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510(k) Data Aggregation
(282 days)
For the fabrication of crowns, bridges and structures for implant supported provisional removable denture and appliance prosthetics.
-Provisional anterior and posterior crowns & bridges
- Implant and abutment supported prosthetics.
- Partial, complete and hybrid denture prosthetics (base and teeth) - Removable appliances (splint)
Harvest Dental Polymer Blocks are industrially polymerized, pre-colored or clear dental milling discs and blocks designed for milled fabrication of temporary anterior and posterior crowns and bridges (tooth-colored variants) or bite splints and dental CAD/CAM systems.
The Harvest Dental Polymer Blocks device is a dental milling disc and block designed for the CAD/CAM fabrication of temporary anterior and posterior crowns and bridges, as well as provisional removable denture and appliance prosthetics. The submission demonstrates substantial equivalence to its predicate device, Idodentine (K150432), based on similar technological characteristics, indications for use, and performance testing.
1. A table of acceptance criteria and the reported device performance:
| Requirement | Required Value (ISO 20795-1) | Required Value (ISO 10477) | Value (Submission Device) | Passed/Failed |
|---|---|---|---|---|
| Flexural Strength | ≥ 65 [MPa] | ≥ 50 [MPa] | > 90 Mpa | Passed |
| Water Absorption | ≤ 32 [µg/mm³] | ≤ 40 [µg/mm³] | 0.024 mg/mm³ | Passed |
| Water Solubility | ≤ 1.6 [µg/mm³] | ≤ 7.5 [µg/mm³] | 0.0000 mg/mm³ | Passed |
| Residual Monomer Content | ≤ 2.2 % | - | < 1.1 % | Passed |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample size used for each specific test or the specific provenance (e.g., country of origin, retrospective/prospective) of the testing data beyond stating it was performed in a laboratory.
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 as the acceptance criteria and performance evaluation for this device are based on objective, standardized physical and chemical property testing rather than expert-derived ground truth from medical images or clinical observations.
4. Adjudication method for the test set:
Not applicable. The performance is assessed against established ISO and ADA standards through laboratory testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a dental material, not an AI-assisted diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a dental material, not an algorithm. The performance testing is analogous to "standalone" in that it evaluates the material properties directly without human interpretation as part of the primary outcome.
7. The type of ground truth used:
The ground truth used for evaluating the device's performance against its acceptance criteria is based on:
- ISO Standards: Established international standards for dental materials (ISO 10477, ISO 20795-1).
- Biocompatibility Standards: ISO 10993 for biological evaluation of medical devices.
- ADA Standards: ADA 53 for Polymer-Based crown and Bridge Resin.
These standards define the acceptable range or threshold for specific physical, chemical, and biological properties.
8. The sample size for the training set:
Not applicable. This device is a physical dental material with established chemical and physical properties, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
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(245 days)
The Harvest Dental Polymer Blocks (ZCAD) are PMMA blanks for manufacturing temporary crowns and bridges by a CAD/CAM system.
Harvest Dental Polymer Blocks (ZCAD) are PMMA blanks.
The provided text is a 510(k) premarket notification letter from the FDA regarding a dental product. It does not contain information about acceptance criteria for a device's performance through a study. Instead, it is a regulatory document confirming substantial equivalence based on prior predicate devices.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document does not discuss performance studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.
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