(36 days)
Not Found
No
The summary describes a ceramic abutment for dental implants, a purely mechanical device, and contains no mention of software, algorithms, or AI/ML terms.
No
The device is an abutment for dental implants, used to support restorations, which is a structural component rather than a device for treating or curing a medical condition.
No
The device, PrimaConnex Ceramic Abutments, is described as being used in conjunction with an implant system to support dental restorations. Its function is to provide structural support for crowns, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a "Ceramic Abutment," which is a physical component used in dental implants, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the PrimaConnex Ceramic Abutments are intended for use in conjunction with an implant system to support dental restorations in the mouth (mandibles and maxillae). This is a device used within the body for structural support, not for testing samples outside the body.
The information provided describes a dental implant component, which is a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
PrimaConnex Ceramic Abutments are 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.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
PrimaConnex Ceramic Abutments are 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.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.)
0
K062876
Lifecore Biomedical, Inc. Special 510(k) Premarket Notification PrimaConnex® Ceramic Abutments
NOV - 1 2006
510(K) SUMMARY [As required by 21 CFR 807.92(c)]
1. Submitter's Name and Contact Person
| Lifecore Biomedical, Inc. | Brian Smekal |
|---|---|
| 3515 Lyman Blvd | Regulatory Affairs Specialist |
| Chaska, MN 55318 | Ph: 952-368-6306; Fax: 952-368-4278 |
2. General Information
| Trade Name | PrimaConnex® Ceramic Abutments |
|---|---|
| Common Name | Ceramic Abutments |
| Classification Name | Endosseous Implant Abutment |
| Identification of Predicate Devices | Esthetic Contour Straight Abutments for |
| the PrimaConnex Internal Connection | |
| Implant System, Lifecore Biomedical | |
| (K051614) |
PrimaConnex Ceramic Copings, Lifecore
Biomedical (K060530)
Astra Tech Implants - Dental System
Ceramic Abutment, Astra Tech, Inc.
(K023631) |
3. Device Description
PrimaConnex Ceramic Abutments are 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.
4. Intended Use
PrimaConnex Ceramic Abutments are intended for use in conjunction with the PrimaConnex Internal Connection Implant System in partially or fully edentulous
1
Lifecore Biomedical, Inc. Special 510(k) Premarket Notification PrimaConnex® Ceramic Abutments
mandibles and maxillae, in support of single or multiple-unit cement retained restorations.
5. Substantial Equivalence Comparison
Summary of how the PrimaConnex Ceramic Abutment is substantially equivalent to the PrimaConnex Esthetic Contour Abutment (K051614):
- . Have the same intended use,
- Incorporate the identical design, .
- . Have the same shelf life, and
- Are packaged and sterilized using the same materials and processes. .
Summary of how the PrimaConnex Ceramic Abutment is substantially equivalent to the PrimaConnex Ceramic Copings (K060530):
- Incorporate the identical biocompatible material, .
- Are packaged using the same materials and processes. .
Summary of how the PrimaConnex Ceramic Abutment is substantially equivalent to the Astra Tech Implants - Dental System Ceramic Abutment (K023631):
- Have the same intended use, .
- Incorporate the identical biocompatible material, .
- Incorporate the same fundamental scientific technology. .
In summary, the PrimaConnex Ceramic Abutment described in this submission is, in our opinion, substantially equivalent to the predicate devices.
2
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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Brain Smekal Regulatory Affairs Specialist Lifecore Biomedical, Incorporated 3515 Lyman Boulevard Chaska, Minnesota 55318
NOV - 1 2006
Re: K062876
Trade/Device Name: PrimaConnex® Ceramic Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 20, 2006 Received: October 24, 2006
Dear Mr. Smekal:
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 - Mr. Smekal
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Liu, Ph.D.
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 Statement
510(k) Number: K062876
Device Name: PrimaConnex® Ceramic Abutments
Indications for Use:
PrimaConnex Ceramic Abutments are 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.
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)
Suser Punes
READON, Gener John, Donner De
Page 1 of 1