(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 % | - |
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.