(78 days)
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No
The document describes a dental implant system made of titanium and focuses on surgical procedures, healing periods, and loading protocols. There is no mention of AI or ML technology in the intended use, device description, or any other section.
Yes
The device is described as "Dental Implants" intended "to restore chewing function," which clearly indicates a therapeutic purpose.
No
The document describes dental implants for restoring chewing function, not for diagnosing medical conditions.
No
The device description explicitly states it is a "root form, endosseous dental implant made of commercially pure grade titanium," which is a physical hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the SPI® System Dental Implants are "self tapping, root form, endosseous dental implants made of commercially pure grade titanium." These are physical implants placed within the body.
- Intended Use: The intended use is to "restore chewing function" by providing a base for dental restorations. This is a therapeutic and restorative function, not a diagnostic one performed on a sample outside the body.
The text describes a medical device used for surgical implantation and restoration, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
SPI® System Dental Implants are for one-stage or two-stage surgical procedures. SPI System Dental Implants are 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 SP1® ELEMENT implant Ø 3.5 mm and SP1® CONTACT 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
DZE
Device Description
Thommen SPI Dental Implants are self tapping, root form, endosseous dental implants made of commercially pure grade titanium. The intended use of the subject endosseous dental implants includes a six week healing period when conventional loading protocols are used, rather than the currently recommended twelve-week minimum healing period, as well as to permit immediate functional loading of single-tooth or multiple unit restorations when good primary stability is achieved.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
posterior teeth in the upper and lower jaw, canines and central incisors in the upper jaw
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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510(k) Summary
SPI® System Dental Implants
510(k) Summary
Thommen Medical AG SPI® System Dental Implants
ADMINISTRATIVE INFORMATION
Manufacturer Name:
Thommen Medical AG Hauptstrasse 26d CH-4437 Waldenburg, Switzerland Telephone: +41 61 965 90 20 Fax: +41 61 965 90 21
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 Fax: 1 (858) 792-1236 email: lschulz@paxmed.com flarson@paxmed.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name: Classification Regulations:
Product Codes Classification Panel: Reviewing Branch:
SPI® System Dental Implants Dental implant Endosseous dental implant 21 CFR 872.3640, Class II DZE Dental Products Panel Dental Devices Branch
INTENDED USE
SPI® System Dental Implants are for one-stage or two-stage surgical procedures. SPI System Dental Implants are 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.
DEC # 6 2007
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SPI® System Dental Implants
Contraindications for the use of SP1® ELEMENT implant Ø 3.5 mm and SP1® CONTACT 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
Thommen SPI Dental Implants are self tapping, root form, endosseous dental implants made of commercially pure grade titanium. The intended use of the subject endosseous dental implants includes a six week healing period when conventional loading protocols are used, rather than the currently recommended twelve-week minimum healing period, as well as to permit immediate functional loading of single-tooth or multiple unit restorations when good primary stability is achieved.
EQUIVALENCE TO MARKETED PRODUCT
Thommen Medical AG has demonstrated that, for the purposes of FDA's regulation of medical devices, the SPI System Dental Implants are substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 6 2007
Thommen Medical, AG C/O Ms. Linda K. Schulz Regulatory Affairs PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
Rc: K072649
Trade/Device Name: SPI® System Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: November 29, 2007 Received: November 30, 2007
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.
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. 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); 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 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,
Suite of Michigan Dms.
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
510(k) Premarket Notification
SPI® System Dental Implants
18/1
Indications for Use
510(k) Number (if known):
SPI® System Dental Implants Device Name:
Indications for Use:
SPI® System Dental Implants are for one-stage or two-stage surgical procedures. SPI System Dental Implants are 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 SP1® ELEMENT implant Ø 3.5 mm and SPT® CONTACT 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. -
Suen (Kusner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K072649
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)
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