(30 days)
SPI® CONTACT Platform Ø 4.0 mm 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. SPT® 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.
The design of the SPI CONTACT System has been modified to add an additional implant, with a platform diameter of 4.0 mm, giving further enhanced flexibility.
This document is a 510(k) summary for a medical device modification, specifically for the "SPI® CONTACT Platform Ø 4.0 mm" dental implant.
Based on the provided text, there is no acceptance criteria or study data present that describes device performance against specific metrics.
Here's why and what information is missing:
- Table of acceptance criteria and reported device performance: This document is a premarket notification for a device modification, focusing on substantial equivalence to a predicate device. It does not contain a study demonstrating performance against specific acceptance criteria.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, and ground truth establishment for the training set: All of these elements are typically part of a detailed study report that would be submitted to demonstrate the safety and effectiveness of a device, especially for novel devices or significant modifications that impact performance. This 510(k) summary explicitly states that the device "incorporates the same basic design, incorporates the same materials, and is packaged using the same materials and processes" as the predicate. This suggests that extensive new performance studies were not deemed necessary for this specific submission, as the modification is to add an additional implant with a different platform diameter, implying that the fundamental performance characteristics are expected to be similar to the already cleared predicate.
Key points from the document indicating why this information is absent:
- "Special 510(k): Device Modification": This indicates a specific type of submission for modifications to devices already on the market. These often rely heavily on demonstrating that the change does not adversely affect safety or effectiveness, often by showing substantial equivalence to the original device.
- "EQUIVALENCE TO MARKETED PRODUCT" section: This section explicitly states the similarities to the unmodified predicate devices, including "has the same intended use," "uses the same operating principle," "incorporates the same basic design," and "incorporates the same materials."
- Conclusion: "In summary, the Thommen SPI® CONTACT Platform Ø 4.0 mm described in this submission is, in our opinion, substantially equivalent to the predicate devices." The FDA's letter (K072933) confirms this substantial equivalence determination.
Therefore, this document does not contain the information requested about acceptance criteria or specific study results because the regulatory pathway chosen (510(k) for a device modification based on substantial equivalence) did not require the submission of new clinical performance data to demonstrate the device meets new acceptance criteria. The approval is based on its similarity to an already approved predicate device.
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SPI® CONTACT Platform Ø 4.0 mm
510(k) Summary
Thommen Medical AG Special 510(k): Device Modification
SPI® CONTACT Platform Ø 4.0 mm
Fax: +1 (858) 792-1236 Email: flarson@paxmed.com NOV 】 5 2007
ADMINISTRATIVE INFORMATION
Manufacturer Name: Thommen Medical AG Haupstrasse 26d CH-4437 Waldenburg, Switzerland Telephone: +41 61 965 90 20 Fax: +41 61 965 90 21 Official Contact: Orlando Antunes Minna Buser Representative/Consultant: Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: +1 (858) 792-1235
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: SPI® CONTACT Platform Ø 4.0 mm Common Name: Endosseous dental implant; Dental implant abutment Classification Name: Implant, Endosseous, Root form: Abutment, Implant, Dental, Endosseous (21 CFR 872.3640, 872.3630), Class II Product Code DZE; NHA Classification Panel: Dental Products Reviewing Branch: Dental Devices
ESTABLISHMENT REGISTRATION
The Establishment Registration number for Thommen Medical AG is 3003836985. The Owner/Operator number is 9051144.
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INTENDED USE
SPI® CONTACT Platform Ø 4.0 mm 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. SPT® 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.
DEVICE DESCRIPTION
The design of the SPI CONTACT System has been modified to add an additional implant, with a platform diameter of 4.0 mm, giving further enhanced flexibility.
EQUIVALENCE TO MARKETED PRODUCT
The SPI CONTACT Platform Ø 4.0 mm has the following similarities to the unmodified predicate devices:
- · has the same intended use,
- · uses the same operating principle,
- · incorporates the same basic design,
- · incorporates the same materials, and
- · is packaged using the same materials and processes.
In summary, the Thommen SPI® CONTACT 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 shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring four abstract human figures in profile, with flowing lines representing their hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 5 2007
Thommen Medical, AG C/O Mr. Floyd G. Larson President PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
Re: K072933
Trade/Device Name: SPI® CONTACT Platform Ø 4.0 mm Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: October 15, 2007 Received: October 16, 2007
Dear Mr. Larson:
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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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 (Sections 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 cntitled, "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,
Neil R. Hyde
Chiu Lin, Ph.D. v 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
510(k) Number (if known):
Device Name:
SPI® CONTACT Platform Ø 4.0 mm
Indications for Use:
SPI® CONTACT Platform Ø 4.0 mm 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. SP1® 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 (Part 21 CFR 801 Subpart D) | X |
|---|---|
| ---------------------------------------------- | --- |
AND/OR
Over-The-Counter Use (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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K072933 |
|---|---|
| ---------------- | --------- |
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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.