(81 days)
Not Found
No
The device description and intended use describe a mechanical tool for bone removal, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes.
The device is intended to remove bone that has grown over the top of the implant during the integration period, which is a therapeutic intervention.
No
The device is described as a tool for removing overgrown bone from implants, which is a surgical or therapeutic function, not a diagnostic one.
No
The device description explicitly states the device consists of a "stainless steel drill guide" and a "drill," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The FRIALIT-2 Bone Profiler is a surgical tool designed to physically remove bone tissue that has grown over a dental implant. It is used directly on the patient's bone, not on a sample taken from the patient.
- Intended Use: The intended use clearly describes a surgical procedure, not a diagnostic test.
Therefore, based on the provided information, the FRIALIT-2 Bone Profiler is a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The FRIALIT-2 ® Bone Profiler is intended to be used for the removal of bone that has grown over the top of the implant during the integration period.
Product codes
DZE
Device Description
The FRIALIT-2 Bone Profiler is part of the FRIALIT-2 Dental Implant System. The Bone Profiler consists of a stainless steel drill guide. The drill is available in the same diameters as the FRIALIT-2 implant bodies. The Bone Profiler is designed to remove bone that has grown over the top of an implant during the integration period. The FRIALIT-2 Bone Profiler can be used in a standard latch handpiece or by hand in a lab handle.
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
Not Found
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.
0
Image /page/0/Picture/2 description: The image contains a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the digits '9', '3', '5', '6', and '0'. The digits are written in a cursive style, with some connections between them. The image has a white background.
SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 15:
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 15.1
15.2.
| 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: | October 18, 1999 |
| DEVICE IDENTIFICATION | ||
| a. Trade/Proprietary Name: | FRIALIT-2 Bone Profiler | |
| Accessories to the FRIALIT-2 Dental | ||
| Implant Systems | ||
| b. Classification Name: | Endosseous Dental Implants | |
| 21 CFR 872.3640 |
IDENTIFICATION OF PREDICATE DEVICES 15.3
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Implant Innovations Inc. | 3i Standard Threaded/ | ||
| Self-Tapping Threaded/ | |||
| 3i MiniPlant Systems | K960417 | 08/01/96 |
1
DEVICE DESCRIPTION 15.4
The FRIALIT-2 Bone Profiler is part of the FRIALIT-2 Dental Implant System. The Bone Profiler consists of a stainless steel drill guide. The drill is available in the same diameters as the FRIALIT-2 implant bodies. The Bone Profiler is designed to remove bone that has grown over the top of an implant during the integration period. The FRIALIT-2 Bone Profiler can be used in a standard latch handpiece or by hand in a lab handle.
ાર્ટનર SUBSTANTIAL EQUIVALENCE
The FRIALIT-2 Bone Profiler is substantially equivalent to the Implant Innovations, Inc., Bone Profiler of the 3i Standard Threaded/Self-Tapping Threaded Dental Implant Systems.
The fundamental technical characteristics of the FRIALIT-2 Bone Profiler are similar to those of the predicate. The FRIALIT-2 Bone Profiler is equivalent to the Implant Innovations, Inc., Bone Profiler in design, material, and function and intended use.
15.6 INTENDED USE
The FRIALIT-2 Dental Implant System is intended for single tooth restorations, edentulous spans restored with multiple single teeth, free-standing bridges and to retain overdentures. These implants can be used for immediate, delayed immediate or late implant placement.
2
15.7 TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the FRIALIT-2 Bone Profiler with the predicate device is provided within this submission. Both the FRIALIT-2 Bone Profiler and the predicate device are similar in design, materials and functionality. The FRIALIT-2 Bone Profiler is available in diameters corresponding to those of the implant bodies. The components are color-coded for ease of use.
15.8 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.
510(K) CHECKLIST 15.9
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.
3
Image /page/3/Picture/2 description: The image shows a logo for the Department of Health. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" arranged in a circular fashion around a symbol. The symbol consists of three curved lines that resemble a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 0 2000
Friadent GmbH Ms. Carol Patterson Consultant for Friadent GmbH Patterson Consulting Group, Incorporated 21911 Erie Lane 92630 Lake Forest, California
Re: K993560 FRIALIT-2 BONE PROFILER Accessory to the Trade Name: FRIALIT-2 Dental Implant System Requlatory Class: III Product Code: DZE Dated: October 18, 1999 October 21, 1999 Received:
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 aqainst misbranding and adulteration.
If your 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 requlation 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
4
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 premarket notification" (21 CFR 807.97). 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.
Timothy A. Ulatowski
Timothy A. ulat Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
.
ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
INDICATION FOR USE
| 510(k) Number: | K993560 |
|---|---|
| Device Name: | FRIALIT-2 ® Bone Profiler |
| Indications for Use: | The FRIALIT-2 ® Bone Profiler in intended to be used for the removal of bone that has grown over the top of the implant during the integration period. |
(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 | |
|---|---|
| ---------------------- | -- |
Susan Punno
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devic 99 556 510(k) Number _