(21 days)
Not Found
No
The summary describes a dental abutment, a passive mechanical component, and contains no mention of AI, ML, image processing, or performance studies typically associated with AI/ML devices.
No.
The device is an abutment for dental implants, used to support restorations, not to treat or prevent a disease or condition directly.
No
The device is described as an abutment intended for use with an implant system to support dental restorations, not to diagnose a condition.
No
The device description clearly states it is an "Abutment," which is a physical component used in dental implants, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for supporting dental restorations in the mouth (mandibles and maxillae). This is a direct clinical application within the body.
- Device Description: The description reiterates the use in conjunction with a dental implant system for supporting restorations.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health status. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
This device is a dental abutment, which is a component used in dental implant systems to connect the implant to the prosthetic restoration (like a crown or bridge). This is a medical device used in vivo (within the body), not in vitro (outside the body).
N/A
Intended Use / Indications for Use
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.
Product codes
NHA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or fully edentulous 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)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 Zi
Abutment |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Ceramic Abutment |
| Classification Name | Endosseous Implant Abutment |
| Identification of Predicate Devices | PrimaConnex RD and WD Esthetic
Contour Zi Abutment, Lifecore
Biomedical (K072572)
Esthetic Contour Straight and Angled
Abutment for the PrimaConnex Internal
Connection Implant System, Lifecore
Biomedical (K051614)
PrimaConnex Ceramic Abutment,
Lifecore Biomedical (K062876) |
3. 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.
4. Intended Use
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.
1
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
2
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.
3
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
4
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
Page 1 of 1
510(k) Number. K673032
Confidential