(32 days)
The UCLA Abutments and Cement-On Abutments are designed for use with commercially available dental implant systems. These abutments are straight abutments and are NOT angled abutments. The abutments will seat directly on implants and are sub-structure of prosthesis. Some abutments are used as pattern in dental laboratory to make prosthesis, such as UCLA Plastic Cylinders.
All abutments have been designed specifically to be compatible and to be used with each of the following implant systems and sizes (for engineering drawings please refer to Attachment GG),
| IMPLANT COMPANIES | IMPLANT SYSTEMS | IMPLANT SIZE (mm) |
|---|---|---|
| Nobel Biocare | NobelPerfect | |
| Replace Select | 3.5, 4.3 & 5.0mm | |
| 3.5, 4.3, 5.0 & 6.0mm | ||
| Straumann | ITI | 3.5mm Shoulder Diameter |
| Narrow Neck Solid Screw | ||
| ITI | 4.8mm Shoulder Diameter | |
| Solid Screw | ||
| ITI | 6.5mm Shoulder Diameter | |
| Wide Neck Solid Screw | ||
| Dentsply/ Friadent | Frialit-2 | |
| XIVE | 3.4, 3.8, 4.5, 5.5 & 6.5mm | |
| 3.4, 3.8, 4.5 & 5.5mm | ||
| 3i | Osscotite Certain | 4.0, 5.0 & 6.0mm |
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I am sorry, but the provided text from the FDA 510(k) letter for the "UCLA and Cement-On Abutments and Accessories" does not contain the information requested about acceptance criteria or a study proving device performance.
This document is a letter from the FDA confirming that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. It states that the device has been reviewed and determined to be substantially equivalent based on the indications for use provided by the applicant.
The letter acknowledges the device's classification and lists general regulatory requirements (registration, labeling, good manufacturing practice, etc.). It does not include:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes for test sets or data provenance.
- Information on the number or qualifications of experts for ground truth.
- Adjudication methods.
- Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results from a standalone algorithm-only performance study.
- The type of ground truth used in any study.
- Training set sample sizes or how their ground truth was established.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This document is focused on regulatory clearance based on substantial equivalence, not on detailed performance study reports.
§ 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.