PrimaConnex SD Esthetic Contour Zi Abutment is intended for use in conjunction with the PrimaConnex Internal Connection Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations.

Device Description

PrimaConnex SD Esthetic Contour 7: Abutment is intended for use in conjunction with the PrimaConnex Internal Connection Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations.

AI/ML Overview

The provided 510(k) summary for the PrimaConnex® SD Esthetic Contour Zi Abutment (K073032) focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a study with specific acceptance criteria and device performance metrics.

Therefore, the document does not contain information to fill in most of the requested sections regarding acceptance criteria, device performance, study details, sample sizes, expert involvement, or ground truth establishment.

Specifically, there is no mention of a study conducted to prove the device meets any particular acceptance criteria for performance, clinical effectiveness, or standalone algorithm performance. The basis for clearance is substantial equivalence to previously cleared devices.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document does not define specific acceptance criteria or report on device performance metrics through a study. The substantial equivalence argument rests on similar intended use, materials, design, and packaging.

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

Cannot be provided. No test set or study data is described.

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)

Cannot be provided. No test set or related ground truth establishment is described.

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

Cannot be provided. No test set or adjudication process is described.

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

Cannot be provided. This device is a ceramic abutment, not an AI or imaging device. Therefore, an MRMC study is not relevant, and no such study was performed or reported.

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

Cannot be provided. This device is a ceramic abutment, not an algorithm. Therefore, no standalone algorithm performance study was performed or reported.

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

Cannot be provided. No study involving ground truth for performance evaluation is described.

8. The sample size for the training set

Cannot be provided. As there is no AI component, and no performance study mentioned, there is no training set.

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

Cannot be provided. As there is no AI component, and no performance study mentioned, there is no training set or ground truth for it.

Summary of Device Equivalence Argument (from the document):

The submission for the PrimaConnex® SD Esthetic Contour Zi Abutment demonstrates substantial equivalence to predicate devices (PrimaConnex RD and WD Esthetic Contour Zi Abutment (K072572), PrimaConnex Esthetic Contour Abutment (K051614), and PrimaConnex Ceramic Abutment (K062876)) based on the following:

Intended Use: All devices share the same intended use: in conjunction with the PrimaConnex Internal Connection Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations.
Material: The new device and predicates are manufactured from the same material.
Design: The new device incorporates the same design as the predicates.
Packaging: The new device is packaged using the same materials and processes as the predicates.

Therefore, the "proof" that this device meets acceptance criteria is the argument of substantial equivalence to existing legally marketed devices, rather than a de novo performance study against defined acceptance criteria.

Summary

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Special 510(k) ifecore Biomedical, Inc. PrimaConnex® SD Esthetic Contour Zi Abutment KXXXXXX

73032

Section 8: 510(k) Summary (per 21 CFR 807.92)

1. Submitter's Name and Contact Person

Lifecore Biomedical, Inc.	Judith Medlock-Hayes
3515 Lyman Blvd	Regulatory Affairs Specialist
Chaska, MN 55318	Ph: 952-368-6364; Fax: 952-368-4278

2. General Information

Trade Name	PrimaConnex® SD Esthetic Contour ZiAbutment
Common Name	Ceramic Abutment
Classification Name	Endosseous Implant Abutment
Identification of Predicate Devices	PrimaConnex RD and WD EstheticContour Zi Abutment, LifecoreBiomedical (K072572)Esthetic Contour Straight and AngledAbutment for the PrimaConnex InternalConnection Implant System, LifecoreBiomedical (K051614)PrimaConnex Ceramic Abutment,Lifecore Biomedical (K062876)

3. Device Description

4. Intended Use

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Special 510(k) ifecore Biomedical, Inc.

5, Substantial Equivalence Comparison

The summary of how the PrimaConnex® SD Esthetic Contour Zi Abutment is substantially equivalent to the PrimaConnex RD and WD Esthetic Contour Zi Abutment (K072572) is provided below:

Both have the same intended use
Both are manufactured from the same material .
Both incorporate the same design .
Both are packaged using the same materials and processes. .

The summary of how the PrimaConnex® SD Esthetic Contour Zi Abutment is substantially equivalent to the PrimaConnex Esthetic Contour Abutment (K051614) is provided below:

Both have the same intended use
Both incorporate the same design .
Both are packaged using the same materials and processes. .

The summary of how the PrimaConnex® SD Esthetic Contour Zi Abutment is substantially equivalent to the PrimaConnex Ceramic Abutment (K062876) is provided below:

Both have the same intended use
. Both are manufactured from the same material
Both incorporate the same design .
Both are packaged and using the same materials and processes. .

In summary, it is the belief of Lifecore Biomedical, Inc. that the PrimaConnex SD Esthetic Contour Zi Abutment described in this submission is substantially equivalent to the predicate devices.

Confidential

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2007

Ms. Judith Medlock-Hayes Regulatory Affairs Specialist Lifecore Biomedical, Incorporated 3515 Lyman Boulevard Chaska, Minnesota 55318

Re: K073032

Trade/Device Name: PrimaConnex SD Esthetic Contour ZiAbutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 25, 2007 Received: October 29, 2007

Dear Ms. Medlock-Hayes:

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. Clement

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 vours.

Nil R.P. Ogden
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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cial 510(k) core Biomedical, Inc. PrimaConnex® SD Esthetic Contour Zi Abutments

KXXXXXX

tachment B: Indications for Use Statement

0(k) Number (if known):

evice Name: PrimaConnex SD Esthetic Contour Zi Abutment

ndications for Use:

imaConnex SD Esthetic Contour Zi Abutment is intended for use in conjunction with he PrimaConnex Internal Connection Implant System in partially or fully edentulous andibles and maxillae, in support of single or multiple-unit cement retained estorations.

rescription Use X AND/OR Part 21 CFR 801 Subpart D)

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

LEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE F NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russoe

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

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510(k) Number. K673032

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.)