The Nobel Biocare PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.

Device Description

NobelProcera PEEK Abutments are endosseous dental implant abutments. They are made from PEEK in natural color or white. The PEEK Abutments are available in a variety of preformed and customized shapes that can be used either as provisional abutments or as healing abutments. The customized PEEK Abulments must be straight, further design limitations for customized shapes are given in the Instructions for Use.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the NobelProcera PEEK Abutments:

Acceptance Criteria and Study Analysis for NobelProcera PEEK Abutments (K120954)

1. Table of Acceptance Criteria and Reported Device Performance:

The provided documentation does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) for the NobelProcera PEEK Abutments. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices. This equivalence is based on a comparison of characteristics rather than performance metrics from a clinical study.

Characteristic	Acceptance Criterion (Implied by Predicate)	Reported Device Performance (NobelProcera PEEK Abutments)
Material	PEEK	PEEK
Color	Natural (Branemark) / White (Neo Implant)	Natural & White
Attachment Method	Screw retained; Engaging & Non Engaging	Screw retained; Engaging & Non Engaging
Intended Use	Healing abutment (Neo Implant), Provisional abutment (Both)	Healing abutment, Provisional abutment
Duration of Use	90 days (Branemark) / 180 days (Neo Implant)	180 days
Implant/Abutment Connection	Nobel Biocare - External Hex, Internal Conical, Internal Tri-lobe (Branemark) / Neoss - Internal Hex (Neo Implant)	Nobel Biocare - External Hex, Internal Conical, Internal Tri-lobe
Abutment Profile	Straight walled; Various anatomical shapes	Provisional: Straight walled or designed with Procera system; Healing: Various anatomical shapes or individually designed with Procera system
Biocompatibility	Demonstrated in predicate devices	Performed following ISO 10993 (Cytotoxicity: ISO 10993-5)
Sterilization	Demonstrated in predicate devices	Performed in accordance with ISO 17665

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

No clinical test set was used to demonstrate safety and effectiveness. The submission explicitly states: "No Clinical test data was used to support the decision of safety and effectiveness."
Instead of a clinical test set, the device's equivalence was established through non-clinical testing (biocompatibility and sterilization) and a comparison of device characteristics to predicate devices already on the market.

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

Not applicable. As no clinical test data was used, there was no "ground truth" established by experts for a test set in the context of device performance. The assessment was based on comparing material properties, design, and indications for use against predicate devices.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring expert adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. An MRMC study was not conducted as no clinical studies involving human readers or assessment of AI performance were performed. This device is a dental implant abutment, not an AI/imaging diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

No. This is a physical medical device (dental abutment), not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used:

Implied Regulatory Ground Truth: The "ground truth" in this context is the regulatory acceptance of the predicate devices. The new device is deemed safe and effective because its characteristics (material, design, intended use, non-clinical performance) are substantially equivalent to devices that have already demonstrated safety and effectiveness and are legally marketed.
For non-clinical tests (biocompatibility, sterilization), the ground truth is established by the standards themselves (ISO 10993, ISO 17665), where meeting the parameters of these standards indicates acceptable performance.

8. Sample Size for the Training Set:

Not applicable. This device does not involve a training set as it is not an AI or machine learning model.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set for this device, ground truth establishment for it is irrelevant.

Summary

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K120954

1.4 510(k) Summary

5 2013 JUN

Submitted by:	Phuong Nguyen SonRequlatory Affairs Manager
Address:	Nobel Biocare USA LLC22715 Savi Ranch ParkwayYorba Linda, CA 92887
Telephone:	(714) 282-4800 ext 7830
Facsimile:	(714) 998-9348
Date Prepared:	4 June, 2013
Classification Name:	Endosseous Dental Implant Abutment (21 CFR 872.3630)
Product Code:	NHA
Trade or Proprietaryor Model Name:	NobelProcera PEEK Abutments
Legally Marketed Device(s):	Brånemark System Temporary Solutions (K925766)Neo Implant System (K043195)

Device Description:

NobelProcera PEEK Abutments are endosseous dental implant abutments. They are made from PEEK in natural color or white. The PEEK Abutments are available in a variety of preformed and customized shapes that can be used either as provisional abutments or as healing abutments. The customized PEEK Abutments can be shaped to follow the contour of the tissue intended to surround the definitive abutment. Customized PEEK Abulments must be straight, further design limitations for customized shapes are given in the Instructions for Use.

Indications for Use:

Non-Clinical Testing:

Non-clinical testing was performed to support the decision of safety and effectiveness. Non-clinical testing consisted of Biocompatibility testing following ISO 10993. Cytotoxicity testing using the ISO Elution Method (ISO 10993-5) was performed. Also sterilization in accordance with ISO 17665 was performed.

Clinical Testing:

No Clinical test data was used to support the decision of safety and effectiveness.

Conclusions:

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

Nobel Biocare 510(k) Notification NobelProcera PEEK Abutments March 2012

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510(k) Summar 1.4

Substantial Equivalence Comparison to Predicate Device

CHARACTERISTIC	CANDIDATENobelProcera PEEK Abutments	PREDICATEBrånemark System TemporarySolutions(K925766)	PREDICATENeo Implant System*(K043195)
Material	Polyetheretherketone (PEEK)	Polyetheretherketone (PEEK)	Polyetheretherketone (PEEK)
Color	Natural & White	Natural	White
Attachment Method	Screw retainedEngaging & Non Engaging	Screw retainedEngaging & Non Engaging	Screw retained
Intended Use	Healing abutmentProvisional abutment	Provisional abutment	Healing abutmentProvisional abutment
Duration of Use	180 days	90 days	180 days
Implant/AbutmentConnection	Nobel Biocare- External Hex- Internal Conical- Internal Tri-lobe	Nobel Biocare- External Hex- Internal Conical- Internal Tri-lobe	Neoss- Internal Hex
Abutment Profile	Provisional abutments - Straight walledor designed with Procera system- Healing Abutments - Variousanatomical shapes intended fordifferent tooth locations or individuallydesigned with Procera system	Straight walled	Provisional abutments - Straight walled- Healing Abutments - Variousanatomical shapes intended for differenttooth locations

This predicate contains a full implant system including provisional and anatomical healing abutments made of PEEK. This 510(k) is only using these
abutments as a predicate

K120954

Nobel Biocare Traditional 510(k) Notification
NobelProcera PEEK Abutments
March 2012

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings, positioned to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird-like figure.

Public Health Service

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

June 5, 2013

Nobel Biocare AB C/O Ms. Phuong Nguyen Son Regulatory Affairs Manager Nobel Biocare USA, Limited Liability Company 22715 Savi Ranch Parkway YORBA LINDA CA 92887

Re: K120954

Trade/Device Name: NobelProcera PEEK Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 20, 2013 Received: May 21, 2013

Dear Ms. Son:

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,-1.976, 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. Son

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 (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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.

Sincerely vours,

Susan Runner DESIGNS Mary S. Runner

Kwame Ulmer, M.S. Acting Division 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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Indications for Use

K120954 510(k) Number (if known):

Device Name: NobelProcera PEEK Abutments

Indications For Use:

The Nobel Blocare PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental Implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.

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)

Andrew I. Steen 2013.06.05 08:44:23 04'00'

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

510(k) Number:

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.)