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510(k) Data Aggregation
(196 days)
CONTOUR HEALER
The Contour Healer Temporary Abutment is intended for use with a root-form endosseous dental abutment to aid in prosthetic rehabilitation. The abutment is a provisional restoration that aids in creating an esthetic emergence through the gingiva during the healing period. The device is for use by dental professionals for single restorations in adults. The device is for single-use only and may not be re-processed.
These abutments are designed to work with the following implant systems:
Zimmer [Screw-Vent Dental Implant System]
Nobel Biocare [Replace HA Coated Implant, Replace TiUnite Endosseous Impiant, Nobel Biocare Endosseous Implants, and Groovy Implants]
BioHorizons [BioHorizons·Tapered Internal Implant System].
The Contour Healer. LLC product line includes pre-manufactured dental abutments intended to serve as a temporary dental prosthesis during the healing process until a permanent crown is fabricated. The abutment is made of PEEK Classix and is directly connected to the endosseous dental abutment by a stainless steel screw.
These abutments have biconvex domes to mimic emergence of the original tooth morphology. and therefore provide for a more esthetic gingival contour during the restorative phase. The abutments come in several abutment- to-implant diameters. The abutments are intended for single-use not to exceedninety days. At the end of the treatment period, the temporary abutment is to be removed by clinician and the permanent crown is installed.
The provided text describes a 510(k) premarket notification for the Contour Healer Temporary Abutment. It explicitly states that formal clinical studies were not conducted on the device. Instead, the submission relies on bench testing, material conformity, and design validation studies by dental professionals to demonstrate substantial equivalence to a legally marketed predicate device (Zimmer Dental Plastic Temporary Abutment [K092377]).
Therefore, direct acceptance criteria for a study proving device performance in a clinical setting, as well as several of the requested study-specific details, are not applicable or cannot be extracted from this document, as no formal clinical study was performed.
Here's a breakdown of the available information based on the input:
1. Table of Acceptance Criteria and Reported Device Performance:
Since no formal clinical studies were conducted, there are no reported clinical performance metrics in terms of efficacy or safety from a comparative study with specific acceptance criteria. The device's performance is primarily assessed against design specifications, material properties, and a comparison to the predicate device for substantial equivalence.
| Parameter | Acceptance Criteria and Basis | Reported Device Performance (as demonstrated by testing) |
|---|---|---|
| Dimensional Specifications | Devices must meet all dimensional specifications. (Established through design and manufacturing processes). | First article inspections are done on each molding run to ensure devices meet all dimensional specifications. Routine inspections (100% of devices) ensure each temporary abutment meets design specifications. |
| Fit (Passive) | Correct passive fit of the temporary abutment into the corresponding implant analog. (Ensures compatibility and proper seating with implant systems). | Routine inspections include a check for correct fit (passive) of the temporary abutment into the corresponding implant analog. |
| Screw Fit | Correct screw fit into the temporary abutment. (Ensures secure attachment). | Routine inspections include a check for correct screw fit into the temporary abutment. |
| Visual Inspection | Absence of flash and debris. (Ensures product quality and safety). | Routine inspections include visual inspection of each piece for flash and debris. |
| Material Biocompatibility | Biocompatibility demonstrated per ISO 10993 standards for cytotoxicity, irritation, delayed contact hypersensitivity, and acute systemic toxicity. (Ensures material safety for biological contact). | Biocompatibility of the finished, sterilized temporary abutments was demonstrated per ISO 10993, covering cytotoxicity, irritation, delayed contact hypersensitivity, and acute systemic toxicity. |
| Stainless Steel Screw | Meets specified chemical analysis and 11 different performance specifications per standards. (Ensures strength and material integrity of the screw). | The stainless steel screws are purchased to specification and received with certification testing results for chemical analysis and 11 different performance specifications per standards. |
| Safety and Efficacy (User Validation) | No unexpected or device-related adverse events or complications. Product labeling is clear and appropriate for the intended use and indications. (User confirmation of practical safety and intended function). | Formal design validation studies performed by several dental professionals confirmed the safety and efficacy of the device design for the intended use and ensured clear and appropriate product labeling. No unexpected or device-related adverse events or complications were found in these studies. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: For the "design validation studies done by several dental professionals," the specific sample size (number of professionals or number of cases evaluated) is not provided.
- Data Provenance: The document does not specify the country of origin. The studies appear to be prospective design validation studies as a part of the device development and submission process, rather than retrospective analysis of existing data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: "Several dental professionals" were used for formal design validation studies. A specific number is not provided.
- Qualifications of Experts: The specific qualifications (e.g., years of experience, specialization) of these dental professionals are not provided. However, their professional role (dental professionals) suggests they are qualified to assess dental devices.
4. Adjudication Method for the Test Set:
- The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the design validation studies. The statement "no unexpected or device-related adverse events or complications were found" suggests qualitative feedback rather than a quantitative adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Formal clinical studies were not conducted on the device."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical dental abutment, not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm is not relevant here.
7. The Type of Ground Truth Used:
- For the design validation studies, the "ground truth" was essentially expert assessment/consensus of dental professionals regarding the device's safety, efficacy, and appropriate labeling in a practical, real-world context (though not a formal clinical trial).
- For the manufacturing and material testing, the "ground truth" was established by predetermined engineering specifications, dimensional tolerances, and ISO standards (e.g., ISO 10993).
8. The Sample Size for the Training Set:
- Not applicable. As this is a physical medical device and not an AI algorithm, there is no concept of a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. (See point 8).
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