The NobelProcera Zi Abutments Thommen Platforms are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the Thommen Medical SPI 3.5, 4.0, 4.5, 5.0, and 6.0 implants.

Device Description

Nobel Biocare's NobelProcera Zi Abutment Thommen Platforms is an endosseous dental implant abutment. The abutment attaches directly to Thommen dental implants and provides a platform for restoration.

Nobel Biocare's NobelProcera Zi Abutments are designed and made individually to fit the individual requirements for each patient. The NobelProcera Zi Abutments are made entirely of zirconium oxide.

The abutments fit the Thommen SPI implant systems platform 3.5, 4.0, 4.5, 5.0, 6.0.

AI/ML Overview

The NobelProcera Zi Abutment Thommen Platforms device did not undergo clinical testing and therefore does not have traditional acceptance criteria based on performance metrics like sensitivity or specificity. Instead, the testing focused on validating the device's mechanical integrity and substantial equivalence to existing predicate devices.

Here's a breakdown of the available information:

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

Acceptance Criteria	Reported Device Performance
Mechanical Integrity: Withstand fatigue testing in accordance with FDA guidance for Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.	Fatigue testing was performed on "worst-case samples" and supported the decision of safety and effectiveness, implying the device met the criteria.
Substantial Equivalence: Demonstrate equivalence in design, anatomical site, platform compatibility, and indications for use compared to legally marketed predicate devices.	The submission concluded that the device is substantially equivalent to the predicate devices (NobelProcera Ti Abutment Thommen Platforms (K101714), Thommen Medical AG - SPI Easy 4.0 Abutment (K071457), and Thommen Medical AG - SPI Dental Implant Abutments (K031747)).
Biocompatibility: Utilize zirconium oxide, a material considered acceptable for medical devices.	The device is made entirely of zirconium oxide, implying its biocompatibility is assumed to be equivalent or acceptable based on material properties.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document mentions "worst-case test samples" for fatigue testing. The exact number of samples is not specified.
Data Provenance: The testing was "non-clinical test data," indicating laboratory or engineering testing. The country of origin and whether it was retrospective or prospective is not specified, though it would typically be conducted by the manufacturer in a controlled lab setting (prospective in that context).

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 did not involve human interpretation or diagnostic assessment. Therefore, there were no experts used to establish ground truth in the traditional sense of medical image analysis or clinical outcomes. The "ground truth" for mechanical testing would be the engineering specifications and performance expectations outlined in the FDA guidance document.

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

Since the testing was non-clinical and focused on mechanical performance, there was no adjudication method involving human experts for a test set. The evaluation would have been based on established engineering and materials science principles.

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 MRMC comparative effectiveness study was done. This device is a dental implant abutment, not an AI-powered diagnostic tool.

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

This question is not applicable as the device is a physical dental implant component, not an algorithm.

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

For the non-clinical testing, the "ground truth" was based on engineering specifications and performance requirements as outlined in the FDA guidance document: "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." This guidance provides the standards for fatigue and other mechanical tests.

8. The sample size for the training set

This question is not applicable as the device is a physical medical device and does not involve machine learning or a training set.

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

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

Summary

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K110171

JUN 15 2011

510(k) Summary of Safety and Effectiveness 1.4

Submitted by:	Herbert CraneDirector, Global Regulatory Affairs
Address:	Nobel Biocare USA LLC22715 Savi Ranch ParkwayYorba Linda, CA 92887
Telephone:	(714) 282-5074
Facsimile:	(714) 998-9348
Date of Submission:	January 13, 2011
Classification Name:	Endosseous Dental Implant Abutment (21 CFR 872.3630)
Trade or Proprietaryor Model Name:	NobelProcera Zi Abutment Thommen Platforms
Legally Marketed Devices:	Nobel Biocare - NobelProcera Ti Abutment Thommen Platforms(K101714)Thommen Medical AG - SPI Easy 4.0 Abutment (K071457)Thommen Medical AG - SPI Dental Implant Abutments (K031747)

Device Description

Nobel Biocare's NobelProcera Zi Abutment Thommen Platforms is an endosseous dental implant abutment. The abutment attaches directly to Thommen dental implants and provides a platform for restoration.

Nobel Biocare's NobelProcera Zi Abutments are designed and made individually to fit the individual requirements for each patient. The NobelProcera Zi Abutments are made entirely of zirconium oxide.

The abutments fit the Thommen SPI implant systems platform 3.5, 4.0, 4.5, 5.0, 6.0.

Indications for Use

Technical Modifications of Predicate Device

The NobelProcera Zi Abutment for the Thommen Platform differs from the predicates by using the material zirconium oxide.

Nobel Biocare Special 510(k) Notification NobelProcera Zi Abutments Thommen Platforms January 2011

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Summary of testing to demonstrate safety and effectiveness

Non-clinical test data was used to support the decision of safety and effectiveness. Clinical testing was not necessary. Non-clinical testing consisted of analysis of platforms to identify worst-case test samples and performance of fatigue testing of the worst-case samples in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.

Conclusion

The information provided in this submission demonstrates that the device is substantially_ equivalent to the predicate devices.

Nobel Biocare Special 510(k) Notification NobelProcera Zi Abutments Thommen Platforms January 2011

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ubstantial Equivalence Comparison to Predicate Devices

ATTRIBUTE	CANDIDATE	PREDICATE	PREDICATE
Design/Construction	NobelProcera ZiAbutmentThommen Platforms	NobelProcera Ti AbutmentThommen Platforms(K101714)	Thommen Medical AGSPI Dental Implant Abutments(K031747)
AnatomicalSite	Patient specific / machined	Patient specific / machined	Patient specific / machined
PlatformCompatibility	Oral Cavity	Oral Cavity	Oral Cavity
DeviceMaterial	ThommenSPI implant systems platform3.5, 4.0, 4.5, 5.0, 6.0	ThommenSPI implant systems platform3.5, 4.5, 5.0, 6.0	ThommenSPI implant systems platform3.5, 4.5, 5.0, 6.0
Indications forUse	Zirconium Oxide	CP TitaniumTitanium/vanadium alloyThe NobelProcera Ti AbutmentsThommen Platforms arepremanufactured prostheticcomponents directly connected toendosseous dental implants andare intended for use as an aid inprosthetic rehabilitation. They arecompatible with the ThommenMedical SPI 3.5, 4.0, 4.5, 5.0, and6.0 implants.	CP TitaniumThe Thommen SPI Easy 4.0Abutment is intended to be usedin conjunction with SPI Systemdental implants in the maxillaryand/or mandibular arch toprovide support for crowns,bridges or overdentures.	CP TitaniumThe Thommen SPI Dental ImplantAbutments are intended to beused in conjunction with SPISystem dental implants in themaxillary and/or mandibular archto provide support for crowns,bridges or overdentures.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

Nobel Biocare AB C/O Mr. Herbert Crane Director, Global Regulatory Affairs Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887

JUN 1 5 2011

Re: K110171

Trade/Device Name: NobelProcera Zi Abutment Thommen Platforms Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 13, 2011 Received: May 16, 2011

Dear Mr. Crane:

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 - Mr. Crane

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

Sincerely yours,

for

Anthony Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

KIIO17 | 510(k) Number (if known):

Device Name: NobelProcera Zi Abutment Thommen Platforms

Indications For Use:

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert S. Betz, DDS for Dr. Susan Runner

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

Page 1 of 1

510(k) Number: K110171

000020

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.)