(7 days)
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No
The document describes a standard dental implant and does not mention any AI or ML components or functionalities.
Yes
The device is an implant that provides support for crowns, bridges, or overdentures, which are used to restore or replace missing teeth, thus providing a therapeutic benefit.
No
The device, a dental implant, is intended for structural support of crowns, bridges, or overdentures, not for diagnosing medical conditions.
No
The device description clearly states it is a root form endosseous dental implant made of titanium, indicating it is a physical hardware device.
No, 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 and Intended Use: The provided information clearly describes a dental implant that is surgically placed in bone to support dental prosthetics. This is a surgical device used directly in the body, not a test performed on a sample outside the body.
The description focuses on the physical characteristics of the implant and its surgical placement and function, which are not related to in vitro testing.
N/A
Intended Use / Indications for Use
The Thommen SPI® ELEMENT Dental Implant is intended to be surgically placed, either immediately after extraction or following healing, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. SPI® Dental Implants can be loaded immediately if they are splinted with a bar on four implants in the mandibular arch or six implants in the maxillary arch.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The Thommen SPI® ELEMENT Platform Ø 4.0 mm is a root form endosseous dental implant made of commercially pure grade 4 titanium. The implant surface is smooth machined on the transgingival portion and sandblasted and acid-etched in the area designed to contact bone.
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
maxillary and/or mandibular arch
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): 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.
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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
Ko70007
510(k) Summary
JAN 1 0 2007
Special 510(k): Device Modification
SPI® ELEMENT Platform Ø 4.0 mm
ADMINISTRATIVE INFORMATION
Sponsor Name: Thommen Medical AG I-aupstrasse 26d CH-4437 Waldenburg, Switzerland Telephone: +41 61 965 90 20 Fax: +41 61 965 90 21 Official Contact: Orlando Antunes Representative/Consultant: 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
DEVICE NAME
Classification Name:
Trade/Proprietary Name: Common Name:
Implant, Endosseous, Root-Form Abutment, Implant, Dental, Endosseous SPI® ELEMENT Platform Ø 4.0 mm Dental implant
ESTABLISHMENT REGISTRATION NUMBER
The Establishment Registration number for Thommen Medical AG is 3003836985. The Owner/Operator number is 9051144.
DEVICE CLASSIFICATION
FDA has classified endosseous dental implants and abutments as Class II devices (21 CFR 872.3640 and 21 CFR 872.3630). The product code for Implant, Endosseous, Root-Form is DZE and the product code for "Abutment, Implant, Dental, Endosseous" is NHA.
1
INTENDED USE
The Thommen SPI® ELEMENT Dental Implant is intended to be surgically placed, either immediately after extraction or following healing, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures, SPI® Dental Implants can be loaded immediately if they are splinted with a bar on four implants in the mandibular arch or six implants in the maxillary arch.
CONFORMANCE WITH PERFORMANCE STANDARDS
No performance standards applicable to endosseous dental implants have been established by FDA. The SPI ELEMENT dental implants meet the chemical requirements of ASTM F 67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700) and ISO 5832-2 Implants for surgery --Metallic materials -- Part 2: Unalloved titanium.
DEVICE DESCRIPTION
The Thommen SPI® ELEMENT Platform Ø 4.0 mm is a root form endosseous dental implant made of commercially pure grade 4 titanium. The implant surface is smooth machined on the transgingival portion and sandblasted and acid-etched in the area designed to contact bone.
PACKAGING/LABELING/PRODUCT INFORMATION
Thommen SPI® ELEMENT Platform Ø 4.0 mm will be packaged in a radiation sterilizable package consisting of a primary container, with implant and auxiliary parts, sealed with a peel-off wrapping. Sterilization will be accomplished by means of Co " gamma irradiation at a nominal dose of 25 kGy (2.5 Mrad).
EQUIVALENCE TO MARKETED PRODUCT
The SP1® ELEMENT Platform Ø 4.0 mm has the following similarities to the predicate SP10 ELEMENT Dental Implant:
- · has the same intended use.
- · uses the same operating principle,
- · incorporates the same basic design, (with the addition of a new platform diameter),
- · incorporates the same materials, and
- · is packaged and sterilized using the same materials and processes.
In summary, the Thommen SPI® ELEMENT Platform Ø 4.0 mm described in this submission is, in our opinion, substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design, possibly representing a human figure or a symbol of care and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the design, indicating the organization's name and country.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 2009 נוע
Thommen Medical, AG C/o Mr. Floyd G. Larson President PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
Re: K070007
Trade/Device Name: SPI® ELEMENT Platform Ø 4.0 mm Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: December 29, 2006 Received: January 3, 2007
Dear Mr. Larson:
This letter corrects our substantially equivalent letter of January 10, 2007.
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 (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 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-Mr. Larson
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 (QS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Purner
Susan Runner, D.D.S., MA
Acting 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
Applicant:
Thommen Medical AG
510(k) Number (if known):
SPI® ELEMENT Platform Ø 4.0 mm
Device Name:
Indications for Use:
The Thommen SPI® ELEMENT Dental Implant is intended to be surgically placed, either immediately after extraction or following healing, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. SPI® Dental Implants can be loaded immediately if they are splinted with a bar on four implants in the mandibular arch or six implants in the maxillary arch.
Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)
Susa Russo
of Anesthesiology, General Hospical, on Control, Dental Devices
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