(319 days)
No
The summary describes a physical dental implant system and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to reconstruct chewing function and support prosthetic devices, which are therapeutic interventions addressing a medical condition (edentulism or partial edentulism).
No
The SATURN Dental Implant System is stated to be intended for surgical placement to support crowns, bridges, or overdentures, and to provide support for prosthetic devices and restore chewing function. It is a therapy device, not a diagnostic one.
No
The device description clearly outlines physical components made of titanium alloy (implants, abutments, screws) and describes their mechanical function and material composition. There is no mention of software as a component of the device itself.
Based on the provided information, the SATURN Dental Implant System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for surgical placement in the body to support prosthetic devices and restore chewing function. This is a therapeutic and structural function within the body.
- Device Description: The description details a physical implant made of titanium alloy designed to be surgically inserted into bone.
- Function: The described function is mechanical support and restoration of chewing function, not the examination of specimens derived from the human body.
IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The SATURN Dental Implant System does not perform any such function.
N/A
Intended Use / Indications for Use
The SATURN Dental Implant System is intended for surgical placement in the maxillary or the mandibular arch, to support crowns, bridges, or over dentures, in edentulous or partially edentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth restoration for immediate loading after extraction when good primary stability is achieved and with appropriate occlusal loading. The procedure can be accomplished in a one-stage or two-stage surgical operation.
Product codes
DZE, NHA
Device Description
The SATURN Dental Implant employs a new strategy that of extended sub-crestal threads, expanded out in a wing-like effect to engage socket walls mid-crestally. The implants material composition is: TI 6AL 4V - ELI. The system consists of a variety of bone screw implants in three diameters ø 3.8, 4.2, 5.0 mm diameter. Each respective diameter is available in various lengths from 8 mm to 16mm. The bone screw (implant) is connected to the abutment via an internal connecting screw while the alignment of the abutment is determined. SATURN Dental Implants are tapered internal hex implants, designed to enable easy insertion, while supporting initial stability. The variable thread (coil) design enables self-tapping, thus providing solution for a variety of bone conditions.The internal hexagon helps to minimize rotation. SATURN Dental Implant System offers a solution for immediate placement and immediate loading.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary or the mandibular arch
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)
NON-CLINICAL TEST: Static and dynamic compression performance test was conducted per ISO 14801:2007- Dentistry-Implants- Dynamic fatigue test for Endosseous Dental implants. The worst case scenario was chosen based on the FDA guideline "Class 11 Special Controls Guidance Document: Root- form for Endosseous dental implants and Endosseous dental Implant Abutments". Fatique test of the longest implant(16mm) in combination with the highest angled abutment(30°) was conducted. The results of this testing indicate that the SATURN Dental Implant System is equivalent to the predicate devices cited in this submission.
CLINICAL TEST: Clinical Evaluation of SATURN Dental Implant System Case Reports: Long-term results of several patients implanted with the SATURN Dental Implant System were presented and support the biomechanical theory concerning the loading on the implant. The implant wing reduces the pressure on the implant neck resulting in less absorption in the neck. The cases presented in this report show no bone loss in the neck of the implanted SATURN.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Nobel Active - K071370, Straumann Bone Level Implant - K121131
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.
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Cortex Dental Implants Industries Ltd
510k Premarket Notification- SATURN Dental Implant System
510(k) Summary
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Cortex SATURN Dental Implant System
1. GENERAL INFORMATION
| Date Prepared: | March 17th, 2014 |
|---|---|
| Sponsor: | Cortex Dental Implants Industries Ltd. |
| P.O. Box 125, Industrial Zone | |
| Shlomi, 22832 Israel | |
| Contact: | Mrs. Simha Sibony, |
| Qualitech | |
| P.O.Box 12082 | |
| Nahariya 2201202 ISRAEL | |
| Cell: +972-52-654-6625 | |
| Fax: +972-4-9000389 | |
| Simha.QualiTech@gmail.com | |
| Trade Name: | SATURN Dental Implant System |
| Common Name: | Endosseous Dental Implant |
| Classification | |
| Name: | Implant, Endosseous, Root-Form |
| Class: | II |
| Product Code: | DZE/NHA |
| CFR section: | 21 CFR section 872.3640/872.3630 |
| Device Panel: | Dental |
| Legally | |
| marketed | |
| predicate | |
| devices: | Nobel Active - K071370 |
| Straumann Bone Level Implant - K121131 | |
| Intended Use: | The SATURN Dental Implant System is intended for surgical |
| placement in the maxillary or the mandibular arch, to support crowns, | |
| bridges, or over dentures, in edentulous or partially edentulous | |
| patients. It is intended to provide support for prosthetic devices, such | |
| as artificial teeth, and to restore the patient's chewing function. | |
| The System is intended to be used in either single tooth or multiple | |
| teeth restoration for immediate loading after extraction when good | |
| primary stability is achieved and with appropriate occlusal loading. | |
| The procedure can be accomplished in a one-stage or two-stage | |
| surgical operation. |
1
510k Premarket Notification- SATURN Dental Implant System
DEVICE DESCRIPTION 2.
The SATURN Dental Implant employs a new strategy that of extended sub-crestal threads, expanded out in a wing-like effect to engage socket walls mid-crestally. The implants material composition is: TI 6AL 4V - ELI
The system consists of a variety of bone screw implants in three diameters ø 3.8, 4.2, 5.0 mm diameter. Each respective diameter is available in various lengths from 8 mm to 16mm. The bone screw (implant) is connected to the abutment via an internal connecting screw while the alignment of the abutment is determined.
SATURN Dental Implants are tapered internal hex implants, designed to enable easy insertion, while supporting initial stability. The variable thread (coil) design enables self-tapping, thus providing solution for a variety of bone conditions.The internal hexagon helps to minimize rotation. SATURN Dental Implant System offers a solution for immediate placement and immediate loading.
The SATURN Dental Implant System is cleared for marketing in Europe. The device was implanted in thousands of patients in Israel and Europe.
Materials:
The components are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136.
Function:
The SATURN Dental Implant System is intended for surgical placement in the maxillary and/or the mandibular arch, to support crowns, bridges, or over dentures, in edentulous or partially edentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.
The System is intended to be used in either single tooth or multiple teeth restoration for immediate loading after extraction when good primary stability is achieved and with appropriate occlusal loading.
The procedure can be accomplished in a one-stage or two-stage surgical operation.
INTENDED USE 3.
The SATURN Dental Implant System is intended for surgical placement in the maxillary and/or the mandibular arch, to support crowns, bridges, or over dentures, in edentulous or partially edentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.
The System is intended to be used in either single tooth or multiple teeth restoration for immediate loading after extraction when good primary stability is achieved and with appropriate occlusal loading. The procedure can be accomplished in a one-stage or two-stage surgical operation.
2
510k Premarket Notification- SATURN Dental Implant System
SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES 4.
The Saturn Dental Implant System is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances. Specifically the intended us of all three systems is to restore chewing function by insertion of the implant into the maxilla or mandible to support single crowns or multi-unit restorations.
| Saturn | Nobel Active | Straumann | |
|---|---|---|---|
| Material | Titanium | Titanium | Titanium alloy |
| Diameters | 3.8-5.0mm | 3.5-4.3 mm | 4.1-4.8mm |
| Lengths | 8-16 mm | 10-15mm | 8-14mm |
| Form | Root form | Root form | Root form |
| Insertion | Self Tapping | Self Tapping | Self tapping |
NON-CLINICAL TEST 5.
Static and dynamic compression performance test was conducted per ISO 14801:2007- Dentistry-Implants- Dynamic fatigue test for Endosseous Dental implants.
The worst case scenario was chosen based on the FDA guideline "Class 11 Special Controls Guidance Document: Root- form for Endosseous dental implants and Endosseous dental Implant Abutments".
Fatique test of the longest implant(16mm) in combination with the highest angled abutment(30°) was conducted.
The results of this testing indicate that the SATURN Dental Implant System is equivalent to the predicate devices cited in this submission.
CLINICAL TEST 6.
Clinical Evaluation of SATURN Dental Implant System Case Reports: Long-term results of several patients implanted with the SATURN Dental Implant System were presented and support the biomechanical theory concerning the loading on the implant. The implant wing reduces the pressure on the implant neck resulting in less absorption in the neck. The cases presented in this report show no bone loss in the neck of the implanted SATURN.
CONCLUSION 7.
The results of the testing conducted on the Saturn Dental Implant System demonstrated that the system is substantially equivalent to the named predicated devices in terms of functional, mechanical properties, indications for use and material.
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 17, 2014
Cortex Dental Implants Industries Ltd. C/O Mrs. Simha Sibony Regulatory Affairs and QA Consultant Qualitech P.O.Box 12082 Nahariya 2201202 ISRAEL
Re: K131258
Trade/Device Name: SATURN Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: February 10, 2014 Received: February 14, 2014
Dear Mrs. Sibony:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 -- Mrs. Sibony
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/Medica|Devices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Clinical Deputy Director
DAGRID
FOR
Erin 1. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Cortex Dental Implants Industries Ltd 510k Premarket Notification- SATURN Dental Implant System
Indications for Use
510(k) Number (if known): K131258
Device Name: SATURN Dental Implant System
Indications for Use:
The SATURN Dental Implant System is intended for surgical placement in the maxillary and/or the mandibular arch, to support crowns, bridges, or over dentures, in edentulous or partially edentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.
The System is intended to be used in either single tooth or multiple teeth restoration for immediate loading after extraction when good primary stability is achieved and with appropriate occlusal loading .
The procedure can be accomplished in a one-stage or two-stage surgical operation.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | AND/OR |
| Over-The-Counter Use | |
| (21 CFR 807 Subpart C) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary S. Runner -
S
Sucan Runna DDS, MA 2014.03.17
07:39:56 -04'00'
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