(114 days)
PRIME is used for manufacturing provisional crowns and bridge frameworks with up to two adjacent pontics in the anterior and posterior tooth area.
ABRO 1 is intended for the fabrication of denture teeth; RESITON GINGIVA is intended for the fabrication of denture bases.
PRIME TRANSPA, ABRO 1 TRANSPA and THERAPON TRANSPA are designed for the creation of bite splints, orthodontic splints and occlusal splints for bruxism.
The subject devices are blanks used in dental CAD/CAM milling systems by professional dental technicians to manufacture dental restorations. The devices are supplied in form of solid discs.
All devices are composed of the same basic material, Polymethylmethacrylate (PMMA), and are available in various models that differ in color and dimension.
The materials used for the submitted devices have a long history of safe use for the same or equivalent indications.
This document is a 510(k) Premarket Notification from Zirkonzahn srl to the FDA for their dental polymer blanks (discs) named ABRO 1, RESITON GINGIVA, PRIME, and THERAPON TRANSPA. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (UNION DENTAL S.A.'s IDODENTINE blanks) rather than proving the device meets specific performance acceptance criteria through a clinical study involving human patients or complex AI models.
Therefore, many of the requested criteria for describing a study proving the device meets acceptance criteria are not applicable to this type of regulatory submission for a medical device that is a material for dental restorations.
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance:
The document refers to performance testing according to ISO 10477:2018 and states that "All tested samples meet the requirements of the standard and show similar values as the predicate device."
The comparison table on page 5 provides specific physical property values for both the new devices and the predicate, with acceptance being meeting standard requirements and showing similarity.
| Criterion Type | Acceptance Criteria (Implied by reference to ISO standards) | Reported Device Performance (New Devices: ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA) | Comparison to Predicate (IDODENTINE blanks) |
|---|---|---|---|
| Biocompatibility | Established in consideration of ISO 10993-1:2010 Part 1 | Established | Same |
| Physical Properties | According to ISO 10477:2018 (meeting requirements) | According to ISO 10477:2018 | Same (Predicate was ISO 10477:2004) |
| Flexural Strength | ≥ 105 MPa (for new devices, as stated performance) | ≥ 105 MPa | Similar (Predicate: 83-94 MPa) |
| Water Absorption | ≤ 24 µg/mm³ (for new devices, as stated performance) | ≤ 24 µg/mm³ | Similar (Predicate: 22.3-25.8 µg/mm³) |
| Water Solubility | ≤ 0.3 µg/mm³ (for new devices, as stated performance) | ≤ 0.3 µg/mm³ | Similar (Predicate: 0.7-0.9 µg/mm³) |
| Residual Monomer Content | Resiton Gingiva: 0.71 wt%, Therapon Transpa: |
§ 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.