(189 days)
SmileBond Systems Fast Bite Registration material is used for making impressions of the tech and gums of patients requiring enhancement of the smile and for bite alignment.
SmileBond System is a patented process for the delivery of dental bonding composites. The SmileBond process is indicated for both cosmetic enhancement of the smile, and functional improvement of the bite (or chewing system).
Fast-Set Bite Registration is a silicone impression material intended to be placed on an impression tray to reproduce the structures of the teeth and gums of patients requiring the enhancement of the smile and for bite alignment. The impression material is intended to be applied via a dual barrel cartridge system into an impression tray. The clear impression material is used in the lab to make an accurate impression of the final wax up. Once the impression material is set and slightly modified it is taken to the mouth for use in the transfer bonding process.
This 510(k) submission (K132599) concerns the "SmileBond System: Fast-Set Bite Registration Material," which is a dental impression material. The submission establishes substantial equivalence to existing predicate devices, rather than introducing a novel AI-powered diagnostic device.
Therefore, many of the requested categories related to AI performance, such as multi-reader multi-case studies, standalone algorithm performance, training/test set details, and expert adjudication of AI results, are not applicable to this type of device.
Here's the information that can be extracted and inferred from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For dental impression materials, acceptance criteria typically revolve around physical and mechanical properties, as well as biological compatibility. These are usually evaluated through laboratory testing following relevant ISO standards. However, the provided summary does not detail specific acceptance criteria or performance metrics (e.g., accuracy, tear strength, dimensional stability, working time, setting time).
Instead, the submission focuses on demonstrating substantial equivalence based on:
- Intended Use: Making impressions of teeth and gums for smile enhancement and bite alignment.
- Technological Characteristics: Silicone impression material, dual-barrel cartridge delivery, used with an impression tray.
- Comparison to Predicate Devices: Stating that the material is comparable to previously cleared silicone impression materials.
| Acceptance Criterion (Inferred from device type) | Reported Device Performance |
|---|---|
| Material Type | Silicone impression material |
| Delivery System | Dual-barrel cartridge system |
| Application Method | Applied into an impression tray |
| Purpose | Reproduces structures of teeth and gums for smile enhancement and bite alignment |
| Substantial Equivalence | Declared substantially equivalent to predicate devices (K801830 and K120013) based on intended use and technological characteristics. Implicitly meets the performance and safety profiles of these predicates. |
2. Sample Size Used for the Test Set and Data Provenance
Since this is a dental impression material, the "test set" would typically refer to samples of the material used in laboratory or potentially in-vivo/clinical performance studies (e.g., for physical properties, biocompatibility).
- The provided document does not specify sample sizes for any performance testing.
- Data Provenance: The document does not provide details on the origin of any performance data. The device is manufactured by Crown Delta under a previous 510(k) (K801380) for Millennium Company, suggesting that performance data, if generated, might refer to that previous clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable to a dental impression material. "Ground truth" in this context would refer to objective measurements of the material's properties (e.g., dimensional accuracy, tear strength) obtained through standardized laboratory tests, not expert consensus on diagnostic images.
4. Adjudication Method for the Test Set
- This is not applicable to a dental impression material. Adjudication is relevant for diagnostic interpretations, not for material property assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- This is not applicable as this is not an AI/diagnostic device that improves human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This is not applicable as this is not an AI/algorithm-based device.
7. The Type of Ground Truth Used
- For an impression material, the "ground truth" would be objective measurements of its physical and mechanical properties (e.g., working time, setting time, dimensional stability, elasticity, tear strength) typically established against ISO standards (e.g., ISO 4823 for elastomeric impression materials). The provided document does not explicitly state which specific ground truth measurements were used, but it implicitly relies on the material meeting the standards established for its predicate devices by Crown Delta.
8. The Sample Size for the Training Set
- This is not applicable as this is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This is not applicable as this is not an AI/machine learning device.
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).