P.004 Healing Abutments and Closure Screws are intended for use with the Straumann P.004 Bone Level Implant system to protect the inner configuration of the implant. Healing Abutments have a secondary function to maintain, stabilize and form the soft tissue during the healing process.

Device Description

The Straumann 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 device covered in this submission is healing abutments and closure screws. Healing abutments and closure screws are used to protect the inner configuration of the implant and to maintain, stabilize and form the soft tissue. Healing Abutments have a secondary function to maintain, stabilize and form the soft tissue during the healing process

AI/ML Overview

This 510(k) premarket notification (K071585) is for dental healing abutments and closure screws. It does not contain information about a study proving device performance against acceptance criteria in the way a diagnostic AI/ML device submission would. Instead, it demonstrates substantial equivalence to a predicate device, which is the standard regulatory pathway for many medical devices.

Here's an analysis based on the provided document, addressing the requested points:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

This submission does not provide explicit quantitative acceptance criteria or a study demonstrating the device meets them in terms of performance metrics (like sensitivity, specificity, accuracy). Instead, the demonstration of equivalence relies on qualitative comparisons to a predicate device.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Claimed Equivalence)
Intended Use: Identical to predicate device.	P.004 Healing Abutments and Closure Screws: Intended for use with Straumann P.004 Bone Level Implant system to protect inner implant configuration and, for healing abutments, to maintain, stabilize, and form soft tissue during healing process. (Identical to predicate: P.004 RC Healing Abutments, K062129, and P.004 RC Closure Screws, K062129)
Material Composition: Same as predicate device.	NC Healing Abutments and Closure Screws: Same material composition as currently marketed RC Healing Abutments and closure screws.
Basic Design: Same as predicate device.	NC Healing Abutments and Closure Screws: Same basic design as currently marketed RC Healing Abutments and closure screws.
Fundamental Operating Principles: Same as predicate device.	NC Healing Abutments and Closure Screws: Same fundamental operating principles as currently marketed RC Healing Abutments and closure screws.

Study Details (Not Applicable for this Type of Submission):

For this specific device (dental abutments and screws), the regulatory pathway is substantial equivalence, not a performance study as would be expected for a diagnostic or AI/ML device. Therefore, the following points are not directly addressed in the provided document:

Sample size used for the test set and the data provenance: Not applicable. Substantial equivalence is demonstrated through comparative analysis of device characteristics, not a clinical test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a test set is not established in this type of submission.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI/ML diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This device is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this submission is the characteristics and performance of the legally marketed predicate devices.
The sample size for the training set: Not applicable. This device is not an AI/ML model that requires training data.
How the ground truth for the training set was established: Not applicable.

Summary Explanation:

The document, K071585, is a 510(k) summary for Straumann USA's NC Healing Abutments and NC Closure Screws. The core of this submission is to demonstrate substantial equivalence to existing legally marketed predicate devices (P.004 RC Healing Abutments and P.004 RC Closure Screws, K062129).

Instead of presenting results from a performance study against specific acceptance criteria, the manufacturer satisfies regulatory requirements by showing that the new device:

Has the identical intended use as the predicate device.
Shares the same material composition.
Possesses a basic design that is comparable.
Operates on the same fundamental principles.

The FDA's review confirms this substantial equivalence, allowing the device to be marketed without requiring a new, extensive clinical trial as would be necessary for novel devices or those with significantly different characteristics or intended uses. The "study" in this context is the comparative analysis conducted by the manufacturer and reviewed by the FDA to ascertain these equivalences.

Summary

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K071585

Section H 510(k) Summary

JUL 1 1 2007

1. Applicant's Name and Address Straumann USA (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

2. Name of the Device

Trade Name:	NC Healing Abutments, NC Closure Screws
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 Healing Abutments, K062129 P.004 RC Closure Screws, K062129

4. Description of the Device

Healing abutments and closure screws are used to protect the inner configuration of the implant and to maintain, stabilize and form the soft tissue. Healing Abutments have a secondary function to maintain, stabilize and form the soft tissue during the healing process

5. Intended Use of the Device

P.004 Healing Abutments and P.004 Closure Screws are intended for use with the Straumann P.004 Bone Level Implant system to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process.

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K891585

202

6. Basis for Substantial Equivalence

The modified NC Healing Abutments and Closure Screws are substantially equivalent to the currently marketed RC Healing Abutments and closure screws. The intended use is identical to the predicate devices. The proposed abutments and closure screws have the same material composition, 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 Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The bird is black and is positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 1 2007

Ms. Elaine Alan Regulatory Affairs Specialist Straumann USA (on behalf of Institut Straumann AG) 60 Minuteman Road Andover, Massachusetts 01810

Re: K071585

Trade/Device Name: P.004 Healing Abutments and Closure Screws Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 8, 2007 Received: June 11, 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,

Clu

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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K071585

Indications for Use Statement

Device Name: P.004 Healing Abutments and Closure Screws

Indications for Use:

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Kira Hulsey for MSR

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

510(k) Number: K07 |5 85

510(k) Submission: P.004 NC Healing Abutments June 8, 2007 Proprietary and Confidential Straumann US Page 5-43

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.)