The NobelProcera Ti Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

Device Description

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

Nobel Biocare's NobelProcera Ti Abutments are designed and made individually to fit the individual requirements for each patient. The NobelProcera Ti Abutments are made entirely of titanium or titanium/vanadium alloy.

AI/ML Overview

The provided text is a 510(k) summary for the NobelProcera Ti Abutment. This type of regulatory submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through a clinical study or performance testing that would typically generate the kind of data requested in the prompt.

The document discusses device description, indications for use, and a comparison with legally marketed predicate devices to establish substantial equivalence. It does not contain information on acceptance criteria for device performance, nor does it detail a study performed to meet such criteria. Therefore, most of the requested fields cannot be extracted from this document.

Here's a breakdown of what can be extracted and what information is missing:

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

Missing. The document does not specify any acceptance criteria for device performance or provide reported performance metrics. The 510(k) process for this type of device (dental implant abutment) relies on demonstrating substantial equivalence to previously cleared devices, often through mechanical testing, biocompatibility, and material equivalence, rather than clinical performance metrics found in the prompt's context (like sensitivity, specificity, or reader improvement with AI).

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

Missing. No test set or study data of this nature is mentioned.

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):

Missing. This information is relevant for studies involving human interpretation or expert-driven evaluations, which are not detailed here.

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

Missing. Similar to the above, this would be relevant for expert-based evaluations, which are not described.

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:

Missing. This type of study (MRMC, AI assistance) is not applicable to an endosseous dental implant abutment and is not mentioned in the document.

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

Missing. Not applicable to this device type.

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

Missing. No "ground truth" as typically defined in diagnostic performance studies is applicable or mentioned. The device's safety and effectiveness are established through reference to predicate devices and material/design specifications.

8. The sample size for the training set:

Missing. No training set for an algorithm is mentioned.

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

Missing. Not applicable.

Summary based on the provided document:

The provided 510(k) summary for the NobelProcera Ti Abutment focuses on demonstrating substantial equivalence to predicate devices already on the market. It confirms the device's indications for use and its material composition. The document does not contain any information about acceptance criteria or performance studies (like those involving AI, human readers, or diagnostic metrics) as typically discussed for software as a medical device or diagnostic imaging devices. The type of information requested (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies) is not usually found in a 510(k) for a mechanical dental prosthetic component like an abutment.

Summary

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SEP 2 2 2009

K091756

510(k) Summary of Safety and Effectiveness 1.4

Submitted by:	Herbert Crane, Director Global Regulatory Affairs
Address:	Nobel Biocare USA LLC22715 Savi Ranch ParkwayYorba Linda, CA 92887
Telephone:	(714) 282-4800, ext. 5074
Facsimile:	(714) 998-9348
Date of Submission:	June 12, 2009
Classification Name:	Endosseous Dental Implant Abutment (21 CFR 872.3630)
Trade or Proprietaryor Model Name:	NobelProcera Ti Abutment
Legally Marketed Devices:	Nobel Biocare - Procera ® Abutment Brånemark (K042658)Nobel Biocare - Procera ® Implant Bridge Overdenture (K090064)Nobel Biocare - SFB and CFB Angled Abutments (K062749)

Device Description:

Indications for Use:

The NobelProcera Ti Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

Nobel Biocare Traditional 510(k) Notification NobelProcera Ti Abutment (additional platforms) June 2009

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized image of three overlapping shapes that resemble an abstract caduceus.

SEP 2 2 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - 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

Re: K091756

Trade/Device Name: NobelProcera Ti Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 12, 2009 Received: June 25, 2009

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.

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 (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 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/Reporta Problem/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,

h fo

Susan Runner, D.D.S., M.A. Acting 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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K091756

Indications for Use

1.3

510(k) Number (if known):

Device Name: NobelProcera Ti Abutment

Indications For Use:

The NobelProcera Ti Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

Prescription Use X … (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)

Re-Mulin for MSR

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

Page 1 of 1

510(k) Number: K091756

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.)