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510(k) Data Aggregation
(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.
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