(140 days)
Not Found
No
The summary describes a standard dental implant system made of titanium with different shapes and surface treatments. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is an implant used to replace missing teeth, which is a common therapeutic intervention in dentistry.
No
The device description clearly states "EASY GRIP dental implants are root-form endosseous dental implant devices," which are used for "attachment of complete denture prostheses or as a terminal or intermediary abutment for fixed or removable bridgework or as a free-standing single tooth replacement." These are therapeutic and restorative functions, not diagnostic ones.
No
The device description explicitly states that the device is made of biocompatible medical titanium and includes different types of implants, screws, and prosthetic components, indicating it is a physical hardware device.
Based on the provided information, 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 Description and Intended Use: The description clearly states that the EASY GRIP implants are dental implants designed to be surgically placed in the jawbone (mandibles or maxillae) to support dental prostheses. This is a device that is implanted into the body, not used to test samples taken from the body.
The information provided focuses on the physical characteristics of the implant, its surgical placement, and its function in supporting dental work. There is no mention of analyzing biological samples or providing diagnostic information.
N/A
Intended Use / Indications for Use
EASY GRIP implants are designed for use in partially edentulous mandibles or maxillae for attachment of complete denture prostheses or as a terminal or intermediary abutment for fixed or removable bridgework or as a free-standing single tooth replacement. EASY GRIP implant system uses a two-stage implantation procedure or one-stage procedure.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
EASY GRIP dental implants are root-form endosseous dental implant devices made out of biocompatible medical titanium, commercially pure or alloyed. There are three types of implants: cylindrical, anatomical, conical, available in different diameters from 3.3 to 5.5 mm and lenghts that vary from 8 to 16 mm. The anchorage surface of the implant is roughened by a sand-blasting and an acid-etching process, for better osseointegration. This submission also include compatible screws and prosthetic components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially edentulous mandibles or maxillae
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K033922, K984104, K003271, K012757, K030007, K031055, K050956, K041759, K041402, K063286, K022009, K040757, K061500, K013867, K021318, K024004
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.
Not Found
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).
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
510(k) NOTIFICATION
EASY GRIP
1672
MAY 1 4 2008
510 (k) Summary of safety and effectiveness
SUBMITTER INFORMATION
ಗಿ | Company Name: | I.F.I. System s.r.I. |
---|---|---|
B. | Company Address: | Via Alessandro D'Ancona, 23 |
Roma, Italy 00137 | ||
C. | Company Phone: | |
Company Fax: | +39 06 87201371 | |
+39 06 87232518 | ||
D. | Contact Person: | Claudio Mechelli |
Managing Director | ||
T.F.I. System s.r.I. |
- ய் Date Summary Prepared: December 20, 2007
DEVICE IDENTIFICATION
A. | Device name: | Endosseous Dental Implant System |
---|---|---|
B. | Trade/Proprietary Name: | EASY GRIP® dental implant system |
C. | Classification name: | Endosseous dental implant (21 CFR 872.3640) and |
Endosseous dental implant abutment (21 CFR 872.3630) | ||
D. | Product Code: | DZE |
E mail info@tfisystem.it
LEGALLY MARKETED DEVICES (PREDICATE DEVICES)
- Straumann USA & AG, ITI® Dental Implant Systems K033922, K984104, K003271, -K012757, K030007, K031055,
- Sudimplant SA, T.B.R.® ide@ conic, K050956, -
- ACE Surgical Supply Co., Inc., ACE CONNECT ™ Internal Connection Screw Dental " Implant System K041759,
- Implant Innovations, Inc., 3i Restorative Dental Implant Systems, K041402, K063286, -K022009.
- SIC Invent AG, SIC Dental Implant Systems, K040757, K061500, ・
- FRIADENT GmbH, XIVE® Dental Implant Systems, K013867, K021318, K024004 -
1
EASY GRIP
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DESCRIPTION OF THE DEVICE
EASY GRIP dental implants are root-form endosseous dental implant devices made out of biocompatible medical titanium, commercially pure or alloyed. There are three types of implants: cylindrical, anatomical, conical, available in different diameters from 3.3 to 5.5 mm and lenghts that vary from 8 to 16 mm. The anchorage surface of the implant is roughened by a sand-blasting and an acid-etching process, for better osseointegration. This submission also include compatible screws and prosthetic components.
INTENDED USE
EASY GRIP implants are designed for use in partially edentulous mandibles or maxillae for attachment of complete denture prostheses or as a terminal or intermediary abutment for fixed or removable bridgework or as a free-standing single tooth replacement. EASY GRIP implant system uses a two-stage implantation procedure or one-stage procedure.
SUBSTANTIAL EQUIVALENCE
EASY GRIP dental implant system and the predicate devices are similar in fundamental scientific technology in that they are all threaded, root form implants constructed of titanium with roughened surfaces. The subject and predicate devices use the same materials and are similar in size. In further support of a substantial equivalence determination, Section 5 provides a comparison chart of the Easy Grip implant system and the predicate devices.
Based on the available 510(k) summaries and the information provided herein, we conclude that Easy Grip implant system is substantially equivalent to the existing legally marketed devices under Federal Food, Drug and Cosmetic Act
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 2008
Mr. Claudio Mechelli Managing Director T.F.I. System Srl Via Alessandro D'Ancona, 23 00137 Roma ITALY
Re: K073622
Trade/Device Name: Easy Grip Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: April 18, 2008 Received: April 24, 2008
Dear Mr. Mechelli:
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.
3
Page 2 - Mr. Mechelli
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,
Clus
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
Enclosure
4
T.F.I. SYSTEM S.R.L.
510(k) NOTIFICATION
EASY GRIP
,"
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
EASY GRIP
Indications for Use:
EASY GRIP implants are designed for use in partially edentulous mandibles or maxillae for attachment of complete denture prostheses or as a terninal cr intermediary abutment for fixed or removable bridgework or as a free-standing single tooth replacement. EASY GRIP implant system uses a two-stage implantation procedure or one-stage procedure.
Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runoz
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: KC073622
EASY GRIP 510(k) Page 3-2