Nobel Biocare's AurAdapt™ Abutment System is a set of screw retained modifiable gold alloy abutments that are secured to an endosseous implant and are intended to function as an anchor to which prosthetic devices, such as artificial teeth, may be attached by a screw or by dental cement to restore a patient's chewing function.

Device Description

The Nobel Biocare AurAdapt™ Abutment System is a set of modifiable gold alloy abutments which are secured directly to the dental fixtures using a gold abutment screw. These abutments (also referred to as "Gold Cylinder to Fixture" abutments) can be casted into a screw retained dental prosthesis or reshaped by wax-up techniques to anchor a cemented prosthesis. When more than one of the modifiable abutments are used, a multi-unit bridge can be attached to the abutments.

AI/ML Overview

This pre-market notification for the Nobel Biocare AurAdapt™ Abutment System does not contain the detailed information necessary to complete all sections of your request. This document is a 510(k) summary submitted to the FDA in 1997 for a medical device (dental abutment system) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria in the way you've outlined for an AI/software device.

Here's an attempt to answer the questions based on the provided text, along with explanations for why certain information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance (Implied from Substantial Equivalence and Safety Concerns)
Functional Equivalence: Device performs as an anchor for prosthetic devices to restore chewing function.	"The technological characteristics between the components of the AurAdapt Abutment System and the corresponding predicate products found in the Branemark System® are identical." (Implies similar functional performance). However, no specific performance metrics (e.g., success rates, failure rates) are provided.
Material Compatibility: Gold alloy abutments are suitable for use in the oral cavity and interface with titanium implants.	Implied by "modifiable gold alloy abutments" and "secured directly to the dental fixtures." No specific material compatibility test results are presented.
Mechanical Integrity (Screws): Abutment screws remain secure under masticatory forces and avoid fracture.	Safety Concern Identified: "occasional fractures of the screw attaching the abutment to the fixtures usually due to functional overload from masticastory forces" and "loose (usually because torque force below recommended values was applied...)" (This indicates areas where performance could be compromised, but no established acceptance criteria or empirical performance data is given for the new device against these concerns).
Proper Seating: Abutments seat correctly without causing inflammation.	Safety Concern Identified: "improper seating of abutments resulting in gingival initial inflammation and fistulae formation." (Again, a concern, not an acceptance criterion with associated performance data for the new device).
Biocompatibility: Materials are biocompatible.	Not explicitly stated, but assumed for dental devices. No specific biocompatibility study results are mentioned.

Explanation for Table: The document's primary purpose is to establish substantial equivalence. It highlights the intended use and technological characteristics being identical to predicate devices. It then lists "Safety and Effectiveness Concerns" encountered with similar abutment systems, which represent potential failure modes but are not presented as acceptance criteria for the new device, nor is there corresponding performance data for how the AurAdapt™ Abutment System specifically addresses or performs against these concerns. This type of submission does not typically include a detailed performance study with explicit acceptance criteria and corresponding results in the format you've requested.

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

Not Applicable. The document does not describe a performance study with a test set of data in the context of an AI/software device. It's a submission for a physical medical device.

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)

Not Applicable. See point 2. No test set requiring expert ground truth is described.

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

Not Applicable. See point 2.

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

Not Applicable. This device is a physical dental abutment system, not an AI or imaging diagnostic tool that would typically undergo MRMC studies.

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

Not Applicable. This is a physical device, not an algorithm.

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

Not Applicable. See point 2.

8. The sample size for the training set

Not Applicable. This is a physical device, not an AI or software algorithm that uses a training set.

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

Not Applicable. See point 8.

Summary

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472475

Pre-market Notification Page -3-..............................................................................................................................................................................

SEP 1 2 1997

510(k) Summary of Safety and Effectiveness VII.

A. Name and Address

This Summary of Safety and Effectiveness is being submitted by Nobel Biocare USA, Inc., 777 Oakmont Lane, Suite 100, Westmont, IL 60559. The telephone number is: (630) 654-9100, extension 2002, and the contact person will be Betsy Brown, the Vice President, Regulatory Affairs.

B. Name of the Device

· This device system consists of various modifiable gold alloy abutments, abutment screws, a counter torque device with handle, adaptors, machine Uni-grip screwdrivers with autoclavable box, temporary cylinders, temporary tubes, laboratory screws and impression copings.

C. The Predicate Product

The predicate products used in this Pre-market Notification are similar components marketed by Nobel Biocare including the UCLA - Type Abutments (K934495), CeraOne™ Abutment Screw (K961737), Guide Pin (K911969), Abutment Lab-Screw (K925769), CerAdapt™, Machine Counter Torque Device (K953775), EsthetiCone Temporary Cylinder (K925766), Miruscone Temporary Cylinder (K962403), Temporary Tube (K926766), Titanium Impression Coping (K952448), Plastic Impression Coping (K910611), CeraOne™ Screwdrivers (K922805) and Fixture Guide Set Tray (K944963).

D. Description of Device

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E. Intended Use of the Device

F. Comparison of Technological Characteristics
· The technological characteristics between the components of the AurAdapt Abutment System and the corresponding predicate products found in the Branemark System® are identical.

Summary Of Safety And Effectiveness Concerns

Safety and effectiveness problems that have been encountered with similar Abutment Systems used with endosseous implants that are currently being marketed include:

1. occasional fractures of the screw attaching the abutment to the fixtures usually due to functional overload from masticastory forces;
loose (usually because torque force below 2. screws working recommended values was applied when the abutment was attached to the fixture) may lead to the formation of granulation tissue at the level of the fixture and abutment connection which may, in turn, result in infection;
seating of abutments resulting in gingival initial 3. improper inflammation and fistulae formation, both conditions resolve when proper seating of the abutment is accomplished.
occasional fracture of the abutment screw which is usually caused by বা poorly designed and/or fabricated restorations that creates overloads or cause's metal fatigue.

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

SEP 1 7 2010

Ms. Phuong Nguven Son Regulatory Affairs Manager Nobel Biocare USA, LLC 22715 Savi Ranch Parkway

Re: K972475

Trade/Device Name: Auradapt Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 28, 2010 Received: July 29, 2010

Dear Ms. Nguyen Son:

This letter corrects our substantially equivalent letter of July 28, 2010.

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 (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- Ms. Nguyen 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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

&
Susan Ruome
Anthony D. 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

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510(k) Number (if known):	K972475
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AurAdapt Abutment System Device Name:

Indications For Use:

Nobel Biocare's AurAdapt Abutment System is a set of screw retained modifiable gold alloy abutments which are secured to an endosseous implant and is intended to function as an anchor to which prosthetic devices, such as artificial teeth, may be attached using dental cement to restore a patient's chewing function.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED

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Prescription Use ﮯ (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.)