(143 days)
ITT dental implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges or overdentures in edentulous or partially edentulous patients.
The All-in-One implants are screw and cylinder type dental implants made from CP titanium, Grade 4. They are available in various diameters and insertion lengths. The implants have the same rough surface as cleared ITI endosseous implants. The transmucosal part has a smooth machined surface to allow for the attachment of epithelial tissue.
The provided text describes a 510(k) summary for the ITI Dental Implant System, which is a medical device submission to the FDA. This type of document is used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.
However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The document primarily focuses on:
- Applicant and device identification.
- Declaration of substantial equivalence to previously cleared devices (K894593, K894595, K971578, K954512, K960288, K954347, K960417).
- Description of the device (materials, design, surfaces).
- Intended use (supporting crowns, bridges, or overdentures in edentulous or partially edentulous patients).
- FDA's response letter acknowledging the 510(k) submission and permitting market entry based on substantial equivalence.
Therefore, I cannot fulfill your request to describe acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.
For a 510(k) submission, the "proof" often comes from demonstrating that the device is substantially equivalent to a predicate device, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. While performance testing is usually conducted to support the substantial equivalence claim, the specifics of such tests (acceptance criteria, results, expert reviews, sample sizes) are not detailed here.
{0}------------------------------------------------
3/5/99
Image /page/0/Picture/1 description: The image shows a handwritten string of alphanumeric characters. The string appears to be "Ka83742". The characters are written in a cursive style with varying stroke thicknesses. The background is plain white.
ATTACHMENT 9 - 510(k) Summary
Applicant's Name and Address 1.
Straumann USA (on behalf of Institut Straumann AG) Reservoir Place 1601 Trapelo Road Waltham, MA 02451 781-890-0001 Telephone Number: 781-890-6464 Fax Number: Linda Jalbert, Director of Regulatory Affairs Contact Person:
Name of the Device 2. .
Trade Name: Common Name: Classification Name: ITI Dental Implant System® Dental Implant Endosseous Dental Implant (21 CFR 872.3640)
Legally Marketed Devices to which Equivalence is Claimed (Predicate 3. Devices)
ITI Dental Implants (K894593, K894595, K971578) Nobel Biocare Branemark Implants Lifecore Dental Implant (K954512, K960288) Implant Innovations (K954347, K960417)
4. Description of the Device
The All-in-One implants are screw and cylinder type dental implants made from CP titanium, Grade 4. They are available in various diameters and insertion lengths. The implants have the same rough surface as cleared ITI endosseous implants. The transmucosal part has a smooth machined surface to allow for the attachment of epithelial tissue.
Intended Use of the Device રું.
The ITI All-in-One Dental Implants are intended to be placed in the maxillary and/or mandibular arch to support crowns, bridges or overdentures in edentulous or partially edentulous patients.
Basis for Substantial Equivalence 6.
The modified ITI dental implants are substantially equivalent to ITI Dental Implants, the Nobel Biocare Branemark implants, Lifecore and Implant Innovations Dental Implants in intended use, material and design.
The modified ITI dental implants have the same intended use as the current ITI dental implants, the Nobel Biocare Branemark implants, Lifecore and Implant Innovations dental implants.
The modified ITI implants are composed of the same material and have the same surface as the cleared ITI dental implants. In addition, the design of the modified ITI implants is similar to the cleared ITI implants. The implant has a rough surface in contact with bone for osseointegration and a smooth titanium surface in contact with mucosa. The range of diameters and lengths of the modified implants are also similar to the commercially available Nobel Biocare Branemark, Lifecore (K960288) and Implant Innovations (K954347) implants.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines extending from them, resembling a bird or a symbol of movement and progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 1999
Institut Straumann AG C/O Ms. Linda Jalbert Director, Regulatory Affairs Straumann USA Reservoir Place 1601 Trapelo Road Waltham, Massachusetts 02451
Re : K983742 ITI Dental Implant System® Trade Name: Regulatory Class: III Product Code: DZE Dated: January 22, । ਭੇਰੇ ਰ Received: January 25, 1999
Dear Ms. Jalbert:
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 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 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) regulation (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 obligation you might have under sections 531 through 542 of
{2}------------------------------------------------
Page 2 - Ms. Jalbert
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) 594-4692. 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 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
Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use Statement
Device Name:
,
ITI Dental Implants
Indications for Use:
ITT dental implants are intended for surgical placement in the maxillary and/oular I II dental implants are mended for surgical placement in also handing and our partially edentulous patients.
Susan Runner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ 6482740
Prescription Use
(Per 21 CFR 801.109)
Prescription Use -------------------------------------------------------------------------------------------------------------------------------------------------------------
t
§ 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.