(247 days)
The Panthera Dental Milled Bar is indicated for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient for purpose of restoring chewing function. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained.
The Panthera Dental Milled Bars are indicated for compatibility with:
- · NobelActive: NP Ø3.5; RP Ø4.3 / Ø5.0; WP Ø5.5
- NobelParallel CC: NP Ø3.75: RP Ø4.3 / Ø5.0: WP Ø5.5
- NobelReplace: NP Ø3.5; RP Ø4.0 / Ø4.3 / Ø5.0; WP Ø5.0; 6 Ø6.0
- NobelSpeedy: RP Ø4.0 / Ø5.0; WP Ø5.0 / Ø6.0
- Brånemark: NP Ø3.3; RP Ø3.75 / Ø4.0; WP Ø5.0
The Panthera Dental Milled Bar is a metallic dental restorative device that is intended for attaching by screw retention to dental implants to aid in the treatment of partial and totally edentulous patients for the purpose of restoring chewing function.
The Panthera Dental milled bars for which clearance is requested, are included in one of the following bar types, which have distinct design specifications.
The Type I bars are specific for removable overdenture and include:
- . Panthera Dental Dolder Bar, Hader Bar, Milled Bar, REBourke Bar and Paris Bar.
The Type II bars are specific for fixed prostheses and include:
- Panthera Dental Wrap-around Bar, Montreal Bar, Montreal Bar with metallic lingual, Pin Lingual Bar and Pin Wrap-Around Bar.
The Panthera Dental Milled Bar is designed to match an individual patient. Panthera Dental designs the bar from a three-dimensional optical and/or digital scanner system that scans the patient's impression; the dental professional prepares the model cast beforehand. The designed bar is then machined using a computer-aided design/ computer-aided manufacturing (CAD/CAM) software system. The bar is milled from titanium (Ti-6AI-4V grade 5). CAD/CAM fabrication is only performed by Panthera Dental, within our manufacturing control and not by the dental laboratory.
The Panthera Dental Milled Bar is packaged as non-sterile, and delivered to a dental laboratory for completion. Once received at the laboratory, the Panthera Dental Milled Bar is matched to a denture for final placement. The Panthera Dental Milled Bar provides retention and support for a removable or fixed denture made of standard laboratory dental materials such as resin composite.
Here's a breakdown of the acceptance criteria and the study information for the Panthera Dental Milled Bars, based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly present acceptance criteria in a tabular format with specific numerical targets. Instead, it describes performance through compliance with recognized standards and successful testing outcomes. The "performance" is primarily demonstrated through meeting mechanical strength requirements and biocompatibility standards, and by showing substantial equivalence to a predicate device.
| Acceptance Criteria Category | Description of Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Strength | Meets the requirements for dynamic fatigue testing for endosseous dental implants. | The device (bar and cylinders) has the mechanical strength for its intended clinical application, as demonstrated by fatigue testing according to ISO 14801 and FDA guidance. |
| Biocompatibility | Biocompatible with tissue/bone/dentin for long-term contact. | Made from Titanium Ti-6Al-4V, a material used in the predicate. Cytotoxicity, extractable/leachable, toxicological risk assessment, and bacterial endotoxin testing compliant with ISO 10993-1, ISO 10993-5, ISO 10993-12, ANSI/AAMI ST72, and USP . |
| Sterilization | Can be effectively sterilized to a Sterility Assurance Level (SAL) of 10^-6. | Sterilization validation (Pre-vacuum steam sterilization) for the primary predicate was successful, demonstrating an SAL of at least 10^-6. The proposed device uses the same materials and sterilization cycle, therefore no additional testing was required. |
| Design Accuracy/Fit | Ensures a perfect fit and proper seating with compatible implant systems, with no possible interference. | Reverse engineering (RE) confirmed that the critical parameters of the design for interface connection, including tolerance limits, fall within the measured sizes of the Nobel Biocare counterparts. |
| Manufacturing Reliability | Manufacturing process is reliable and produces consistent results. | A process capability study conducted for the primary predicate (K173466) is valid for the proposed device, as the manufacturing process is identical. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample size for each test (e.g., how many bars were subjected to fatigue testing). It refers to "the bar itself" and "the bar cylinders" for fatigue testing. For reverse engineering, it mentions "each interface connection" and "each components per size and type" which implies multiple samples were analyzed to determine critical parameters and tolerance limits.
- Data Provenance: The document does not specify country of origin for data. The non-clinical testing was conducted by Panthera Dental Inc., a Canadian company. The tests are framed within the context of a 510(k) submission to the U.S. FDA. The testing conducted was for the primary predicate device (K173466) and determined to be applicable to the proposed device due to identical materials and manufacturing processes. The tests were retrospective in the sense that they were done on manufactured devices/components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: This information is not explicitly stated. The document refers to compliance with ISO and FDA guidance documents for testing, which implies a standard methodology rather than expert consensus on a subjective test set.
- Qualifications of Experts: Not specified. Testing was performed by Panthera Dental Inc. or their designated testing facilities to meet recognized standards.
4. Adjudication Method for the Test Set
Not applicable. The tests mentioned (fatigue, biocompatibility, sterilization, reverse engineering, process capability) are objective physical, chemical, and mechanical tests, not subjective evaluations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The Panthera Dental Milled Bars are a physical dental device, not an AI or imaging diagnostic tool that would typically involve a reader study.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical medical device, not an algorithm or software. The mention of CAD/CAM refers to the design and manufacturing process, not an independent algorithm performance.
7. Type of Ground Truth Used
The "ground truth" for the device's performance is established through:
- Compliance with recognized standards: ISO 14801 for fatigue testing, ISO 10993 series and USP for biocompatibility, and ANSI/AAMI-ST8 for sterilization.
- Measurement and verification: Reverse engineering to ensure precise fit with implant systems.
- Predicate device equivalence: Performance data for the predicate device (K173466) is directly applied due to identical materials, design principles, and manufacturing processes.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning or AI. The design and manufacturing processes are established based on engineering principles and validated through testing.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the context of this device. The design specifications and manufacturing parameters are established through engineering design, material science, and testing against industry standards, not via a machine learning training process.
§ 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.)