(189 days)
No
The summary describes a standard dental implant system with various components and materials, and the performance studies focus on mechanical strength, surface analysis, sterilization, and biocompatibility. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a dental implant system used to provide support for prosthetic devices, restoring chewing function, rather than directly treating a disease or condition for therapeutic purposes.
No
The device description and intended use clearly state that it is a dental implant system used for surgical and restorative applications to provide support for prosthetic devices, not to diagnose a condition or disease.
No
The device description clearly outlines physical components (implants, abutments, healing caps, etc.) and performance studies relate to material properties and mechanical testing, indicating 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 surgical and restorative applications within the bone of the jaw to support prosthetic devices. This is a direct medical intervention on the patient's body.
- Device Description: The description details a physical implant system (implants, abutments, etc.) designed to be surgically placed.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is a surgical implant used within the body for structural support.
N/A
Intended Use / Indications for Use
The SPI Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Product codes
DZE, NHA
Device Description
SPI Dental Implant System is an internal hex implant system which comes in 3.3, 3.7, 4.2, 5.0, and 6.0 diameter. The implants come in lengths of 8, 10, 11.5, 13 and 16. Both straight and angled abutments are available.
The implant is a conical shape one with a grit blasted and acid etched surface. Standard abutments, standard narrow abutments, standard shoulder abutments, standard wide shoulder abutments, multiunit abutments, ball attachments, healing caps and standard 15° and 25° abutments are included in the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper or lower jaw
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)
Dynamic fatigue testing according to ISO 14801 was conducted to determine the abutments are strong enough for their intended use. Surface analysis according to the FDA guidance document was done including SEM and EDS. Sterilization according to ISO 11137-1 and 11137-2 was conducted on the implants. Abutment steam sterilization was done according to ISO 17665-1 and ISO 17665-2. Package integrity testing according to ASTM F1929-12 and accelerated aging according to ASTM F1980-07 was conducted. Materials used in the product meet ASTM F136 and the biocompatibility was demonstrated by testing the cytotoxicity according to ISO 10993-5. Endotoxin testing according to USP 161 was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
January 31. 2018
MSI France Gerard Bouana 5 Rue des Halles Paris 75001 France
Re: K172240
Trade/Device Name: SPI Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: October 24, 2017 Received: November 2, 2017
Dear Gerard Bouana:
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.
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name SPI Dental Implant System
Indications for Use (Describe)
The SPI Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510k Summary January 29, 2018 SPI Dental Implant System K172240
Name and address: MSI Implants 5 Rue des Halles Paris 75001 France Contact Person: Gerard Bouana Phone Number: +6-52129536 Name of device: SPI Dental Implant System Classification Name: Endosseous dental implants CFR: 21 CFR 872.3640 Product Code: DZE, NHA
Device Description: SPI Dental Implant System is an internal hex implant system which comes in 3.3, 3.7, 4.2, 5.0, and 6.0 diameter. The implants come in lengths of 8, 10, 11.5, 13 and 16. Both straight and angled abutments are available.
The implant is a conical shape one with a grit blasted and acid etched surface. Standard abutments, standard narrow abutments, standard shoulder abutments, standard wide shoulder abutments, multiunit abutments, ball attachments, healing caps and standard 15° and 25° abutments are included in the system.
Indications for Use: The SPI Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Testing Summary: Dynamic fatigue testing according to ISO 14801 was conducted to determine the abutments are strong enough for their intended use. Surface analysis according to the FDA guidance document was done including SEM and EDS. Sterilization according to ISO 11137-1 and 11137-2 was conducted on the implants. Abutment steam sterilization was done according to ISO 17665-1 and ISO 17665-2. Package integrity testing according to ASTM F1929-12 and accelerated aging according to ASTM F1980-07 was conducted. Materials used in the product meet ASTM F136 and the biocompatibility was demonstrated by testing the cytotoxicity according to ISO 10993-5. Endotoxin testing according to USP 161 was conducted.
Predicate Device: GP Implants Spiral Shape Dental Implant System K162299 Reference Device: PALTOP Dental Implant System K112795
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Substantial Equivalence:
SPI Dental Implant System is substantially equivalent to Spiral Shape Dental Implant System in indications for use, materials, design, and fatigue performance.
| Company | SPI Dental Implant System | Spiral Shape Dental Implant System |
|---|---|---|
| Indications for Use | The Spiral Shape Dental implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. | |
| It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. | The Spiral Shape Dental implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. | |
| It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. | ||
| Implant Diameters | 3.3, 3.7, 4.2, 5, 6 | 3.3, 3.7, 4.2, 5, 6 |
| Implant Lengths | 8,10,11.5,13,16 (no 6 x 16) | 8,10,11.5,13,16 (no 6 x 16) |
| Material of devices included in the submission | Ti-6AL-4V ELI | Ti-6AL-4V ELI |
| Type of abutment and maximum angulation | Pre-manufactured of no more than 25° | Pre-manufactured of no more than 25° |
| Interface type/shape | Internal hex | Internal hex |
| MSI Device | GP Implants Device | |
|---|---|---|
| Spiral Shape Internal | ||
| Hex Implants | Diameters of 3.3, 3.7, | |
| 4.2, 5, and 6mm | Diameters of 3.3, 3.7, | |
| 4.2, 5, and 6mm | ||
| Cover screw | Cover screw | Cover screw |
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| Multi-Unit Abutments | Multi-unit abutments in heights of 1,2,3 and 4 mm | Multi-unit abutments in heights of 1,2,3 and 4 mm |
|---|---|---|
| Ball attachments | Ball attachments in heights of 1,2,3,4,5, and 6mm | Ball attachments in heights of 1,2,3,4,5, and 6mm |
| Healing Caps 4.5 diameter | Healing cap in 3,4,5,6 and 7mm height | Healing cap in 2 and 7mm height |
| Healing Caps 5.5 diameter | Healing cap in 2,3,4,and 5mm height | Healing cap in 2,3,4,5,6,and 7mm height |
| Standard Titanium Abutment | Standard Titanium Abutment with height of 7 and 9 mm | Standard Titanium Abutment with height of 7mm |
| Standard Narrow Abutment | Standard narrow abutment with heights of 7 and 9 mm | Standard narrow abutment with heights of 7, 9, and 11mm |
| Standard Shoulder Abutment | Standard shoulder abutment in heights of 1,3 and 4mm | Standard shoulder abutment in heights of 1,2,3 and 4mm |
| Standard Wide Shoulder Abutment | Standard Wide Shoulder Abutment with heights of 1,2,3,and 4mm | Standard Wide Shoulder Abutment with heights of 1,2,3,and 4mm |
| Standard 15° Abutment | Standard 15° Abutment with heights of 8, 12 and 13mm | Standard 15° Abutment with heights of 8, 12, and 13mm |
| Standard 25° Abutment | Standard 25° Abutment with heights of 9 and 12mm | Standard 25° Abutment with heights of 9 and 12mm |
Conclusion:
SPI Dental Implant System is substantially equivalent to GP Implants Spiral Shape Dental Implant System. They both have the same indications for use, are of the same material, and have internal hex connections. The abutments, healing caps, and angled abutments are offered in similar designs and heights. Performance testing demonstrates substantial equivalence to the identified predicate devices.