(25 days)
Not Found
No
The document describes dental implants and modifications to their surface. There is no mention of AI or ML technology in the intended use, device description, or the specific sections checked for AI/ML keywords.
Yes
The device is described as an implant intended to support prosthetic devices to restore chewing function in partially edentulous patients, which directly aligns with the definition of a therapeutic device as it is used to treat or manage a physical condition (missing teeth affecting chewing function).
No
The device description indicates that Lifecore's implants are intended for use in supporting single or multiple-unit restorations to restore chewing function. This suggests a therapeutic purpose rather than a diagnostic one.
No
The device description clearly indicates a physical implant (root-form, endosseous implant with a roughened surface) and discusses modifications to its surface. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device implanted into the body (mandibles and maxillae) to support dental prosthetics. This is a surgical/implantable device, not a device used to examine specimens taken from the body.
- Device Description: The description details a "root-form, endosseous implant" with a surface modification. This further confirms it's an implantable device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), providing diagnostic information, or being used in a laboratory setting.
IVD devices are used in vitro (outside the body) to examine specimens and provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) for structural support.
N/A
Intended Use / Indications for Use
Lifecore's implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
Product codes
DZE
Device Description
Lifecore Dental Implants are root-form, endosseous implants with a roughened surface. The modification proposed in this submission will modify the Resorbable Blast Media (RBM) implant surface to add a micro-texture surface morphology to the existing macrotexture. The change to the RBM surface will be incorporated into all Lifecore implant systems that have the RBM surface (Restore, Stage-1, Renova, PrimaSolo and PrimaConnex).
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)
K051614, K050506, K032774, K003226, K002037, K95111, K944068
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Special 510(k) Lifecore Biomedical, Inc. Surface Modification K
Section 8: 510(k) Summary (per 21 CFR 807.92(c))
1. Submitter's Name and Contact Person
OCT 2 3 2007
| Lifecore Biomedical, Inc. | Karen Clement |
|---|---|
| 3515 Lyman Blvd | Regulatory Affairs Manager |
| Chaska, MN 55318 | Ph: 952-368-6294; Fax: 952-368-4278 |
2. General Information
| Trade Name | Restore®, Stage-1®, Renova®, PrimaSolo®, and
PrimaConnex® Dental Implants |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Dental Implant |
| Classification Name | Endosseous Dental Implant |
| Identification of Predicate
Devices | PrimaConnex Internal Connection Implants (K051614)
PrimaSolo One-Piece Implants (K050506)
Renova Internal Hex Implants (K032774)
Stage-1 Single Stage RBM Implant (K003226)
Restore (K002037, K95111, K944068) |
3. Device Description
Lifecore Dental Implants are root-form, endosseous implants with a roughened surface. The modification proposed in this submission will modify the Resorbable Blast Media (RBM) implant surface to add a micro-texture surface morphology to the existing macrotexture. The change to the RBM surface will be incorporated into all Lifecore implant systems that have the RBM surface (Restore, Stage-1, Renova, PrimaSolo and PrimaConnex).
4. Intended Use
Lifecore's implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
1
Special 510(k) Lifecore Biomedical, Inc. Surface Modification K 072768 2012
5. Substantial Equivalence Comparison
A summary of how the subject devices are substantially equivalent to the predicate devices is provided below:
- All have the same intended use. .
- All incorporate the same biocompatible materials, .
- All incorporate the identical design, .
- . All have the same shelf life, and
- All are packaged and sterilized using the same materials and processes. .
In summary, it is the belief of Lifecore Biomedical, Inc. that the subject implants described in this submission are 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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 3 2007
Ms. Karen Clement Regulatory Affairs Manager Lifecore Biomedical, Incorporated 3515 Lyman Boulevard Chaska, Minnesota 55318
Re: K072768
Trade/Device Name: Restore®, Stage-1®, Renova®, PrimaSolo® and PrimaConnex® Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: September 27, 2007 Received: September 28, 2007
Dear Ms. Clement:
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 yours,
Neil R.P. Ogden
Chin Lin, Ph.D., FAC
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
The PrimaSolo One-Piece (3.0mm) Implant is a threaded one-piece implant with an integrated abutment designed for single-stage surgical procedure and is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. Mandible central and lateral incisors must be splinted if using two or more 3.0mm implants adjacent to one another.
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 2 of 2
10% /
Suser Romer
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K672768