K Number

Device Name

NobelProcera HT ML FCZ Bridge

Manufacturer

Nobel Biocare AB

Date Cleared

2016-11-22

(120 days)

Product Code

ELL

Regulation Number

872.3920

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K153534

Reference Devices

K071182, K143439

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a dental bridge manufactured from zirconia, designed using CAD systems, and fabricated in a milling center. There is no mention of AI or ML being used in the design, manufacturing, or function of the device.

Therapeutic

No
The device is a dental restoration (bridge) used to restore chewing function and provide a natural tooth-like appearance, which is primarily a restorative and prosthetic function, not a therapeutic one in the medical sense of treating a disease or condition.

Diagnostic

The device is a dental restoration (bridge) used to restore chewing function and appearance, not to diagnose a condition.

SaMD (Software as a Medical Device)

The device is a physical dental restoration (bridge) manufactured from zirconia material. While its design is determined using CAD systems, the device itself is a tangible, physical product.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to restore chewing function and provide a natural tooth-like appearance by replacing missing teeth with a bridge. This is a structural and functional restoration, not a diagnostic test performed on biological samples.
Device Description: The device is a physical dental prosthesis (a bridge) made from zirconia. It is designed to be cemented onto existing teeth or abutments.
Lack of Diagnostic Function: The device itself does not perform any diagnostic function. It does not analyze biological samples (like blood, urine, or tissue) to provide information about a patient's health status or disease.
Manufacturing Process: The process involves scanning, designing, and milling a physical object. While scanning is involved, it's for creating a model for fabrication, not for analyzing biological data.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The NobelProcera® HT ML FCZ Bridge is an in vivo device, meaning it is placed and functions within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

ELL

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dental laboratory, hospital or dental practice

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

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).

Biocampatibility - The subject device is manufactured entirely from the zirconia cleared under 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.
Performance Data - The NobelProcera HT ML FCZ Bridge is made entirely from the Katana Zirconia 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.

Key Metrics

Not Found

Predicate Device(s)

K153534

Reference Device(s)

K071182, K143439

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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

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

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
Food and Drug Administration
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.

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.

Comparison of Technological Characteristics VI.

Characteristic		Candidate	Primary Predicate	Reference Predicate
		NobelProcera HT ML FCZ
Bridge	NobelProcera HT ML Full
Contour Zirconia Crown
(K153534)	Procera Bridge Zirconia
Extended 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 with
partial cut-back option	Full anatomic contour with
partial cut-back option	Core structure (framework)
for a bridge	N/A
	Design
Method	CAD	CAD	CAD	N/A
	Manufacturing
Method	Nobel Biocare in-house
CAM	Nobel Biocare in-house CAM	Nobel Biocare in-house
CAM	N/A
	Number of
units	2-14 units	Individual crown	2-14 units	N/A
	Minimum
Thickness	0.6 mm	0.4 mm (Anterior)
0.7 mm (Pre-molar and Molar)	0.6 mm	N/A
Intended
Use/Principles of
Operation		The NobelProcera HT ML
FCZ Bridge is an
individualized cement
retained dental restoration.
It is intended to be a
replacement for natural
teeth.	The NobelProcera HT ML Full
Contour Zirconia Crown is an
individualized cement retained
dental restoration.
It is intended to be a
replacement for natural teeth.	The Procera Bridge Zirconia
is an individualized cement
retained dental restoration.
It is intended to be a
replacement for natural teeth	Katana Zirconia is used for
the fabrication of the all-
ceramic restorations
(frameworks, FCZ crowns,
FCZ bridges, inlays, onlays
and veneers.)
Indications for Use		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 is
cemented on natural teeth
or artificial abutments.	NobelProcera HT ML Full
Contour Zirconia Crown 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 Full
Contour Zirconia Crown is
indicated for use as single
crown that will be cemented to
a natural or artificial tooth
abutment.	Nobel Biocare's Procera
Bridge Zirconia is indicated
for use as the core structure
of an artificial prosthesis for
partially edentulous patients
in the need of prosthetic oral
reconstruction in order to
restore chewing function.
The Procera Bridge Zirconia
may be cemented or bonded
to either natural or artificial
tooth abutments.	KATANA Zirconia is used
for the fabrication of the all-
ceramic restorations
(frameworks, FCZ crowns,
FCZ bridges, inlays, onlays
and veneers.)

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

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