(30 days)
P.004 Healing Abutments and Closure Screws are intended for use with the Straumann P.004 Bone Level Implant system to protect the inner configuration of the implant. Healing Abutments have a secondary function to maintain, stabilize and form the soft tissue during the healing process.
The Straumann 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 device covered in this submission is healing abutments and closure screws. Healing abutments and closure screws are used to protect the inner configuration of the implant and to maintain, stabilize and form the soft tissue. Healing Abutments have a secondary function to maintain, stabilize and form the soft tissue during the healing process
This 510(k) premarket notification (K071585) is for dental healing abutments and closure screws. It does not contain information about a study proving device performance against acceptance criteria in the way a diagnostic AI/ML device submission would. Instead, it demonstrates substantial equivalence to a predicate device, which is the standard regulatory pathway for many medical devices.
Here's an analysis based on the provided document, addressing the requested points:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence)
This submission does not provide explicit quantitative acceptance criteria or a study demonstrating the device meets them in terms of performance metrics (like sensitivity, specificity, accuracy). Instead, the demonstration of equivalence relies on qualitative comparisons to a predicate device.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Claimed Equivalence) |
|---|---|
| Intended Use: Identical to predicate device. | P.004 Healing Abutments and Closure Screws: Intended for use with Straumann P.004 Bone Level Implant system to protect inner implant configuration and, for healing abutments, to maintain, stabilize, and form soft tissue during healing process. (Identical to predicate: P.004 RC Healing Abutments, K062129, and P.004 RC Closure Screws, K062129) |
| Material Composition: Same as predicate device. | NC Healing Abutments and Closure Screws: Same material composition as currently marketed RC Healing Abutments and closure screws. |
| Basic Design: Same as predicate device. | NC Healing Abutments and Closure Screws: Same basic design as currently marketed RC Healing Abutments and closure screws. |
| Fundamental Operating Principles: Same as predicate device. | NC Healing Abutments and Closure Screws: Same fundamental operating principles as currently marketed RC Healing Abutments and closure screws. |
Study Details (Not Applicable for this Type of Submission):
For this specific device (dental abutments and screws), the regulatory pathway is substantial equivalence, not a performance study as would be expected for a diagnostic or AI/ML device. Therefore, the following points are not directly addressed in the provided document:
- Sample size used for the test set and the data provenance: Not applicable. Substantial equivalence is demonstrated through comparative analysis of device characteristics, not a clinical test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a test set is not established in this type of submission.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI/ML diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This device is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this submission is the characteristics and performance of the legally marketed predicate devices.
- The sample size for the training set: Not applicable. This device is not an AI/ML model that requires training data.
- How the ground truth for the training set was established: Not applicable.
Summary Explanation:
The document, K071585, is a 510(k) summary for Straumann USA's NC Healing Abutments and NC Closure Screws. The core of this submission is to demonstrate substantial equivalence to existing legally marketed predicate devices (P.004 RC Healing Abutments and P.004 RC Closure Screws, K062129).
Instead of presenting results from a performance study against specific acceptance criteria, the manufacturer satisfies regulatory requirements by showing that the new device:
- Has the identical intended use as the predicate device.
- Shares the same material composition.
- Possesses a basic design that is comparable.
- Operates on the same fundamental principles.
The FDA's review confirms this substantial equivalence, allowing the device to be marketed without requiring a new, extensive clinical trial as would be necessary for novel devices or those with significantly different characteristics or intended uses. The "study" in this context is the comparative analysis conducted by the manufacturer and reviewed by the FDA to ascertain these equivalences.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)