(152 days)
The FRIADENT Implant systems (FRIALIT® plus Dental Implant System, XiVE® S plus Dental Implant System, XiVE® TG plus Dental Implant System, ANKYLOS® plus Dental Implant System) are for single-stage or two-stage surgical procedures and cemented or screw retained restorations. The FRIADENT Implant Systems are intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar.
The FRIADENT Implant Systems consist of root-formed threaded screws made from commercially pure titanium and coated with FRIADENT plus surface.
This submission (K073075) is for a Dentsply International dental implant system (FRIADENT Implant Systems) seeking to expand its indications for use to include immediate loading applications. The information provided heavily focuses on regulatory details and equivalency to predicate devices, rather than detailed performance study results that would typically be found in a clinical study report.
Therefore, the requested information for acceptance criteria and a study proving the device meets those criteria cannot be fully provided from the given text because the submission is primarily based on expanding indications for existing, legally marketed devices, and thus does not present new performance data in the typical format of a clinical trial.
The submission explicitly states: "No changes have been made to these implant systems. This submission expands the indications for use. Therefore, it was determined that no additional biocompatibility testing was necessary. We believe that the performance data provided and the research and development and marketing history of the unchanged device support the safety and effectiveness of the FRIADENT Implant Systems for the indicated uses."
This implies that the "acceptance criteria" are likely based on the historical performance and established safety and effectiveness of the existing implant systems for their original indications, and the "study" is the cumulative body of evidence from those existing devices and their marketing history, rather than a new dedicated study specifically proving immediate loading efficacy in a structured contemporary manner.
Given this context, I will address the requested points to the best of my ability, highlighting where the information is not present or implied by the nature of the submission.
Acceptance Criteria and Device Performance
Since this is an expansion of indications for existing devices, explicit, quantitative acceptance criteria and specific "reported device performance" from a new study designed to meet those criteria are not provided. The implicit acceptance criterion is that the devices, when used for immediate loading, maintain the safety and effectiveness demonstrated for their prior indications.
| Acceptance Criterion (Implicit) | Reported Device Performance (Implied) |
|---|---|
| Safety and effectiveness for immediate loading applications. | The submission states: "We believe that the performance data provided and the research and development and marketing history of the unchanged device support the safety and effectiveness of the FRIADENT Implant Systems for the indicated uses." This suggests that the historical performance data of the unchanged devices, across their original indications, is deemed sufficient to support the expanded use. |
| Compliance with existing regulatory standards. | The FDA's 510(k) clearance implies that the device meets the substantial equivalence requirements, meaning it is as safe and effective as existing legally marketed predicate devices, including for the expanded indications. |
| Good primary stability (for immediate placement and function). | This is a condition for the intended use: "when good primary stability is achieved, with appropriate occlusal loading." The device itself is designed to facilitate this, but the achievement of "good primary stability" is a clinical judgment for the user. |
Study Details (Based on the provided text):
As explained above, a dedicated "study" in the traditional sense (e.g., a new prospective, randomized controlled trial with detailed endpoints) proving the device meets new acceptance criteria for immediate loading is not detailed in this 510(k) summary. The submission relies on the existing performance data and marketing history of the unchanged devices.
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Sample size used for the test set and the data provenance: Not explicitly stated as a separate "test set" for new immediate loading performance. The "performance data" mentioned likely refers to cumulative clinical experience and studies related to the existing devices for their original indications. No details on country of origin or retrospective/prospective nature are provided for this cumulative data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of a new test set requiring expert ground truth for this submission. The safety and effectiveness determination is based on a regulatory review of existing data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication is described.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical dental implant, not an AI or imaging diagnostic tool, so MRMC studies are irrelevant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the expanded indications is indirectly derived from the outcomes data and clinical experience associated with the existing, unchanged FRIADENT implant systems over their documented marketing history. This historical performance, validated by clinicians in practice, serves as the basis for asserting safety and effectiveness when expanding indications.
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The sample size for the training set: Not applicable. This is not an AI or machine learning device that requires a training set.
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How the ground truth for the training set was established: Not applicable.
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510(k) SUMMARY
MAR 3 1 2008
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872
| CONTACT: | Helen Lewis |
|---|---|
| DATE PREPARED: | October 29, 2007 |
| TRADE OR PROPRIETARY NAME: | FRIADENT Implant Systems/Indication |
| CLASSIFICATION NAME: | Endosseous dental implant (21 CFR 872.3640) |
PREDICATE DEVICES:
Various Brånemark System Implants (K022562) Astra Tech Implants - Dental System (K041492)
DEVICE DESCRIPTION: The FRIADENT Implant Systems consist of root-formed threaded screws made from commercially pure titanium and coated with FRIADENT plus surface.
The indication for use of the FRIADENT Implant Systems includes the immediate loading applications on single tooth and/or multiple tooth applications recognizing sufficient bone stability (type I or II bone).
INTENDED USE: The FRIADENT Implant systems (FRIALIT® plus Dental Implant System, XiVE® S plus Dental Implant System, XiVE® TG plus Dental Implant System, ANKYLOS® plus Dental Implant System) are for single-stage or two-stage surgical procedures and cemented or screw retained restorations. The FRIADENT Implant Systems are intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in this submission have been used in legally marketed devices. No changes have been made to these implant systems. This submission expands the indications for use. Therefore, it was determined that no additional biocompatibility testing was necessary.
We believe that the performance data provided and the research and development and marketing history of the unchanged device support the safety and effectiveness of the FRIADENT Implant Systems for the indicated uses.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 2008
Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International, Incorporated Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872
Re: K073075
Trade/Device Name: FRIADENT Implant Systems (FRIALIT® plus Dental Implant System, XiVE® S plus Dental Implant System, XiVE® TG plus Dental Implant System, ANKYLOS® plus Dental Implant System) Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: February 28, 2008 Received: February 29, 2008
Dear Ms. Lewis:
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 vour 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. Lewis
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 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,
Suetia G. Michau Ouis.
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
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INDICATIONS FOR USE
510(k) Number (if known):
Device Name: FRIADENT Implant Systems (FRIALIT® plus Dental Implant System, XiVE® S plus Dental Implant System, XiVE® TG plus Dental Implant System, ANKYLOS® plus Dental Implant System)
Indications for Use:
The FRIADENT Implant systems (FRIALIT® plus Dental Implant System, XiVE® S plus Dental Implant System, XiVE® TG plus Dental Implant System, ANKYLOS® plus Dental Implant System) are for single-stage or two-stage surgical procedures and cemented or screw retained restorations. The FRIADENT Implant Systems are intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar.
Prescription Use __ X (Part 21 CFR 801 Subpart D) 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)
MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K073075
§ 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.