The RC Temporary Abutment is intended for use with the P.004 dental implant for temporary restoration of single crowns and bridges in the anterior and posterior region for use up to six months.

Healing abutments, often referred to as healing caps, are intended to be used with the P.004 dental implant to protect the inner configuration of the implant during the healing process and maintain, stabilize and form the soft tissue during this phase.

P.004 RC Temporary Abutment is indicated for use in Straumann P.004 RC Bone Level implants for temporary restorations of single crowns and bridges for up to six months.

P.004 Healing Abutment, customizable (cap) is indicated for use in Straumann P.004 RC Bone Level implants to protect the inner configuration of the implant during the healing process. Maintains, stabilizes and forms the soft tissue and should be placed out of occlusion for up to six months.

Device Description

The Straumann P.004 Dental Implant System is an integrated system of endosseous bone level 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 temporary abutments.

The basal portion of the abutments has 4 protrusions diametrically opposed that engage in the 4 grooves of the P.004 implant. The abutments are 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. Healing abutments protect the inner configuration of the abutment and contours the soft tissue during the healing phase.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the device, organized as requested:

Device: Straumann P.004 RC Temporary Abutments and P.004 Healing Abutments

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or reported device performance metrics in a study context. Instead, the submission focuses on establishing substantial equivalence to predicate devices based on intended use, materials, basic design, and fundamental operating principles.

Based on the available information, the implicit "acceptance criteria" revolve around demonstrating substantial equivalence to the predicate devices and fulfilling the stated intended use without adverse events or deviations from established performance.

Therefore, a table would look like this, with the understanding that "reported performance" here refers to the rationale for substantial equivalence rather than explicit quantitative study results against pre-defined thresholds:

Acceptance Criteria (Inferred from 510(k) submission)	Reported Device Performance (Rationale from submission)
Intended Use: For temporary restoration of single crowns and bridges (Temporary Abutment) and protecting inner implant configuration, maintaining, stabilizing, and forming soft tissue (Healing Abutment) with P.004 dental implants for up to six months.	The RC Temporary Abutment is "intended for use with the P.004 dental implant for temporary restoration of single crowns and bridges in the anterior and posterior region for use up to six months." Healing Abutments "are intended to be used with the P.004 dental implant to protect the inner configuration of the implant during the healing process and maintain, stabilize and form the soft tissue during this phase." The intended use is "identical to the predicate devices."
Materials: Material composition is safe and effective for temporary use.	The materials "are identical to the predicate devices."
Design and Function: Basic design and operating principles are consistent and safe.	The proposed abutments "have the same basic design and fundamental operating principles to the currently marketed devices." The basal portion has 4 protrusions engaging 4 grooves of the P.004 implant, seated with a screw. Used for cemented and screw-retained restorations.
Substantial Equivalence: Demonstrate equivalence to predicate devices.	"The proposed abutments are substantially equivalent to the currently marketed devices." This is the core finding of the 510(k) process by the FDA.

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

The provided text does not describe a "test set" in the context of a clinical performance study with human subjects or a statistical evaluation of device performance data. The submission is a 510(k) premarket notification for substantial equivalence, which primarily relies on comparing the new device to existing, legally marketed predicate devices.

There is no mention of a traditional "sample size" for a test set, nor any specific data provenance (e.g., country of origin, retrospective/prospective) for a clinical performance evaluation. The "data" presented is largely a comparison of specifications and intended use against predicate devices.

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

This information is not applicable to this 510(k) submission as it focuses on demonstrating substantial equivalence rather than presenting clinical study data with ground truth established by experts. The "expertise" involved would be that of the manufacturer's engineers and regulatory affairs personnel in preparing the submission, and the FDA reviewers in evaluating it against regulatory requirements and established predicate devices.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons stated above. There is no described "test set" and thus no need for an adjudication method.

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

This information is not applicable. The device described (dental abutments) is a physical medical device, not an AI software intended to assist human readers (e.g., in medical imaging interpretation). Therefore, an MRMC study related to AI assistance would not be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. As mentioned, the device is a physical dental abutment, not an algorithm or AI system.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For this 510(k) submission, the "ground truth" is established through regulatory precedent and technical specifications.

Regulatory Precedent: The existence of already "legally marketed predicate devices" (Straumann P.004 Dental Implants, synOcta® Temporary Meso Abutment, P.004 RC Meso Abutment) serves as the primary ground truth. The new device is compared against these predicates to demonstrate it is "substantially equivalent" in terms of safety and effectiveness.
Technical Specifications: The design, materials, and intended use of the new abutments are compared directly to those of the predicate devices. This involves engineering specifications and material data, validated against known safe and effective performance of the predicate.

There is no mention of clinical outcomes data, expert consensus on specific cases, or pathology reports used to establish ground truth for this particular submission.

8. The Sample Size for the Training Set

This information is not applicable. This submission describes a physical medical device, not a machine learning model, so there is no "training set" in the computational sense.

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

This information is not applicable for the same reasons as above.

Summary

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SEP 2 0 2007

Section K 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 Fax Number: 978-747-0023 Contact Person: Elaine Alan Regulatory Affairs Specialist Date of Submission: February 9, 2007

2. Name of the Devices

Trade Name:	RC Temporary Abutments
Common Name:	Abutment, Dental, Endosseous implants
Classification Name:	Abutment, Dental, Endosseous implants
	21 CFR 872.3640

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

Straumann P.004 Dental Implants, K062129 synOcta® Temporary Meso Abutment, K051717 P.004 RC Meso Abutment, K062129

4. Description of the Device

5. Intended Use of the Device

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The RC Temporary Abutment is intended for use with the P.004 dental implant for temporary restoration of single crowns and bridges in the anterior and posterior region for use up to six months.

6. Technological Characteristics

The proposed abutments are substantially equivalent to the currently marketed devices. The intended use and materials are identical to the predicate devices. The proposed abutments have the same basic design and fundamental operating principles to the currently marketed devices.

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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 eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

SEP 2 0 2007

Re: K070478 Trade/Device Name: P.004 RC Temporary Abutment, P.004 Healing Abutment, customizable (cap) Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 21, 2007 Received: August 22, 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 (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.

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.

Sougie J.M. Michaux Davis

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

Indications for Use: 1070478

Device Name

P.004 RC Temporary Abutment is indicated for use in Straumann P.004 RC Bone Level implants for temporary restorations of single crowns and bridges for up to six months.

Device Name

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)

Page 1 of 1

Susan Russer

ision Sign-Off) vision of Anesthesiology, General Hospital, Infection Control, Dental Devices

Number: K670478

510(k) Submission: P.004 Temporary Abutments February 16, 2007

Straumann US Page 11 of 36

Proprietary and Confidential

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.)