(76 days)
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No
The summary describes a physical dental implant system and its components, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is a dental implant system used for restoration and fixation in patients, which are therapeutic functions.
No
The device description indicates it is a dental implant system used for restoration and fixation, not for diagnosing medical conditions.
No
The device description explicitly states that the system consists of physical components including dental implants, surgical and laboratory instruments, and prosthetic components. It is a hardware-based medical device system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- FRIALIT®-2 Dental Implant System: This device is a dental implant system. It is surgically implanted into the human body to replace missing teeth or support dentures. It does not involve the testing of specimens taken from the body.
The description clearly indicates it's a device for surgical implantation and prosthetic restoration, which falls under the category of medical devices used in vivo (within the body).
N/A
Intended Use / Indications for Use
The FRIALIT®-2 Dental Implant System is indicated for use in single tooth restoration, edentulous spans restored with multiple single teeth, freestanding bridges and to retain overdentures. The implants can be used for immediate implant placement, delayed immediate or late implant placement.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The FRIALIT®-2 Dental Implant System consists of subgingival threaded dental implants in 3.4 - 6.5mm diameters with 8 - 15mm lengths. The implants are coated with the FRIADENT Surface M2.1. The FRIALIT®-2 Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for single stage procedures for single tooth replacement, fixation of bridges and complete dentures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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)
Performance evaluations of the FRIALIT®-2 dental implant system show that the device performs as intended.
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.
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.
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AUG 1 4 2003
FRIADENT GmbH FRIALIT®-2 Dental Implant System Special Premarket 510(k) Notification
SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 17:
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 17.1
| a. Company Name: | FRIADENT GmbH. |
|---|---|
| b. Company Address: | Steinzeugstrasse 50 |
| Mannheim D-68229 | |
| Germany | |
| c. Company Phone: | |
| Company Facsimile: | (011) 49 621 43 02 1121 |
| (011) 49 621 43 02 2121 | |
| d. Contact Person: | Heike Dietzler |
| Regulatory Affairs Manager | |
| e. Date Summary Prepared: | May 27, 2003 |
17.2. DEVICE IDENTIFICATION
| a. Trade/Proprietary Name: | FRIALIT®-2 Dental Implant System |
|---|---|
| b. Classification Name: | Endosseous Dental Implants |
21 CFR 872.3640
17.3 IDENTIFICATION OF PREDICATE DEVICES
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| FRIADENT GmbH | FRIALIT®-2 Dental | ||
| Implant System | K945847 | 03/15/1996 | |
| FRIADENT GmbH | FRIALIT®-2 Dental | ||
| Implant System | K974358 | 10/02/1998 | |
| FRIADENT GmbH | FRIALIT®-2 Dental | ||
| Implant System | K994376 | 03/24/2000 |
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17.4 DEVICE DESCRIPTION
The FRIALIT®-2 Dental Implant System consists of subgingival threaded dental implants in 3.4 - 6.5mm diameters with 8 - 15mm lengths. The implants are coated with the FRIADENT Surface M2.1. The FRIALIT®-2 Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for single stage procedures for single tooth replacement, fixation of bridges and complete dentures.
SUBSTANTIAL EQUIVALENCE 17.5
The FRIALIT®-2 dental implants with the FRIADENT Surface M2.1 are substantially equivalent to the current FRIALIT®-2 Dental Implant Systems in terms of design, materials, mechanical strength, prosthetic and laboratory options and intended use.
INTENDED USE 17.6
The FRIALIT®-2 Dental Implant System is indicated for use in single tooth restoration, edentulous spans restored with multiple single teeth, freestanding bridges and to retain overdentures. The implants can be used for immediate implant placement, delayed immediate implant placement or late implant placement.
TECHNOLOGICAL CHARACTERISTICS 17.7
The FRIALIT®-2 dental implant is available in 3.4, 3.8, 4.5, 5.5 and 6.5 mm screw-type implants with the FRIADENT Surface M2.1. The lengths of the implants range from 8 - 15mm. The FRIALIT®-2 dental implants are constructed of CP-2 titanium. A variety of prosthetic options are available for the FRIALIT®-2 system including, AuroBase, CeraBase, MP, PassivFit, EstheticBase, TempBase, Gold Copings, Telescopic, Ball and Socket Attachments, Bar/Clip, and Select Abutments.
2
The FRIALIT®-2 dental implants with the FRIADENT Surface M2.1 is equivalent to the current FRIALIT®-2 Dental Implant System in terms of design, materials, mechanical strength, prosthetic options, instructions for use and intended use. The only difference is the change in the surface morphology of the dental implant to the FRIADENT Surface M2.1.
CLASS III CERTIFICATION AND SUMMARY 17.8
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.
17.9 CONCLUSIONS
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. Performance evaluations of the FRIALIT®-2 dental implant system show that the device performs as intended. Comparison the FRIALIT®-2 dental implant system to the predicate devices show that the device is substantially equivalent. The complete surface characterization of the new FRIADENT Surface M2.1 has been detailed in Device Master File MAF-1235.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, which is a common symbol of the United States.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 4 2003
FRIADENT GmbH C/O Carol Patterson Paterson Consulting Group Incorporated 21911 Erie Lane Lake Forest, California 92630
Re: K031674
Trade/Device Name: FRIALIT®-2 Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: August 7, 2003 Received: August 11, 2003
Dear Mr. Patterson:
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 - Mr. Patterson
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 (OS) 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 (301) 594-4613. 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/dsma/dsmamain.html
Sincerely yours,
Saser Runn
Susan Runner, DDS, MA Interim 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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FRIADENT GmbH FRIALIT®-2 Dental Implant System Special Premarket 510(k) Notification
INDICATION FOR USE
510(k) Number:
Device Name:
FRIALIT®-2 Dental Implant System
Indications for Use:
The FRIALIT®-2 Dental Implant System is indicated for use in single tooth restoration, edentulous spans restored with multiple single teeth, freestanding bridges and to retain overdentures. The implants can be used for immediate implant placement, delayed immediate or late implant placement.
Ken Muly fa. msn
ivision Sian-Off ion of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K031674
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use