(34 days)
Not Found
No
The 510(k) summary describes a system of dental implants and prosthetic accessories made of traditional materials like titanium and plastic, with no mention of AI or ML in the intended use, device description, or any of the technical sections.
No
The device components are described as prosthetic accessories (abutment, titanium temporary posts, plastic burnout copings, and titanium healing caps) designed to support prosthetic restorations and protect implants, rather than directly treating a disease or condition.
No
The provided text explicitly states the device's purpose is to provide support for prosthetic restorations and to protect implants during the healing phase, not to diagnose medical conditions.
No
The device description clearly states it is an "integrated system of endosseous dental implants" consisting of "dental implants, abutments, and surgical and prosthetic parts and instruments," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the devices are used in the mouth to support prosthetic restorations and protect the implant during healing. This is a direct interaction with the patient's body.
- Device Description: The devices are described as "endosseous dental implants" and "prosthetic accessories" that are part of a system for supporting prosthetic devices in patients.
- 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 outside the body to analyze biological samples. This device is used inside the body as a medical implant and its accessories.
N/A
Intended Use / Indications for Use
The abutment is placed into the dental implant to provide support for a prosthetic restoration such as a crown or bridge. The titanium temporary posts are screwed into the dental implants and serve as a base for a temporary prosthetic restoration. The plastic burn-out copings provide a cast inner surface for mating with the abutment and implant and are for use in casting restorations directly from porcelain- fused-to-metal alloy without the use of machined metal components. The healing cap and closure screw are titanium devices which are mounted onto the dental implant before the soft tissue is sutured in place around the implant and which are intended to protect the inner configuration of the implant. The healing cap also protects the outer 45° shoulder of the implant during the healing phase and helps stabilize and maintain the soft tissue.
Product codes
DZE
Device Description
The ITI Dental Implant System is an integrated system of endosseous dental implants which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments, and surgical and prosthetic parts and instruments. The devices covered by this submission include several prosthetic accessories (abutment, titanium temporary posts, plastic burnout copings, and titanium healing caps).
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)
K990342, K990342, K990342, K003271, K894844
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
DEC 1 9 2001
ATTACHMENT 6 - 510(k) Summary
1. Applicant's Name and Address
Straumann USA (on behalf of Institut Straumann AG) Reservoir Place 1601 Trapelo Road Waltham, MA 02451 781-890-0001 Telephone Number: Fax Number: 781-890-6464 Linda Jalbert Contact Person:
2. Name of the Device
Trade Name:
Common Name: Classification Name: Prosthetic Accessories to the ITI® DENTAL IMPLANT SYSTEM Endosseous dental implants Endosseous dental implants 21 CFR 872.3640
Director, Regulatory Affairs
3. to which Equivalence Claimed Legally Marketed Devices is (Predicate Devices)
ITI synOcta Abutment (K990342) ITI Temporary Posts (K990342) ITI Plastic Copings (K990342) ITI Healing Cap (K003271) ITI Closure Screw (K894844)
4. Description of the Device
The ITI Dental Implant System is an integrated system of endosseous dental implants which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments, and surgical and prosthetic parts and instruments. The devices covered by this submission include several prosthetic accessories (abutment, titanium temporary posts, plastic burnout copings, and titanium healing caps).
5. Intended Use of the Device
510(k) ITI® Dental Implant System 1 1/07/01 Page 38 of 42
1
The abutment is placed into the dental implant to provide support for a prosthetic restoration such as a crown or bridge. The titanium temporary posts are screwed into the dental implants and serve as a base for a temporary prosthetic restoration. The plastic burn-out copings provide a cast inner surface for mating with the abutment and implant and are for use in casting restorations directly from porcelain- fused-to-metal alloy without the use of machined metal components. The healing cap and closure screw are titanium devices which are mounted onto the dental implant before the soft tissue is sutured in place around the implant and which are intended to protect the inner configuration of the implant. The healing cap also protects the outer 45° shoulder of the implant during the healing phase and helps stabilize and maintain the soft tissue.
Basis for Substantial Equivalence 6.
The subject devices are substantially equivalent to previously cleared ITI abutments, temporary posts, burn-out copings, healing caps, and closure screws. The intended uses of the subject devices are identical to the predicate devices.
The subject devices have the same material composition as previously cleared ITI devices. In addition, the designs of the subject devices are similar to, and in some respects identical to, the previously cleared ITI devices.
510(k) ITI® Dental Implant System 11/07/01 Page 39 of 42
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized caduceus, featuring a staff with a serpent entwined around it, representing health and medicine. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 92001
Institut Straumann AG C/O Ms. Linda Jalbert Straumann USA Reservoir Place 1601 Trapelo Road Waltham, Massachusetts 02451
Re: K013798
Trade/Device Name: Prosthetic Accessories to the ITI Dental Implant System Regulation Number: Dental Implant Regulation Name: 872.3640 Regulatory Class: III Product Code: DZE Dated: November 7, 2001 Received: November 15, 2001
Dear Ms. Jalbert:
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.
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
3
Page 2 - Ms. Jalbert
of the Act or any Federal statutes and regulations administered by other Federal agencies. Of the Act of ally I ouchar stars requirements, including, but not limited to: registration Tourinust configry with and the rises ing (21 CFR Part 801); good manufacturing practice alle listing (21 OF R Pat 807), abolity 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 11ms letter will and w you is cognized and inding of substantial equivalence of your device to 310(K) promative nouricate 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 11 you dosire opveller FFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and Office of Confightance wee, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and the rior nay of obtained 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,
Timoth A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 1 of 1
510(k) Number (if known):
Prosthetic Accessories to the ITI® Dental Implant System Device Name:
Indications For Use:
The abutment is placed into the dental implant to provide support for a prosthetic restoration such as a crown or bridge. The titanium temporary posts are screwed into the dental implants and serve as a base for a temporary prosthetic restoration. The plastic burn-out copings provide a cast inner surface for mating with the abutment and implant and are for use in casting restorations directly from porcelain- fused-to-metal alloy without the use of machined metal components. The healing cap and closure screw are titanium devices which are mounted onto the dental implant before the soft tissue is sutured in place around the implant and which are intended to protect the inner configuration of the implant. The healing waren also protects the outer 45° shoulder of the implant during the healing phase and helps stabilize and maintain the soft tissue.
(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
(Optional Format 1-2-96)
. Blackwell for M.S. Rumer
(Division Sian-Off Division of Dental, Infection Control. and General Hospital Devic 510(k) Number .
510(k) ITI® Dental Implant System 11/07/01 Page 42 of 42