The NobelProcera® HT ML FCZ (full contour zirconia) and framework Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

Device Description

The NobelProcera HT ML FCZ Implant Bridge and Framework is an individualized implant supported screw-retained dental implant bridge for the partially dentate and edentulous patients. The NobelProcera HT ML FCZ Implant Bridge and Framework is available as either a framework requiring veneering in a dental lab or as a full anatomic contour design requiring minimum laboratory processing. The NobelProcera HT ML FCZ Implant Bridge and Framework is available for bridges between 2 to 14 units. The bridge is made of a titanium base and a highly transparent multi layered zirconia material which is available in 6 shades. The NobelProcera HT ML FCZ Implant Bridge and Framework is available for the Nobel Biocare internal conical connection, external hex, and internal tri-channel implants and the Multi-unit abutments.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the NobelProcera HT ML FCZ Implant Bridge and Framework:

The document is a 510(k) premarket notification summary for a dental implant bridge and framework. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device with performance criteria requiring a complex clinical study. Therefore, many of the requested categories (like MRMC studies, ground truth for training sets, etc.) are not applicable or not detailed in this type of submission.

Acceptance Criteria and Study for NobelProcera HT ML FCZ Implant Bridge and Framework

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance and Methodology
Fatigue Limit	• Must demonstrate equivalent or superior fatigue strength compared to the predicate device.• Must withstand likely worst-case clinical use conditions.	• Tested using a modified version of ISO 14801. • Modifications were made to reflect "likely worst-case clinical use." • Both the subject device (NobelProcera HT ML FCZ Implant Bridge and Framework) and the predicate device (NobelProcera Implant Bridge Zirconia - K091907) were tested under "identical conditions." • The results were used to address questions of substantial equivalence based on design differences. (Specific numerical results for fatigue limits are not provided in this summary.)
Sterilization	• Must be validated according to relevant ISO standards.	• Validation of recommended sterilization parameters was conducted according to ISO 17665-1 and ISO 17665-2.
Biocompatibility	• Must not exhibit cytotoxicity.• Must not release harmful leachables/extractables.	• Cytotoxicity testing was performed according to ISO 10993-5. • BC-MS (Biocompatibility-Mass Spectrometry?) analysis for leachables/extractables was conducted. • These tests were performed on the ISO 6872 ceramic and ASTM F136 titanium alloy material composition of the device.

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

Sample Size for Fatigue Testing: Not explicitly stated. The document mentions "the subject and predicate device were tested," implying a comparative, laboratory-based study. However, the number of units tested for fatigue is not given.
Data Provenance: The studies were laboratory-based performance tests, not human data. The exact location of the testing laboratories is not specified, but the manufacturer (Nobel Biocare AB) is based in Sweden, and the submission is from their US entity.

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

This question is not applicable as the studies conducted were performance testing of the device's physical properties and biocompatibility, not studies involving human interpretation or clinical outcomes requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as (3).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical data was used to support the decision of substantial equivalence." This type of study would involve human readers (e.g., dentists, prosthodontists) evaluating cases with and without the device, which was not performed or submitted.

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 implant bridge and framework, not an algorithm or AI system.

7. The Type of Ground Truth Used

This question is not applicable in the traditional sense for these types of engineering and biocompatibility tests. The "ground truth" for these tests would be the established scientific and engineering principles and the specified values/limits within the ISO standards themselves. For example, for fatigue, the "truth" is the device's actual fatigue life as measured objectively under controlled conditions, compared against the predicate's measured fatigue life and relevant industry standards.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" as this is a physical medical device undergoing performance testing, not an AI/ML algorithm development.

9. How the Ground Truth for the Training Set was Established

This question is not applicable for the same reasons as (8).

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 features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

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

July 25, 2016

Nobel Biocare AB % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda. California 92887

Re: K160158

Trade/Device Name: NobelProcera HT ML FCZ Implant Bridge and Framework Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 14, 2016 Received: June 15, 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.

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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,

Image /page/1/Picture/8 description: The image shows a signature with the name "Tina Kiang" written above the letter "S". The signature is written in black ink and is on a white background. The signature is stylized and difficult to read.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use		Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
510(k) Number (if known)	K160158
Device Name	NobelProcera HT ML FCZ Implant Bridge and framework
Indications for Use (Describe)	The NobelProcera® HT ML FCZ (full contour zirconia) and framework Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
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 ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@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)JUNE 2016	Page 1 of 1
	PSC Publishing Services (301) 443-6740 EFK160158-S001Page 25 of 412

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A.4.

510(k) Summary

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 15, 2016

II. DEVICE

Name of Device: NobelProcera HT ML FCZ Implant Bridge and Framework Common or Usual Name: Endosseous Dental Implant Abutment Classification Name: Endosseous Dental Implant Abutment (21 CFR 872.3640) Requlatory Class: II Product Code: NHA

III. PREDICATE DEVICE

Nobel Biocare - NobelProcera Implant Bridge Zirconia (K091907) Nobel Biocare -Angulated Screw Channel Abutment Conical Connection (K132746)

IV. DEVICE DESCRIPTION

The NobelProcera HT ML FCZ Implant Bridge and Framework is an individualized implant supported screw-retained dental implant bridge for the partially dentate and edentulous patients.

The NobelProcera HT ML FCZ Implant Bridge and Framework is available as either a framework requiring veneering in a dental lab or as a full anatomic contour design requiring minimum laboratory processing. The NobelProcera HT ML FCZ Implant Bridge and Framework is available for bridges between 2 to 14

Nobel Biocare Traditional 510(k) Notification NobelProcera HT ML FCZ Implant Bridge and Framework July 2016

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units. The bridge is made of a titanium base and a highly transparent multi layered zirconia material which is available in 6 shades.

The NobelProcera HT ML FCZ Implant Bridge and Framework is available for the Nobel Biocare internal conical connection, external hex, and internal tri-channel implants and the Multi-unit abutments.

V. INDICATIONS FOR USE

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

Technologicalcharacteristics		Subject Device	Predicate
		NobelProcera HT ML FCZImplant Bridge and Framework	NobelProcera Implant Bridge Zirconia(K091907)
Design Features	CompatibleImplant/AbutmentPlatform	Nobel BiocareInternal Conical Connection NP, RP, WPInternal Tri-Channel NP, RP, WP, 6.0External Hex NP, RP, WPMulti-unit NP/RP, WP	Nobel BiocareInternal Conical Connection NP, RP, WPInternal Tri-Channel NP, RP, WP, 6.0External Hex NP, RP, WPMulti-unit NP/RP, WP
			Astra TechYellow, Aqua, Lilac
			StraumannOctagon 3.5, 4.8, 6.5Bone Level 3.3, 4.1/4.8
			Biomet 3iInternal 3.4, 3.75/4.0, 5.0, 6.0External 3.4, 4.1, 5.0, 6.0
			ZimmerScrew-Vent 3.5, 4.5, 5.7AdVent 4.5
	Device Material	Zirconium Oxide with titanium vanadium alloy implantinterface for Internal Conical Connection.	Zirconium Oxide
	Bridge Design	Individualized full anatomic contour or framework	Individualized framework
	Arc Length	2 to 14 units	2 to 14 units
	Design method	CAD	Wax-up or CAD design

Nobel Biocare Traditional 510(k) Notification NobelProcera HT ML FCZ Implant Bridge and Framework July 2016

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Technologicalcharacteristics	Subject Device	Predicate
Manufacturingmethod	NobelProcera HT ML FCZImplant Bridge and Framework	NobelProcera Implant Bridge Zirconia(K091907)
	Industrialized manufacturing at NobelProceramanufacturing facility	Industrialized manufacturing at NobelProceramanufacturing facility

Intended use	The NobelProcera HT ML FCZ Implant Bridge andFramework are customized dental implant bridgesintended to restore chewing functions. The ImplantBridge is intended to directly attaches to the endosseousdental implants and/or onto Nobel Biocare's Multi-unitAbutments with clinical screws and provides a platformfor restoration.	The NobelProcera Implant Bridge Zirconia is a bridgeframework that attaches to implants or abutments. TheNobelProcera Implant Bridge Zirconia is intended to befinished into a dental prosthesis using standard laboratorydental materials such as resin composite or porcelainveneer.






Indication for Use	The NobelProcera® HT ML FCZ (full contour zirconia)and framework Implant Bridge are indicated for use as abridge anatomically shaped and/or framework in thetreatment of partially or totally edentulous jaws for thepurpose of restoring chewing function.	The NobelProcera Implant Bridge Zirconia is indicated foruse as a bridge framework in the treatment of partially ortotally edentulous jaws for the purpose of restoringchewing function.

The difference in the Indications for Use is the addition of the term "bridge anatomically shaped" allows for an anatomically shaped bridge as compared to just a bridge framework in the primary predicate device. The addition of an anatomically shaped bridge does not change the intended use of the implant bridge dental abutment device.

The additional difference between the subject device and the primary predicate is the inclusion of a titonia material and the implant body. The reference predicate (K132746) supports the addition of a titanium interface between the zirconia material and the implant body.

Nobel Biocare Traditional 510(k) Notification NobelProcera HT ML FCZ Implant Bridge and Framework July 2016

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VII. PERFORMANCE DATA

The fatique limit of the NobelProcera HT ML FCZ Implant Bridge and Framework 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.

Validation of the recommended sterilization parameters was conducted according to ISO 17665-1 and ISO 17665-2.

Cytotoxicity testing according to ISO 10993-5 as well as BC-MS analysis for leacables/extractable was conducted on the ISO 6872 ceramic and ASTM F136 titanium alloy material composition of the device.

No clinical data was used to support the decision of substantial equivalence.

VIII. CONCLUSIONS

The NobelProcera HT ML FCZ Implant Bridge and Framework was evaluated for substantial equivalence using standard and/or comparative testing. Based on technological characteristics and non-clinical test data included in this submission, the NobelProcera HT ML FCZ Implant Bridge and Framework has been shown to be substantially equivalent to the NobelProcera Implant Bridge Zirconia.

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.)