(28 days)
No
The summary describes a mechanical dental abutment and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as an abutment, which is a component placed into a dental implant to support prosthetic reconstructions. Its function is structural support for a prosthesis, not treatment or prevention of disease.
No
The device is described as an abutment, which is a component placed into dental implants to support prosthetic reconstructions. Its function is mechanical support, not to diagnose medical conditions or diseases.
No
The device description clearly states that the device is an abutment made from titanium, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the abutments are placed into dental implants to provide support for prosthetic reconstructions. This is a mechanical function within the body.
- Device Description: The description details the materials and how the abutment is placed and used to support a prosthetic. There is no mention of analyzing samples from the human body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis.
The device is a medical device used for structural support in dental restorations, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The devices covered by this submission are abutments which are placed into the dental implant to provide support for a prosthetic reconstruction. The subject abutments are indicated for cemented restorations, particularly in esthetic areas of the mouth. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The ITI Esthetic abutments are indicated for cemented restorations in esthetic areas of the mouth. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.
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 are abutments which are placed into the dental implant to provide support for a prosthetic reconstruction. The subject abutments are indicated for cemented restorations, particularly in esthetic areas of the mouth.
The ITI esthetic abutments are made from commercially pure Grade 4 titanium (ASTM F67) with a titanium alloy screw. The basal portion of the abutment has conical taper with an inset octagonal design. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutment is available in two diameters for use with ITI implants with shoulder diameters of 4.8 mm and 6.5 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental implants
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)
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
KO20096
FEB 0 8 2002
ATTACHMENT 6 - 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: Contact Person: Linda Jalbert Director, Requlatory Affairs
2. Name of the Device
| Trade Name: | ITI Esthetic Ease Abutments |
|---|---|
| Common Name: | Dental implant abutment |
| Classification Name: | Endosseous dental implants |
| 21 CFR 872.3640 |
Devices to which Equivalence is Claimed Legally Marketed 3. (Predicate Devices)
ITI synOcta Abutment (K990342) ITI Wide Neck Implant synOcta Abutment (K013798)
Description of the Device 4.
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 are abutments which are placed into the dental implant to provide support for a prosthetic reconstruction. The subject abutments are indicated for cemented restorations, particularly in esthetic areas of the mouth.
The ITI esthetic abutments are made from commercially pure Grade 4 titanium (ASTM F67) with a titanium alloy screw. The basal portion of the abutment has conical taper with an inset octagonal design. The abutment is placed over the implant shoulder and is mounted into the implant with a
1
screw. The abutment is available in two diameters for use with ITI implants with shoulder diameters of 4.8 mm and 6.5 mm.
Intended Use of the Device 5.
The devices covered by this submission are abutments which are placed into the dental implant to provide support for a prosthetic reconstruction. The subject abutments are indicated for cemented restorations, particularly in esthetic areas of the mouth. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.
6. Basis for Substantial Equivalence
The ITI esthetic abutments are substantially equivalent in intended use, material, and design to the ITI synOcta abutments cleared under K990342and ITI Wide Neck Implant synOcta abutments cleared under K013798.
ITI synOcta Esthetic Abutments 01/10/02 Page 23 of 26
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 8 2002
Institut Straumann AG C/O Ms. Linda Jalbert Director of Regulatory Affairs Straumann USA 1601 Trapelo Place Waltham, Massachusetts 02451
Re: K020096
Trade/Device Name: ITI Esthetic Abutments Regulation Number: 872.3640 Regulation Name: Dental Implant System Regulatory Class: III Product Code: DZE Dated: January 9, 2002 Received: January 11, 2002
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. or the Act of ally I outsial title Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and instills (21 es read in the quality systems (QS) regulation (21 CFR Part 820); and if requirence 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 your of your 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 If you desire pp. 11 CFR 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 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Timothy 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):
Device Name: ITI Esthetic Abutments
Indications For Use:
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The ITI Esthetic abutments are indicated for cemented restorations in esthetic areas of the mouth. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.
(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)
R. A. Ulatra A.
Division Sign-Off) ് vision of Dental, Infection Control, ം General Hospital Devices 110(k) Number ________________________________________________________________________________________________________________________________________________________________
ITI synOcta Esthetic Abutments 01/10/02 Page 26 of 26