PrimaConnex Ceramic Copings are intended for use as a core structure for a prosthetic restoration in partially or fully edentulous mandibles and maxillae, in the construction of single-unit cement retained restorations.

The copings are designed to fit Lifecore's PrimaConnex Quick-Abutment.

Device Description

Lifecore Biomedical PrimaConnex Ceramic Copings are pre-manufactured for use as a core structure in the construction of single-unit cement retained restorations. The Ceramic Copings will be offered in three sizes; Small Diameter (SD), Regular Diameter (RD), and Wide Diameter (WD) to fit with the corresponding PrimaConnex Quick-Abutments, previously cleared under K051614. The Ceramic Coping contains an internal flat for anti-rotation and is cemented onto the Quick-Abutment after completion of the prosthetic restoration.

The Ceramic Copings are manufactured from Yttria-Stabilized Tetragonal Zirconia (Y-TZP) in conformance with ISO Standard 13356, Implants for Surgery – Ceramic Abutments Based on Yttria-Stabilized Tetragonal Zirconia (Y-TZP).

AI/ML Overview

The provided text is a 510(k) summary for a dental device, the Lifecore PrimaConnex™ Ceramic Coping. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical study data with specific acceptance criteria, statistical analyses, or detailed performance metrics typically found in clinical trial reports for diagnostic or AI-driven devices.

Therefore, many of the requested elements (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, ground truth details, effect sizes) are not applicable or not present in this document.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

Since this is a submission for a device component (ceramic coping for dental restorations) and the 510(k) process focuses on substantial equivalence, there are no explicit "acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, or reader agreement) in this document. Instead, the "acceptance criteria" can be inferred as demonstration of substantial equivalence to existing, legally marketed predicate devices, primarily based on material conformity and intended use.

The device performance is described in terms of its characteristics and conformity to standards, rather than clinical efficacy data.

Acceptance Criteria (Inferred from 510(k) process)	Reported Device Performance
Material Conformity: Device material meets relevant ISO standards.	Manufactured from Yttria-Stabilized Tetragonal Zirconia (Y-TZP) in conformance with ISO Standard 13356.
Intended Use Equivalence: Device intended use is comparable to predicate.	Intended for use as a core structure for a prosthetic restoration in partially or fully edentulous mandibles and maxillae, in the construction of single-unit cement retained restorations. This is stated to be similar to predicate devices.
Design Equivalence: Device design is comparable to predicate for its stated purpose.	Incorporates equivalent coping designs to predicate devices. Offered in three sizes (SD, RD, WD) to fit corresponding PrimaConnex Quick-Abutments. Contains an internal flat for anti-rotation.
Safety and Effectiveness: No new questions of safety or effectiveness raised compared to predicates.	"When compared with the predicate devices, no new questions of safety or effectiveness have been raised for the PrimaConnex Ceramic Copings."

Study Information

Sample size used for the test set and the data provenance:
- Not applicable/Not provided. This is a material and design equivalence submission, not a study evaluating performance on a patient test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided.
Adjudication method for the test set:
- Not applicable/Not provided.
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 is not an AI-driven device or a diagnostic device subject to MRMC studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" equivalent for this type of submission is the established safety and effectiveness of the predicate devices and the conformity of the new device's material and design to relevant standards which ensures performance comparable to the predicates without raising new safety/effectiveness concerns.
The sample size for the training set:
- Not applicable/Not provided.
How the ground truth for the training set was established:
- Not applicable/Not provided.

Summary

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K060530

Y 22 2006

510(K) SUMMARY AND CERTIFICATION [As required by 21 CFR 807.92(c)]

1. Submitter's Name and Contact Person

Lifecore Biomedical, Inc.	Rachel Kennedy
3515 Lyman Blvd	Regulatory Affairs Manager
Chaska, MN 55318	Ph: 952-368-6294; Fax: 952-368-4278

2. General Information

Trade Name	Lifecore PrimaConnex™ CeramicCoping
Common Name	Ceramic coping
Classification Name	Porcelain tooth
Identification of Predicate Devices	• Procera® Copings and Pontic (NobelBiocare USA Inc.) (K032562)

3. Device Description

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4. Intended Use

5. Substantial Equivalence Comparison

The PrimaConnex Ceramic Copings are substantially equivalent to the predicate devices. All copings are intended for use as a core structure for a prosthetic restoration. The subject and predicate devices are intended for single use only. The Lifecore PrimaConnex Ceramic Copings are similar in fundamental scientific technology to the predicate devices in that they incorporate equivalent coping designs, materials, and intended use. When compared with the predicate devices, no new questions of safety or effectiveness have been raised for the PrimaConnex Ceramic Copings.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures. The symbol is composed of three curved lines that converge at the bottom, creating a sense of unity and support.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 22 2006

Ms. Rachel Kennedy Regulatory Affairs Manager Lifecore Biomedical, Incorporated 3515 Lyman Boulevard Chaska, Minnesota 55318

Re: K060530

Trade/Device Name: PrimaConnex™ Ceramic Copings Regulation Number: 21 CFR 872.3920 Regulation Name: Porcelain Tooth Regulatory Class: II Product Code: ELL Dated: February 27, 2006 Received: February 28, 2006

Dear Ms. Kennedy:

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. Kennedy

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. Michael Oms

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

510(k) Number (if known):

PrimaConnex™ Ceramic Copings Device Name:

Indications for Use:

The copings are designed to fit Lifecore's PrimaConnex Quick-Abutment.

Prescription Use X AND/OR (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Susan Runner

(") a Ji Anesthestology, General Hospital, on Control, Dental Devices

060530

Regulation Number and Section

§ 872.3920 Porcelain tooth.

(a)
Identification. A porcelain tooth is a prefabricated device made of porcelain powder for clinical use (§ 872.6660) intended for use in construction of fixed or removable prostheses, such as crowns and partial dentures.(b)
Classification. Class II.