(101 days)
Not Found
No
The document describes a dental implant and its intended use, contraindications, and modifications (new sizes). There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is a dental implant intended to restore chewing function, which is a structural rather than a therapeutic purpose.
No
The device is a dental implant intended to restore chewing function, not to diagnose a medical condition.
No
The device description clearly states it is a dental implant system, which is a physical hardware device. The summary does not mention any software component as the primary medical device.
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 surgical procedure for placing dental implants to restore chewing function. This is a medical device used in vivo (within the body), not in vitro (outside the body) for diagnostic purposes.
- Device Description: The description details the physical characteristics of a dental implant, which is a physical object implanted into bone.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information.
Therefore, the SPI® Dental Implant, ELEMENT is a medical device, specifically a dental implant, and not an IVD.
N/A
Intended Use / Indications for Use
SPI® Dental Implant, ELEMENT is for one-stage or two-stage surgical procedures. SPI Dental Implant, ELEMENT is intended for immediate placement and function on singletooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases.
Contraindications for the use of SPI ELEMENT implant Ø 3.5 mm: These implants are not suitable for applications in areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending movements.
- Restoration of posterior teeth in the upper and lower jaw .
- Single-tooth restoration of canines and central incisors in the upper jaw .
- Any application involving retentive anchors .
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The design of the Thommen Medical AG SPI® Dental Implant System implants has been modified to include new sizes and corresponding abutments that will be marketed as the SPI® Dental Implant, ELEMENT. All features other than these implant sizes remain the same as the currently marketed SP1® ELEMENT implants. Other components of the SP10 Dental Implant System have not been modified, are suitable for use with the modified implants, and will be sold under the SPI Dental Implant System name.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): 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.
K090154, K051502, K050712, K050258, K033984, K010185, K926501
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.
Not Found
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).
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
MAR - 4 2010
510(k) Summary Thommen Medical AG SPI® Dental Implant, ELEMENT February 25, 2010
ADMINISTRATIVE INFORMATION
Manufacturer Name:
Thommen Medical AG Hauptstrasse 26d CH-4437 Waldenburg, Switzerland +41 61 965 90 20 Telephone: +41 61 965 90 21 Fax:
Official Contact:
Orlando Antunes
Representative/Consultant:
Linda K. Schulz or Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: +1 (858) 792-1235 +1 (858) 792-1236 Fax:
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name:
Classification Regulations:
Product Code
Classification Panel: Reviewing Branch:
SPI® Dental Implant, ELEMENT Endosseous dental implant; Endosseous dental implant abutment 21 CFR 872.3640 21 CFR 872.3630 DZE NHA Dental Products Panel Dental Devices Branch
INTENDED USE
SPI® Dental Implant, ELEMENT is for one-stage or two-stage surgical procedures. SPI Dental Implant, ELEMENT is intended for immediate placement and function on singletooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases.
1
Contraindications for the use of SPI ELEMENT implant Ø 3.5 mm: These implants are not suitable for applications in areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending movements.
- Restoration of posterior teeth in the upper and lower jaw .
- Single-tooth restoration of canines and central incisors in the upper jaw .
- Any application involving retentive anchors .
DEVICE DESCRIPTION
The design of the Thommen Medical AG SPI® Dental Implant System implants has been modified to include new sizes and corresponding abutments that will be marketed as the SPI® Dental Implant, ELEMENT. All features other than these implant sizes remain the same as the currently marketed SP1® ELEMENT implants. Other components of the SP10 Dental Implant System have not been modified, are suitable for use with the modified implants, and will be sold under the SPI Dental Implant System name.
EQUIVALENCE TO MARKETED DEVICES
Thommen Medical AG demonstrated that, for the purposes of FDA's regulation of medical devices, the SPI Dental Implant, ELEMENT is substantially equivalent in indications and design principles to predicate devices (K090154, K051502, K050712, K050258. K033984, K010185, K926501), each of which has been determined by FDA to be substantially equivalent to preamendment devices. A comparison of the surface area of the Thommen Medical 6.5mm implant with that of a predicate short implant (Straumann Standard Implant 6.0 mm) showed that the Thommen Medical implant has a greater surface area than the predicate. Overall, the SPI Dental Implant, ELEMENT has the following similarities to the predicate devices:
- has the same intended use, .
- . uses the same operating principle,
- . incorporates the same basic design,
- . incorporates the same materials, and
- has similar packaging and is sterilized using the same materials and processes. .
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a flowing line representing the body.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Thommen Medical, AG C/O Ms. Linda K. Schulz Senior Regulatory Affairs Specialist Paxmed International, LLC 11234 EL Camino Real, Suite 200 San Diego, California 92130
MAR - 4 2010
Re: K093615
Trade/Device Name: SPI® Dental Implant, ELEMENT Regulation Number: 21CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product: DZE Dated: February 25, 2010 Received: February 1, 2010
Dear Ms. Schulz:
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.
3
Page 2- Ms. Schulz
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 Parl 801), please go to
http://www.ida.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.
h for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
4
SPI® Dental Implant, ELEMENT
510(k) Summary
Indications for Use
510(k) Number (if known):
Device Name: SPI® Dental Implant, ELEMENT
Indications for Use:
SPI® Dental Implant, ELEMENT is for one-stage or two-stage surgical procedures. SPI Dental-Implant, ELEMENT is intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases. .
Contraindications for the use of SPI ELEMENT implant Ø 3.5 mm:
These implants are not suitable for applications in areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending movements.
- Restoration of posterior teeth in the upper and lower jaw .
- Single-tooth restoration of canines and central incisors in the upper jaw .
- Any application involving retentive anchors .
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| RSBetz DDS for Dr. K. P. Muly | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| infection Control, Dental Devices | |
| 510(k) Number: | K093615 |