Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. The subject abutments are for permanent screw-retained bridges and bar-retained implant-borne dentures.

Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months.

Copings are intended to serve as a base for multi-unit bar or bridge restorations.

Temporary Copings are intended to serve as a base for temporary restorations for up to 6 months.

Device Description

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.

Abutments are placed into dental implants to provide support for prosthetic restorations, copings for bars and bridges are used as a base for bar and bridge constructions, temporary copings support a temporary restoration out of occlusion and protective caps protect the abutment during the healing phase.

AI/ML Overview

This 510(k) summary for the Straumann P.004 RC/NC Bar and Bridge Abutment Line does not contain the detailed information necessary to answer your questions about acceptance criteria and study design.

This document is a regulatory submission demonstrating substantial equivalence to previously cleared devices, not a detailed technical report of performance testing against specific acceptance criteria.

Here's why I cannot provide the requested information and what is available in the provided text:

What the document does state:

Device Description: The Straumann P.004 Dental Implant System, including abutments, copings, and protective caps.
Intended Use: For supporting prosthetic restorations (crowns, bridges, overdentures) in single or multiple tooth restorations, as bases for bar/bridge constructions, and for temporary restorations or soft tissue protection.
Technological Characteristics: Claims substantial equivalence to predicate devices in material composition, basic design, and fundamental operating principles.
Predicate Devices: A list of previously cleared Straumann devices to which equivalence is claimed.

Why the requested information is NOT in the document:

The provided text (a 510(k) summary) focuses on demonstrating "substantial equivalence" to existing, legally marketed devices. For this type of submission, the manufacturer typically highlights:

Similarities in intended use.
Similarities in technological characteristics (materials, design, operating principles).
Performance data (if any significant differences exist or if new performance claims are made) is usually summarized or referenced, but the detailed study methodology, acceptance criteria, ground truth, and reader studies are rarely included in the brief summary itself. These details would be in a more comprehensive technical report or testing documentation (e.g., design control documents, test reports) that is part of the full 510(k) submission, but not typically released publicly in this summary format.

Therefore, I cannot populate the table or provide specific answers for most of your questions based solely on the provided text.

Here is a description of why each requested point cannot be answered from the provided text:

A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document does not list any specific quantitative acceptance criteria (e.g., tensile strength, fatigue life, dimensional accuracy) or the results from performance studies against such criteria. It generally states that the device has "the same material composition, basic design and fundamental operating principles" as predicate devices, implying performance is equivalent, but without specific metrics.
Sample size used for the test set and the data provenance:
- Cannot be provided. No specific performance studies with test sets are described. The submission relies on equivalence to predicate devices rather than novel performance data requiring a test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Cannot be provided. Since no specific test set or performance evaluation study (like a clinical study or even a detailed phantom study) is described in the summary, there's no mention of experts establishing ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Cannot be provided. No test set or expert evaluation process is described.
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 mechanical dental implant component, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Cannot be provided. No ground truth is mentioned because no specific performance study requiring it is described in the summary.
The sample size for the training set:
- Not applicable. This device is a physical product, not an AI algorithm requiring a training set.
How the ground truth for the training set was established:
- Not applicable. As above, no training set for an algorithm is involved.

In summary, the provided 510(k) summary is a regulatory declaration of equivalence, not a detailed scientific paper describing performance studies and acceptance criteria. To get the information you're asking for, you would typically need to review the full technical documentation supporting the original 510(k) submission, which is generally not publicly available in this level of detail.

Summary

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K080239

Section I 510(k) SUMMARY

APR 3 0 2008

1. Applicant's Name and Address

Straumann US (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 978-747-2513 Fax Number: 978-747-0023 Contact Person: Elaine Alan Regulatory Affairs Specialist

Date of Submission:

2. Name of the Device

Trade Name: Common Name: Classification Name: Regulation Number:

P.004 RC/NC Bar and Bridge Abutments Line Abutment, Dental, Endosseous implants Abutment, Dental, Endosseous implants 21 CFR 872.3630

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

January 30, 2008

Straumann Octa Abutment, K894844 Straumann synOcta Abutment, K994119 Temporary Copings, K894844 ITI Protective Healing Caps, K962023, K051717 RN synOcta® Gold Copings for Bridges, K022859 RN synOcta® Gold Copings for Bars, K894844 RN synOcta® Titanium Copings for Bars, K990342

4. Description of the Device

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K0801239

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5. Intended Use of the Device

Abutments are placed into dental implants to provide support for prosthetic restorations such as crowns, bridges and overdentures, Abutments can be used in single tooth replacements and multiple tooth restorations. The subject abutments are for permanent screw-retained bridges and bar-retained implant-borne dentures. Permanent copings are intended to serve as a base for multi-unit bar or bridge restorations. Temporary Copings are intended to serve as a base for temporary restorations for up to 6 month. Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months.

6. Technological Characteristics

The proposed Bar and Bridge Abutments, Permanent and Temporary Copings and Protective Caps are substantially equivalent to the currently cleared devices. The intended use is identical to the predicate devices. The proposed devices have the same material composition, basic design and fundamental operating principles to the currently cleared devices.

510(k) Submission: RC/NC Bar/Bridge Abutment Line January 30, 2008

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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 2008

Ms. Elaine Alan Regulatory Affairs Specialist Straumann USA 60 Minuteman Road Andover, Massachusetts 01810

Re: K080239 Trade/Device Name: P.004 RC/NC Bar and Bridge Abutment Line P.004 Abutments P.004 Protective Caps P.004 Permanent Bar and Bridge Copings P.004 Temporary Copings Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: April 11, 2008 Received: April 21, 2008

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,

Syrite Y. Michael md.

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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K080239

INDICATIONS FOR USE STATEMENT

Device Name: P.004 Abutments

Indications for Use:

Device Name: P.004 Protective Caps

Indications for Use:

Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months.

Device Name: P.004 Permanent Bar and Bridge Copings

Indications for Use:

Copings are intended to serve as a base for multi-unit bar or bridge restorations.

Device Name: P.004 Temporary Copings Indications for Use:

Temporary Copings are intended to serve as a base for temporary restorations for up to 6 months.

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

Page 1 of 1
510(k) Submission: RC/NC Bar/Bridge Abutment Line
January 30, 2008

510(k) Number:	K080239
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	Straumann US Page 5
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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.)