(22 days)
The abutment is placed into the dental implant to provide support for a prosthetic restoration such as a crown or bridge. The copings and milling cylinders are used as part of the prosthetic restoration.
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 an abutment, copings, and milling cylinders.
The provided document is a 510(k) summary for a medical device clearance, specifically an abutment for dental implants. It does not contain any information about acceptance criteria or a study that proves the device meets those criteria, as it is not a diagnostic device or a device that requires performance metrics in the way implied by the request.
Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device. This means the manufacturer is asserting that the new device is as safe and effective as a device already on the market, rather than needing to prove its performance against specific acceptance criteria through a clinical study.
Therefore, I cannot provide the requested information from the given text.
To explain why the requested information isn't present:
- Acceptance Criteria & Reported Device Performance: This device is a mechanical component (an abutment for a dental implant). Its "performance" is implicitly tied to its structural integrity, biocompatibility, and functional fit, which are often addressed through material specifications, design comparisons, and potentially bench testing (mechanistic rather than clinical performance). The 510(k) summary states that the subject device has an "almost identical design" to the predicate, implying its performance should be similar.
- Sample Size (Test Set), Data Provenance, Number of Experts, Adjudication Method, MRMC Comparative Effectiveness Study, Standalone Performance, Type of Ground Truth, Training Set Size & Ground Truth Establishment: These points are all relevant to clinical studies evaluating the diagnostic accuracy or clinical effectiveness of a device, especially for AI/ML-driven or diagnostic/screening tools. This dental abutment is a prosthetic component, not a diagnostic or AI device, so these types of studies are not typically required for its clearance. The "study" here is the comparison to the predicate device, not a performance study as described in the request.
The core of this 510(k) submission is the statement: "The subject devices are substantially equivalent to previously cleared ITI abutments. The intended use of the subject abutment is identical to the predicate abutment. The subject device has an almost identical design as the predicate device. The labeling and instructions for use for both devices are the same." This is the basis for its clearance, not a detailed performance study with acceptance criteria.
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SEP 1 9 2002
ATTACHMENT 5 - 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: Fax Number: 781-890-6464 Contact Person: Linda Jalbert Director, Requlatory Affairs
2. Name of the Device
| Trade Name: | 1.5mm synOcta abutment |
|---|---|
| Common Name: | Endosseous dental implants |
| Classification Name: | Endosseous dental implants |
| 21 CFR 872.3640 |
3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices)
ITI synOcta Abutment and accessories (K990342)
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 an abutment, copings, and milling cylinders.
5. Intended Use of the Device
The abutment is placed into the dental implant to provide support for a prosthetic restoration such as a crown or bridge. The copings and milling cylinders are used as part of the prosthetic restoration.
510(k) 1.5mm synOcta August 27, 2002 Page 29 of 33
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Basis for Substantial Equivalence 6.
The subject devices are substantially equivalent to previously cleared ITI abutments. The intended use of the subject abutment is identical to the predicate abutment.
The subject device has an almost identical design as the predicate device. The labeling and instructions for use for both devices are the same.
510(k) 1.5mm synOcta August 27, 2002 Page 30 of 33
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing right, with flowing lines representing hair or clothing. The seal is black and white and appears to be a scanned image.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Linda Jalbert Director, Regulatory Affairs Straumann USA Reservoir Place 1601 Trapelo Road Waltham, Massachusetts 02451
SEP 1 9 2002
Re: K022859
Trade/Device Name: Abutment and Prosthetic Accessories to the ITI Dental Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: August 27, 2002 Received: August 28, 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 vour 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 of the Act or any Federal statutes and regulations administered by other Federal agencies.
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Page 2 – Ms. Jalbert
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 and additionally 21 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Russo
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
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.
(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)
Palmar Cucente
on of Anesthesiology, General Hospital, Infection Control, Dental Device
510(k) Number: 1022859
510(k) 1.5mm synOcta August 27, 2002 Page 33 of 33
§ 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.