(11 days)
· Impressions of inlay, onlay, veneer, crown, and bridge preparations
· Fixation and implant impressions
RAPID HB, MB and LB are especially suitable for taking impressions of single-unit and double-unit preparations.
Rapid HB, Rapid LB and Rapid MB are a group of polyether impression materials of heavy, light and medium consistency used by dental professionals individually or in combination. Rapid HB and Rapid MB are mixed in the Pentamix mixing device, while Rapid LB can be applied directly using the Garant dispenser.
Rapid HB is a heavy bodied hydrophilic impression material used in one step technique. Thereby Rapid HB is used in combination with the light consistency wash material Rapid LB. Rapid HB is reddish-violet colored.
Rapid LB is a light bodied hydrophilic impression material used in one step technique. Thereby Rapid LB is used in combination with the higher consistency tray material Rapid LB is apple green colored.
Rapid MB is a medium bodied hydrophilic impression material used in mono-phase technique (Rapid MB as syringing and as tray material) and in one step technique (Rapid LB as syringing and Rapid MB as tray material). Rapid MB is blueish-violet colored.
The provided document describes the 510(k) premarket notification for the dental impression materials Rapid HB, Rapid LB, and Rapid MB. It outlines the non-clinical testing conducted to demonstrate substantial equivalence to predicate devices, focusing on meeting ISO 4823 standards and comparative performance.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on fulfilling the requirements of the FDA-recognized standard ISO 4823 and demonstrating similar performance to predicate devices. The document explicitly states: "In vitro testing was conducted to show that Rapid HB, Rapid LB and Rapid MB fulfils the requirements of FDA recognized standard ISO 4823." and "The results of Rapid LB and Rapid MB fulfill the requirements of ISO 4823 and are similar to Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB."
The specific metrics tested and their performance relative to acceptance criteria are summarized below:
| Acceptance Criteria (Based on ISO 4823 & Predicate Performance) | Reported Device Performance (Rapid HB, LB, MB) |
|---|---|
| Fulfill requirements of FDA recognized standard ISO 4823: Dentistry - Elastomeric Impression Materials | Fulfilled. "In vitro testing was conducted to show that Rapid HB, Rapid LB and Rapid MB fulfils the requirements of FDA recognized standard ISO 4823." "The results of Rapid LB and Rapid MB fulfill the requirements of ISO 4823." |
| Consistency (Similar to predicate devices) | Similar. Performance "was compared to the predicate devices ... regarding consistency... The results... are similar to Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB." |
| Contact Angle (Similar to predicate devices) | Similar. Performance "was compared to the predicate devices ... regarding contact angle... The results... are similar to Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB." |
| Working Time (Similar to predicate devices) | Similar. Performance "was compared to the predicate devices ... regarding working time... The results... are similar to Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB." |
| Intraoral Setting Time (Similar to predicate devices) | Similar. Performance "was compared to the predicate devices ... regarding intraoral setting time... The results... are similar to Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB." |
| Recovery from Deformation (Similar to predicate devices) | Similar. Performance "was compared to the predicate devices ... regarding recovery from deformation... The results... are similar to Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB." |
| Strain in Compression (Similar to predicate devices) | Similar. Performance "was compared to the predicate devices ... regarding strain in compression... The results... are similar to Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB." |
| Detail Reproduction (Similar to predicate devices) | Similar. Performance "was compared to the predicate devices ... regarding detail reproduction... The results... are similar to Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB." |
| Compatibility with Gypsum Type 3 / Type 4 (Similar to predicate devices) | Similar. Performance "was compared to the predicate devices ... regarding compatibility with gypsum type 3 / type 4... The results... are similar to Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB." |
| Linear Dimensional Change (Similar to predicate devices) | Similar. Performance "was compared to the predicate devices ... regarding linear dimensional change... The results... are similar to Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB." |
| Biocompatibility (According to ISO 10993 series and ISO 7405) | Safe. "The conclusion of the assessment is that Rapid HB, Rapid LB and Rapid MB are safe for their intended use." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the exact sample sizes for the "in vitro testing" conducted for each physical and mechanical property. It only states that the testing was "in vitro." This implies the data provenance is from laboratory tests rather than human clinical data. The country of origin for the testing is not explicitly stated, but the submitter is "3M Deutschland GmbH" from Germany.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable. The study described is a non-clinical, in vitro performance study of dental impression materials against established standards and predicate devices, not a study involving human diagnostic interpretation or ground truth established by medical experts for a test set. The biocompatibility assessment was conducted by a "board-certified toxicologist."
4. Adjudication Method for the Test Set
This information is not applicable, as the study is a non-clinical performance and biocompatibility assessment, not a clinical study involving adjudication of human read data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study focuses on the physical, mechanical, and biological properties of the impression material itself, not on the effectiveness of human readers using or interpreting data from the device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a dental impression material, not an AI algorithm or software. The performance assessment is inherently "standalone" in the sense that it evaluates the material properties directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical testing of physical and mechanical properties, the "ground truth" is defined by the requirements and methodologies outlined in the FDA recognized standard ISO 4823: Dentistry - Elastomeric Impression Materials, as well as the performance characteristics of the legally marketed predicate devices. For biocompatibility, the "ground truth" relies on the standards and guidance documents for biological evaluation of medical devices (ISO 10993 series and ISO 7405).
8. The Sample Size for the Training Set
This information is not applicable. There is no mention of a training set as this is a non-clinical performance study of a physical material, not a machine learning or AI model that requires training data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this type of device and study.
§ 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).