(79 days)
Not Found
No
The summary describes a dental implant system and associated tools, with no mention of AI or ML capabilities.
No.
The device is a dental implant system used for supporting single or multiple-unit restorations in partially or fully edentulous mandibles and maxillae, which is a restorative rather than therapeutic function.
No
The device is described as an implant system for dental restorations, focusing on structural support and surgical instrumentation, not on diagnosing medical conditions.
No
The device description clearly outlines physical components like implants, abutments, and surgical/restorative instrumentation, indicating it is a hardware-based medical 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 surgical and restorative procedure performed directly on a patient.
- Device Description: The description details dental implants, abutments, and surgical/restorative instruments. These are all physical devices used in a surgical setting.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a medical device used for surgical implantation and dental restoration.
N/A
Intended Use / Indications for Use
The Lifecore Biomedical RENOVA™ Internal Hex Implant System is 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
The Lifecore Biomedical RENOVA Internal Hex Implant System consists of two-stage, rootform tapered and straight walled threaded dental implants and associated abutment systems, which provide the clinician with Screw-Retained (UCLA or Universal, Cement-on-Crown (COC), and Overdenture Snap Abutments. The system also includes surgical and restorative instrumentation: twist drills, surgical taps, surgical depth probe, depth gauges, abutment drivers, latch-type drivers, open end wrench, and hand-piece adapters. Lifecore RENOVA implants are available with a Resorbable Blast Media (RBM) roughened surface. All implants have an internal hexagon as a connection and as an anti-rotational feature for the prosthetics.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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.)
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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.
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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).
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§ 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
510(K) SUMMARY AND CERTIFICATION
KO 32774
NOV 2 6 2003 [As required by 21 CFR 807.92(c)]
1. Submitter's Name / Contact Person
| Lifecore Biomedical, Inc. | Diane Brinza |
|---|---|
| 3515 Lyman Blvd | Regulatory Affairs Supervisor |
| Chaska, MN 55318 | Ph: 952-368-6394; Fax: 952-368-4278 |
2. General Information
| Trade Name | RENOVA™ Internal Hex Implant System |
|---|---|
| Common Name | Endosseous dental implant system |
| Classification Name | Endosseous implant |
| Identification of | |
| Predicate Devices | Sulzer Dental, Inc.; Screw-Vent and Tapered Screw-Vent |
| Implants; (K013227) | |
| Lifecore Biomedical, Inc.; Restore Self-Tapping | |
| Implant;(K924589) |
3. Device Description
The Lifecore Biomedical RENOVA Internal Hex Implant System consists of two-stage, rootform tapered and straight walled threaded dental implants and associated abutment systems, which provide the clinician with Screw-Retained (UCLA or Universal, Cement-on-Crown (COC), and Overdenture Snap Abutments. The system also includes surgical and restorative instrumentation: twist drills, surgical taps, surgical depth probe, depth gauges, abutment drivers, latch-type drivers, open end wrench, and hand-piece adapters. Lifecore RENOVA implants are available with a Resorbable Blast Media (RBM) roughened surface. All implants have an internal hexagon as a connection and as an anti-rotational feature for the prosthetics.
4. Intended Use
The Lifecore Biomedical RENOVA Internal Hex Implant System is 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.
5. Substantial Equivalence Comparison
The RENOVA Internal Hex Implant System and the predicate Sulzer Dental Screw-Vent implants share a substantially equivalent intended use. The RENOVA, Screw-Vent and Lifecore Biomedical Restore Self-Tapping implants are similar in fundamental scientific technology in that they are all threaded, root form implants constructed of titanium with
1
roughened surfaces. The subject and predicate devices are similar in size and materials. All three systems offer abutment systems for cement-retained, screw-retained and overdenture restorations as well as associated accessories and instruments. When compared with the predicate devices, no new questions of safety or effectiveness have been raised for the RENOVA system.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 6 2003
Ms. Diane Brinza Regulatory Affairs Supervisor Lifecore Biomedical, Incorporated 3515 Lyman Boulevard Chaska, Minnesota 55318-3051
Re: K032774
Trade/Device Name: RENOVA™ Internal Hex Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: September 5, 2003 Received: September 8, 2003
Dear Ms. Brinza:
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.
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Page 2 - Ms. Brinza
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 (301) 594-4613. 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/dsma/dsmamain.html
Sincerely yours.
Robert Betz DDS for Dr Chiu Lin
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
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INDICATIONS FOR USE STATEMENT
Page 1 of 1
510(k) Number (if known):
Device Name: RENOVA™ Internal Hex Implant System
510(k) Number:
Intended Use / Indications for Use:
The Lifecore Biomedical RENOVA™ Internal Hex Implant System is 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.
Robert B. Betz DDS for Dr. Susan Renner
thesiology. General Hospital, n Control, Dental Devices
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)