The Straumann P.004 Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments. The devices covered in this submission are abutments.

The basal portion of the abutment has 4 grooves diametrically opposed that engage in the 4 protrusions of the P.004 implant. The abutment is seated in the implant with a screw which is mounted in the basal portion of the abutment. The abutment is used for cemented and screw-retained restorations.

AI/ML Overview

This document is a 510(k) summary for a dental abutment, demonstrating substantial equivalence to a predicate device. It does not contain information about a study with acceptance criteria and device performance in the way typically expected for a medical imaging AI device or a similar diagnostic tool where specific performance metrics like sensitivity, specificity, or accuracy are reported against a ground truth.

Instead, the document focuses on demonstrating substantial equivalence for a physical medical device (dental abutment) based on its intended use, material, fundamental operating principles, and basic design being identical or substantially equivalent to previously cleared predicate devices.

Therefore, many of the requested categories for robust clinical study data are not applicable to this type of submission.

Here's a breakdown based on the provided text, indicating where information is present versus where it is not applicable for this specific type of device and submission:

Acceptance Criteria and Device Performance Study for P.004 NC Gold Abutment for Crowns

This 510(k) submission (K072497) for the P.004 NC Gold Abutment for Crowns aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than performing a de novo clinical study with specific performance acceptance criteria for a diagnostic or AI-driven device. The "acceptance criteria" here are implicitly related to demonstrating that the new device shares the same technological characteristics and intended use as the predicate devices, and therefore can be marketed.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for substantial equivalence of a physical dental abutment and not a performance study for a diagnostic device, explicit acceptance criteria with numerical performance metrics (e.g., sensitivity, specificity, accuracy) are not reported in this document. The "performance" assessment is based on a comparison of technological characteristics and intended use to predicate devices, implying that if these are substantially equivalent, the device performs adequately for its intended use.

Acceptance Criterion (Implicit for Substantial Equivalence)	Reported Device "Performance" (Comparison to Predicate)
Intended Use Equivalence: Device intended use matches predicate.	"Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures." - Identical to predicate's stated intended use.
Material Equivalence: Material composition matches predicate.	"The intended use, material and fundamental operating principles are identical to the predicate devices."
Fundamental Operating Principles Equivalence: Device operates similarly to predicate.	"The intended use, material and fundamental operating principles are identical to the predicate devices."
Basic Design Equivalence: Device design is substantially similar to predicate.	"The basic design of the proposed abutment is substantially equivalent to the currently marketed devices."

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

Not Applicable. This submission does not describe a clinical performance study with a "test set" of patients or cases in the context of diagnostic or AI performance. The equivalence is based on the design, materials, and intended use of the device itself.

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

Not Applicable. No ground truth establishment for a test set is described as this is not a diagnostic device performance study.

4. Adjudication Method for the Test Set

Not Applicable. No adjudication method for a test set is described.

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

Not Applicable. This type of study is relevant for diagnostic performance, especially for AI algorithms, and is not applicable to the substantial equivalence determination for a physical dental abutment.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not Applicable. This refers to AI algorithm performance and is entirely irrelevant to this device submission.

7. Type of Ground Truth Used

Not Applicable. No ground truth in the context of diagnostic performance (e.g., pathology, outcomes data) is used. The "truth" for this submission is whether the device's characteristics align with those of cleared predicate devices.

8. Sample Size for the Training Set

Not Applicable. This refers to AI algorithm training data, which is not relevant to this submission.

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

Not Applicable. This refers to AI algorithm training data ground truth, which is not relevant to this submission.

Summary of the Document's Focus:

This 510(k) summary for the P.004 NC Gold Abutment for Crowns relies on the concept of substantial equivalence to predicate devices (P.004 RC Gold Abutment for Crowns, K070549, and Straumann P.004 Dental Implants, K062129). The core argument is that:

The intended use is the same.
The material is the same.
The fundamental operating principles are the same.
The basic design is substantially equivalent.

Because these critical characteristics match the predicate devices, the FDA determined that the new device can be legally marketed without requiring extensive new clinical performance data. The FDA's acceptance of the 510(k) is the "proof" that the device meets the implicit acceptance criteria for substantial equivalence.

Summary

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SEP 2 to 2007

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Section H 510(k) SUMMARY

1. Applicant's Name and Address

Straumann US (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 800-448-8168, ext 2513 978-747-0023 Fax Number: Contact Person: Elaine Alan Regulatory Affairs Specialist Date of Submission: September 4, 2007

2. Name of the Device

Trade Name:	P.004 NC Gold Abutment for Crowns
Common Name:	Abutment, Dental, Endosseous implants
Classification Name:	Abutment, Dental, Endosseous implants
	21 CFR 872.3630

3. Legally Marketed Device to which Equivalence is Claimed (Predicate Device)

P.004 RC Gold Abutment for Crowns, K070549 Straumann P.004 Dental Implants, K062129

4. Description of the Device

5. Intended Use of the Device

Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges or overdentures.

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6. Technological Characteristics

The proposed abutment is substantially equivalent to the currently marketed devices. The intended use, material and fundamental operating principles are identical to the predicate devices. The basic design of the proposed abutment is substantially equivalent to the currently marketed devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features the department's emblem, which is a stylized representation of a human figure with three arms or lines extending upwards, symbolizing health, services, and humanity. The emblem is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 6 2007

Institut Straumann AG C/O Ms. Elaine Alan Regulatory Affairs Specialist Straumann USA 60 Minuteman Road Andover, Massachusetts 01810

Re: K072497

Trade/Device Name: P.004 NC Gold Abutment for Crowns Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 4, 2007 Received: September 5, 2007

Dear Ms. Alan:

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 such 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. Alan

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sylette Y. Michaud
M.D.

Chiu Lin, Ph.D. 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 STATEMENT

Device Name: P.004 NC Gold Abutment for Crowns

Indications for Use:

Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.

Prescription Use	X
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)

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

510(k) Number:	K028492
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510(k) Submission: P.004 NC Gold Abutment for Crowns September 4, 2007 Proprietary and Confidential

Straumann US Page 5

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.)