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510(k) Data Aggregation
(282 days)
Harvest Dental Polymer Blocks
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 % | - |
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(245 days)
HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA)
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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