(88 days)
No
The 510(k) summary describes a dental implant system and its components. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text. The description focuses on the physical characteristics and intended use of the implant.
No.
The device is a dental implant system used for restoration and retention, which is a structural or prosthetic function rather than a therapeutic one.
No
Explanation: The device description states it is a dental implant system used for restoration. There is no mention of diagnostic functions or capabilities.
No
The device description explicitly details physical dental implants and associated surgical, prosthetic, and laboratory components, indicating it is a hardware-based medical device system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a dental implant system used for surgical placement in the mouth to support dental restorations. This is a medical device used in vivo (within the body).
- Device Description: The description details the physical characteristics of the implant and associated components, all of which are designed for surgical and prosthetic procedures within the patient's mouth.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests in vitro (outside the body) on biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The FRIALIT-2® 3.4mm Dental Implant is intended for use in single tooth restoration, edentulous spans restored with multiple single teeth, freestanding bridges and to retain overdentures. The implants can be used after extraction for immediate implant placement, delayed immediate implant placement or late implant placement.
The FRIALIT-2® Dental Implant System is intended for use in single tooth restoration, edentulous spans restored with multiple single teeth, free-standing bridges and to retain overdentures. The implants can be used after extraction for immediate implant placement, delayed immediate implant placement or late implant placement.
Product codes
DZE
Device Description
The FRIALIT-2® 3.4mm Dental Implant is an addition to the FRIALIT-2® Dental Implant System currently in commercial distribution. The FRIALIT-2® 3.4mm dental implant is available as a stepped cylinder coated with either FRIOS® TPS (titanium plasma sprayed) coating or FRIOS® HA (hydroxylapatite) coating, and a stepped screw-type implant line coated with the FRIOS® Deep Profile Surface. Surgical, prosthetic and laboratory components to facilitate the placement and restoration of the 3.4mm implant have also been designed.
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
The FRIALIT-2® 3.4mm dental implant is substantially equivalent to the Nobel BioCare Branemark 3.75mm dental implant in terms of 30° Compression/Bending Testing and Cyclic Loading Fatigue Testing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/2 description: The image shows a handwritten string of characters. The string starts with the letter 'K', followed by the number '994376'. The characters are written in a cursive style, with some of the strokes being thick and others thin.
SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 16:
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
SUBMITTER INFORMATION 16.1
| a. Company Name: | FRIADENT GmbH. |
|---|---|
| b. Company Address: | Steinzeugstrasse 50 |
| Mannheim D-68229 | |
| Germany | |
| c. Company Phone: | |
| Company Facsimile: | (011) 49 06 21 4 86 1549 |
| (011) 49 06 21 4 86 1866 | |
| d. Contact Person: | Birgit Unger |
| Quality Management and Regulatory Affairs | |
| e. Date Summary Prepared: | December 21, 1999 |
DEVICE IDENTIFICATION 16.2.
| a. Trade/Proprietary Name: | FRIALIT-2® 3.4mm Dental Implant |
|---|---|
| b. Classification Name: | Endosseous Dental Implants |
| 21 CFR 872.3640 |
16.3 IDENTIFICATION OF PREDICATE DEVICES
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Nobel BioCare | Branemark System Standard | ||
| 3.75mm Fixture | K925765 | 10/05/93 |
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FRIADENT GmbH FRIALIT-2® 3.4mm Dental Implant Original Premarket 510(k) Notification
DEVICE DESCRIPTION 16.4
The FRIALIT-2® 3.4mm Dental Implant is an addition to the FRIALIT-2® Dental Implant System currently in commercial distribution. The FRIALIT-2® 3.4mm dental implant is available as a stepped cylinder coated with either FRIOS® TPS (titanium plasma sprayed) coating or FRIOS® HA (hydroxylapatite) coating, and a stepped screw-type implant line coated with the FRIOS® Deep Profile Surface. Surgical, prosthetic and laboratory components to facilitate the placement and restoration of the 3.4mm implant have also been designed.
SUBSTANTIAL EQUIVALENCE 16.5
The FRIALIT-2® 3.4mm dental implant is substantially equivalent to the current FRIALIT-2® Dental Implant Systems in terms of design, materials, coatings and prosthetic options. The FRIALIT-2® 3.4mm dental implant is substantially equivalent to the Nobel BioCare Branemark 3.75mm dental implant in terms of 30° Compression/Bending Testing and Cyclic Loading Fatigue Testing.
The FRIALIT-2® 3.4mm dental implant is equivalent to the current FRIALIT-2® dental implants in design, materials, coatings, prosthetics, function and intended use. The FRIALIT-2® 3.4mm dental implant is equivalent to the Nobel BioCare Branemark 3.75mm dental implant in materials, functionality, mechanical strength and intended use.
16.6 INTENDED USE
The FRIALIT-2® 3.4mm dental implant is intended for use in single tooth restoration, edentulous spans restored with multiple single teeth, freestanding bridges and to retain overdentures. The implants can be used after extraction for immediate implant placement, delayed immediate implant placement or late implant placement.
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16.7 TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the FRIALIT-2® 3.4mm dental implant with the predicate devices is provided within this submission. The FRIALIT-2® 3.4mm dental implant is identical to the current FRIALIT-2® dental implants in terms of coatings, materials, prosthetic options and intended use. The FRIALIT-2® 3.4mm dental implant is available in a stepped cylinder with either FRIOS® TPS or FRIOS® HA coating, and as a stepped screw-type with FRIOS® Deep Profile Surface.
16.8 CLASS III CERTIFICATION AND SUMMARY
This notification contains a Class III certification and summary of adverse safety and effectiveness information pursuant to 513(f) of the Federal Food, Drug, and Cosmetic Act.
16.9 510(K) CHECKLIST
This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.
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Page 2 -Ms. Patterson
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Patuna Cincinta/xx
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 2000
FRIADENT GmbH C/O Ms. Carol Patterson Consultant Patterson Consulting Group, Inc. 21911 Erie Lane Lake Forest, California 92630
K994376 Re : FRIALIT-2® Dental Implant System Trade Name: Regulatory Class: III Product Code: DZE Dated: December 21, । ਰੇਰੇ ਰੋ Received: December 27, 1999
Dear Ms. Patterson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If vour device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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FRIADENT GmbH FRIALIT-2® 3.4mm Dental Implani Original Premarket 510(k) Notification
INDICATION FOR USE
K994376 510(k) Number
FRIALIT-2® Dental Implant System Device Name:
Indications for Use: The FRIALIT-2® Dental Implant System is intended for use in single tooth restoration, edentulous spans restored with multiple single teeth, free-standing bridges and to retain overdentures. The implants can be used after extraction for immediate implant placement, delayed immediate implant placement or late implant placement.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Suarez
(Division Sign-Off) Division of Dental, Infection Control, and General Hospita 510(k) Number
Prescription Use v
OR
Over-The-Counter Use
(Per 21 CFR 801 . 109)