(201 days)
The Straumann® CARES® Screw-retained Bridge and Straumann® CARES® Dolder® Bar are indicated for use as bars and bridges that attach to dental implants (Straumann RN (Reqular Neck) Ø4.8mm and WN (Wide Neck) Ø6.5mm) in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
The Straumann® CARES® Screw-retained Bridge is available in different sizes and spans and can be fitted on 2 to 16 implants.
The Straumann® CARES® Dolder® Bar is available in different sizes and spans and can be fitted on 2 to 10 implant.
Straumann® CARES® Screw-Retained Bridges and Straumann® CARES® Dolder® Bars are dental restorative devices intended to be attached directly to dental implants by basel screws. The Straumann CARES Screw-Retained Bridge and Straumann CARES Dolder Bar are designed with implant interfaces comparable to a single tooth abutment which are attached to a Straumann implant RN (Regular Neck) Ø 4.8 mm and WN (Wide Neck) Ø 6.5 mm.
The implant positions and oral situation are recognized by a scan of a dental master model with implant analogs and scanbodies. Based on the scan data, the dental technician selects the proper implant interfaces and designs the bar or bridge according to a dentist's prescription.
Once the Straumann CARES Screw-Retained Bridge or Straumann CARES Dolder Bar is designed, the digital dataset is sent to Straumann CADCAM by an internet connection where the bridge or bar is milled from a cobaltchromium-based blank.
Straumann CARES Screw-Retained Bridges and Straumann CARES Dolder Bars allow for individual customization regarding function and esthetics. They attach directly to Straumann dental implants. The device is intended to be finished into a bridge or overdenture using standard dental laboratory techniques and materials. The devices are CAD-derived, CAMproduced and have a scanner as its data source.
The milling blanks used for the manufacture of Straumann CARES Screw-Retained Bridge and Straumann CARES Dolder Bar are manufactured from a cobalt chromium base metal alloy, which has been tested and found biocompatible for its intended use. The cobalt chromium alloy meets the physical and mechanical requirements of ISO 22674, Dentistry - Metallic materials for fixed and removable restorations and appliances and ISO 9693, Metal-ceramic dental restorative systems.
The provided 510(k) summary for the Straumann® CARES® Screw-Retained Bridge and Straumann® CARES® Dolder® Bar describes non-clinical testing to demonstrate substantial equivalence to predicate devices. This submission focuses on material properties, biocompatibility, and mechanical performance rather than AI-driven insights or diagnostic accuracy. Therefore, many standard AI/ML study components, such as sample size for test/training sets, expert qualifications for ground truth, adjudication methods, and MRMC studies, are not applicable here.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and performance are presented in several tables within the document for different aspects of the device.
Table 1: Metallic Material Properties (Derived from Table 2 in document)
| Property | Unit | Acceptance Criteria with and without Thermal Treatment | Conclusion |
|---|---|---|---|
| Color | na | Silver gray | Passed |
| Density | g/cm³ | 8.3 | Passed |
| Solubility in water | mg/l | insoluble | Passed |
| Proof strength Rp0.2 | MPa | > 360 | Passed |
| Vickers hardness | HV10 | 260 | na |
| Elongation after fracture | % | > 2.0 | Passed |
| CTE (25-500°C) | 10-6 K-1 | 14.4 | na |
| Solidus | °C | 1320 | na |
| Liquidus | °C | 1420 | na |
Table 2: Ceramic Bonding Properties (Derived from Table 3 in document)
| Veneering Porcelain | Debonding/Crack-Initiation Strength $\tau_b$ [MPa] | Acceptance Criterion | Conclusion |
|---|---|---|---|
| Initial MC (GC) | > 25 MPa | N/A (implied from results) | Passed |
| IPS InLine (Ivoclar Vivadent) | > 25 MPa | N/A (implied from results) | Passed |
| HeraCeram (Heraeus Kulzer) | > 25 MPa | N/A (implied from results) | Passed |
| VM13 (Vita Zahnfabrik) | > 25 MPa | N/A (implied from results) | Passed |
Table 3: Biocompatibility Testing (Derived from Table 4 in document)
| Test Method | Biocompatibility Acceptance Criteria | Results |
|---|---|---|
| Cytotoxicity of extract |
§ 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.)