(88 days)
Not Found
No
The description mentions "computer-assisted technology" for milling, which is CAD/CAM, but there is no mention of AI or ML for decision-making, image analysis, or other functions.
No.
The device is described as an accessory to an endosseous implant to support a prosthetic device and is used for constructing single-unit cement-retained restorations. It does not treat or cure a disease or condition.
No
The device is an abutment system used to support prosthetic devices on dental implants, not to diagnose medical conditions.
No
The device description explicitly states that the abutments and copings are "milled using computer-assisted technology" and are physical components placed onto a dental implant. This indicates a hardware device, not software only.
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 device is an accessory to a dental implant to support a prosthetic device in a patient. This is a direct interaction with the patient's body for structural support, not for examining specimens derived from the human body.
- Device Description: The description details a physical device (abutments and copings) that are placed onto a dental implant to support a restoration. This is a mechanical function within the patient's mouth.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis, monitoring, or treatment decisions based on in vitro analysis.
IVD devices are used to examine specimens from the human body to provide information for diagnostic purposes. This device is a medical device used for structural support within the body.
N/A
Intended Use / Indications for Use
The Lifecore PrimaConnex CAD/CAM Abutment System is intended for use as an accessory to a Lifecore PrimaConnex endosseous implant to support a prosthetic device in a partially or completely edentulous patient. They are intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The 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 on Lifecore PrimaConnex CAD/CAM Abutments.
Product codes (comma separated list FDA assigned to the subject device)
NHA, ELL
Device Description
The PrimaConnex CAD/CAM Abutments and abutment-specific ceramic copings are placed onto the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations.
The abutments and copings are milled using computer-assisted technology that enables the creation of final abutments that are manufactured with specific geometry to meet individual anatomic variations in patient tooth and jaw structure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mandible or maxilla
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)
Static and Dynamic Fatigue Testing of Endosseous Dental Implant Systems – PrimaConnex CAD/CAM Abutment System
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.
K041645, K051614, K053373, K060530, K070833
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
510(k) SUMMARY AND CERTIFICATION [As required by 21 CFR 807.92(c)]
| 1. Submitter's Name and Contact Person | NOV 9 2007 | |
|---|---|---|
| Lifecore Biomedical, Inc. | ||
| 3515 Lyman Blvd | ||
| Chaska, MN 55318 | Judith Medlock-Hayes | |
| Regulatory Affairs Specialist | ||
| Ph: 952.368.6364; Fax: 952.368.4278 |
2. General Information
| Trade Name | Lifecore PrimaConnex® CAD/CAM
Abutment System |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Endosseous dental implant abutment
Ceramic Coping |
| Classification Name | Abutment: Endosseous dental implant
abutment
21 CFR §872.3630,
Coping: Porcelain Tooth
21 CFR §872.3290 |
| Product Code | NHA, ELL |
| Identification of Predicate Devices | DDS-ZR Zirconia (DDS Services) (K041645) PrimaConnex Implant System
(Lifecore Biomedical, Inc.) (K051614) Atlantis Components' Abutment for
Zimmer Internal Connection (Atlantis
Components, Inc.) (K053373) PrimaConnex Ceramic Copings
(Lifecore Biomedical, Inc.) (K060530) Atlantis Components' Abutment for
Astra Implant (Atlantis Components,
Inc.) (K070833) |
1
3. Device Description
The PrimaConnex CAD/CAM Abutments and abutment-specific ceramic copings are placed onto the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations.
The abutments and copings are milled using computer-assisted technology that enables the creation of final abutments that are manufactured with specific geometry to meet individual anatomic variations in patient tooth and jaw structure.
4. Intended Use
The Lifecore PrimaConnex CAD/CAM Abutment System is intended for use as an accessory to a Lifecore PrimaConnex endosseous implant to support a prosthetic device in a partially or completely edentulous patient. They are intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The 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 on Lifecore PrimaConnex CAD/CAM Abutments.
5. Substantial Equivalence Comparison
The PrimaConnex CAD/CAM Abutment System and predicate devices are substantially equivalent in intended use, material composition, fundamental scientific technology, principles of operation, and basic design. When compared with the predicate devices, no new questions of safety or effectiveness have been raised for the PrimaConnex CAD/CAM Abutment System.
2
Summary of Attachments
| Attachment A: | Device and Accessory Drawings |
|---|---|
| Attachment B: | Static and Dynamic Fatigue Testing of Endosseous Dental |
| Implant Systems – PrimaConnex® CAD/CAM Abutment | |
| System | |
| Attachment C: | Predicate Device Information |
| Attachment D: | Declaration of Conformity |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of a human figure with three arms or lines extending from the head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 9 2007
Ms. Judith Medlock-Hayes Regulatory Affairs Specialist Lifecore Biomedical, Incorporated 3515 Lyman Boulevard Chaska, Minnesota 55318
Rc: K072241
Trade/Device Name: PrimaConnex® CAD/CAM Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA, ELL Dated: August 10, 2007 Received: August 13, 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.
4
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 vour 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.
Nail R. Qghn
Chiu Lin, Ph.D.,
hiu 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
5
Indications for Use
510(k) Number (if known):
Device Name: PrimaConnex® CAD/CAM Abutment System
Indications for Use:
The Lifecore PrimaConnex® CAD/CAM Abutment System is intended for use as an accessory to a Lifecore PrimaConnex endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The 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 on Lifecore PrimaConnex CAD/CAM Abutments.
Prescription Use X_________ AND/OR
Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runns
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K072241