study for NobelProcera® HT ML FCZ Bridge

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not Explicitly Stated for this Device Type)	Reported Device Performance (Implied by Substantial Equivalence and Material Clearance)
Biocompatibility: Device material is safe for patient contact.	The subject device is manufactured entirely from the zirconia cleared under K143439. It has the same intended use, patient contact type, and duration as the predicate. No additional testing was required.
Mechanical Performance/Durability: Appropriate for use as a dental bridge.	The NobelProcera HT ML FCZ Bridge is made entirely from the Katana Zirconia material (K143439), which is cleared for the manufacture of bridges. No additional performance testing was deemed necessary.
Material Composition: Consistent with cleared materials for similar devices.	Made from Y-TZP Zirconium Oxide (Katana Zirconia K143439), which is the same as the primary predicate.

Explanation: The acceptance criteria for this type of dental prosthetic primarily revolve around the biocompatibility and mechanical properties of the material, and its equivalence to already cleared devices. The document explicitly states that the device leverages the clearance of its material and the substantial equivalence to predicate devices, thus directly addressing these aspects rather than presenting specific numerical acceptance criteria for a new performance study.

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. No dedicated "test set" in the context of a performance study for AI/software is mentioned. The assessment relies on the properties of the material and comparison to predicate devices, not on a new clinical or observational study with a test set of data.
Data Provenance: Not applicable. The data primarily consists of the chemical composition and established properties of the ziconia material (Katana Zirconia K143439) and the characteristics of predicate devices (K153534, K071182).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study requiring human expert assessment for ground truth determination, as it's a physical dental device. The determination of "ground truth" for a physical material typically comes from standardized material testing and regulatory guidelines.

4. Adjudication method for the test set

Not applicable. There was no test set requiring adjudication in this submission.

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 is not an AI/software device. No MRMC study was conducted.

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

Not applicable. This is a physical medical device (dental bridge), not an algorithm or AI.

7. The type of ground truth used

Ground Truth: For a physical device like this, "ground truth" pertains to the established material properties (e.g., strength, biocompatibility) of the zirconium oxide, as well as the manufacturing consistency according to established quality systems. The document states the material (Katana Zirconia) is cleared for its intended use, implying its properties meet regulatory standards.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. As there is no training set mentioned or implied, the method of establishing its ground truth is irrelevant.

In summary, this 510(k) submission for the NobelProcera® HT ML FCZ Bridge is based on demonstrating the safety and effectiveness through substantial equivalence to legally marketed predicate devices and by leveraging the prior clearance of the material used. It does not present a de novo performance study with acceptance criteria in the manner one would see for an AI or software-as-a-medical-device (SaMD) product.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The symbol is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

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

November 22, 2016

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

Re: K162043

Trade/Device Name: NobelProcera® HT ML FCZ Bridge Regulation Number: 21 CFR 872.3920 Regulation Name: Porcelain Tooth Regulatory Class: Class II Product Code: ELL Dated: October 25, 2016 Received: October 26, 2016

Dear Charlemagne 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.

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

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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,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use

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

510(k) Number ( if known )	K162043
Device Name	Nobel Procera® HT ML FCZ Bridge
Indications for Use (Describe)	NobelProcera® HT ML FCZ Bridge is indicated for use as core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function.
	NobelProcera® HT ML FCZ Bridge is indicated for use as a bridge that will be cemented on natural teeth or artificial abutments.

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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
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Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)	Page 1 of 1	PSC Publishing Services (301) 443-6740	EF
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A.4. 510(k)

Summary

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: October 25, 2016

II. DEVICE

Name of Device: NobelProcera HT ML FCZ Bridge Common or Usual Name: Porcelain tooth Classification Name: Porcelain tooth (21 CFR 872.3920) Regulatory Class: II Product Code: ELL

III. PREDICATE DEVICE

Primary predicate: Nobel Biocare - NobelProcera HT ML Full Contour Zirconia Crown (K153534)

Reference predicates: Nobel Biocare - Procera Bridge Zirconia (K071182) Kuraray Noritake Dental Inc. - Katana Zirconia (K143439)

IV. DEVICEDESCRIPTION

NobelProcera®HT ML FCZ Bridge is an individualized cement retained dental restoration manufactured from translucent multi-layered zirconia material.

NobelProcera® HT ML FCZ Bridge is intended to be a replacement for a natural teeth. After finalizing the NobelProcera®HT ML FCZ Bridge in the dental laboratory, it is cemented or bonded on prepared teeth or artificial abutments by a clinician, to provide a natural tooth like appearance and to restore chewing functionality in the patient's mouth. To achieve esthetics and required value and chroma of the surrounding natural teeth the NobelProcera® HT ML FCZ Bridge is suitable for cut-back (veneering) or stain and glaze techniques.

The design of the NobelProcera® HT ML FCZ Bridge is determined in a dental laboratory, hospital or dental practice by scanning, designing and ordering the bridge using NobelDesign or supported third party CAD systems. The bridge, once ordered, is sent electronically to one of NobelProcera's centralized milling centers for fabrication.

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The NobelProcera® HT ML FCZ Bridge is manufactured from a solid piece of yitria-stabilized tetragonal zirconia. It is available in 6 shades and for bridges between 2 and 14 units.

V. INDICATIONS FOR USE

NobelProcera® HT ML FCZ Bridge is indicated for use as a bridge that is cemented on natural teeth or artificial abutments.

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Comparison of Technological Characteristics VI.

Characteristic		Candidate	Primary Predicate	Reference Predicate	Reference Predicate
		NobelProcera HT ML FCZBridge	NobelProcera HT ML FullContour Zirconia Crown(K153534)	Procera Bridge ZirconiaExtended Units(K071182)	Katana Zirconia(K143439)
Features	Material	Y-TZP Zirconium Oxide(Katana Zirconia K143439)	Y-TZP Zirconium Oxide(Katana Zirconia K143439)	Y-TZP Zirconium Oxide	Y-TZP Zirconium Oxide
	Shape	Full anatomic contour withpartial cut-back option	Full anatomic contour withpartial cut-back option	Core structure (framework)for a bridge	N/A
	DesignMethod	CAD	CAD	CAD	N/A
	ManufacturingMethod	Nobel Biocare in-houseCAM	Nobel Biocare in-house CAM	Nobel Biocare in-houseCAM	N/A
	Number ofunits	2-14 units	Individual crown	2-14 units	N/A
	MinimumThickness	0.6 mm	0.4 mm (Anterior)0.7 mm (Pre-molar and Molar)	0.6 mm	N/A
IntendedUse/Principles ofOperation		The NobelProcera HT MLFCZ Bridge is anindividualized cementretained dental restoration.It is intended to be areplacement for naturalteeth.	The NobelProcera HT ML FullContour Zirconia Crown is anindividualized cement retaineddental restoration.It is intended to be areplacement for natural teeth.	The Procera Bridge Zirconiais an individualized cementretained dental restoration.It is intended to be areplacement for natural teeth	Katana Zirconia is used forthe fabrication of the all-ceramic restorations(frameworks, FCZ crowns,FCZ bridges, inlays, onlaysand veneers.)
Indications for Use		NobelProcera HT ML FCZBridge is indicated for useas core structure of anartificial prosthesis forpartially edentulouspatients in the need ofprosthetic oralreconstruction in order torestore chewing function.NobelProcera HT ML FCZBridge is indicated for useas a bridge that iscemented on natural teethor artificial abutments.	NobelProcera HT ML FullContour Zirconia Crown isindicated for use as corestructure of an artificialprosthesis for partiallyedentulous patients in the needof prosthetic oral reconstructionin order to restore chewingfunction.NobelProcera HT ML FullContour Zirconia Crown isindicated for use as singlecrown that will be cemented toa natural or artificial toothabutment.	Nobel Biocare's ProceraBridge Zirconia is indicatedfor use as the core structureof an artificial prosthesis forpartially edentulous patientsin the need of prosthetic oralreconstruction in order torestore chewing function.The Procera Bridge Zirconiamay be cemented or bondedto either natural or artificialtooth abutments.	KATANA Zirconia is usedfor the fabrication of the all-ceramic restorations(frameworks, FCZ crowns,FCZ bridges, inlays, onlaysand veneers.)

Nobel Biocare Traditional 510(k) Notification NobelProcera HT ML FCZ Bridge 88-20196

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Analysis of Differences Between Subject Device and Predicates

The NobelProcera HT ML FCZ Bridge differs from the primary predicate NobelProcera HT ML Full Contour Zirconia Crown (K153534) in the number of units available. As a crown the primary predicate is intended only to be used on a single tooth. The subject device is a bridge intended for 2 to 14 unit restorations.

The subject device uses the same high translucent multi laver Katana material (reference predicate K143439) as the primary predicate K153534. This material is cleared for the fabrication of full contour bridges such as the subject NobelProcera HT ML FCZ Bridge. The number of units available for the subject bridges is the same as the reference predicate Procera Bridge Zirconia (K071182).

Intended Use:

The NobelProcera HT ML FCZ Bridge and primary predicate NobelProcera HT ML Full Contour Zirconia Crown have the same intended use. They are individualized cement retained dental restorations intended to be a replacement for natural teeth.

Summary:

The changes detailed above do not raise different questions of safety or effectiveness compared to the predicates.

VII. PERFO RMANCE 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 aspect of the 510(k).

patibility - Biocom
- The subject device is manufactured entirely from the zirconia cleared under o K143439. It is manufactured using the same method as the predicate (K153534). The subject device has the same intended use, patient contact type, and duration as the predicate. Therefore, no additional testing was required.

- Perform ance Data

The NobelProcera HT ML FCZ Bridge is made entirely from the Katana Zirconia o material cleared under K143439. Since this predicate material is intended to be used in the manufacture of bridge such as the subject device, no additional performance testing is necessary.

VIII. CONCLUSIONS

The NobelProcera HT ML FCZ Bridge was evaluated for substantial equivalence. Based on technological characteristics, the NobelProcera HT ML FCZ Bridge has been shown to be substantially equivalent to the NobelProcera HT ML Full Contour Zirconia Crown (K153534).

Nobel Biocare Traditional 510(k) Notification NobelProcera HT ML FCZ Bridge October 2016

Regulation Number and Section

§ 872.3920 Porcelain tooth.

(a)
Identification. A porcelain tooth is a prefabricated device made of porcelain powder for clinical use (§ 872.6660) intended for use in construction of fixed or removable prostheses, such as crowns and partial dentures.(b)
Classification. Class II.