(83 days)
No
The device description focuses on the material and physical design of ceramic copings, with no mention of software, algorithms, or any AI/ML related terms.
No
The device is a core structure for prosthetic restorations, which replaces a missing body part rather than treating a disease or condition.
No
The device is described as a core structure for a prosthetic restoration, specifically ceramic copings, not for identifying a disease or condition.
No
The device description clearly states the device is a physical ceramic coping manufactured from Yttria-Stabilized Tetragonal Zirconia (Y-TZP).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the PrimaConnex Ceramic Copings are for use as a core structure for prosthetic restorations in the mouth (mandibles and maxillae). This is a direct medical device used within the body.
- Device Description: The description details a physical component made of ceramic material designed to be cemented onto an abutment in the mouth.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples for diagnostic purposes. This device is a dental prosthetic component used inside the body.
N/A
Intended Use / Indications for Use
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.
Product codes
ELL
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibles and maxillae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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™ Ceramic
Coping |
|-------------------------------------|---------------------------------------------------------------------|
| Common Name | Ceramic coping |
| Classification Name | Porcelain tooth |
| Identification of Predicate Devices | • Procera® Copings and Pontic (Nobel
Biocare USA Inc.) (K032562) |
3. 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).
1
4. Intended Use
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.
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.
3
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
4
Indications for Use
510(k) Number (if known):
PrimaConnex™ Ceramic Copings Device Name:
Indications for Use:
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.
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