(30 days)
The Perfit FS Dental Zirconia Fully Sintered Block is used for dental restorations using different CAD / CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.
The Perfit FS Dental Zirconia Fully Sintered Block consists of zirconium oxide which compresses ceramic for milling, grinding, and further firing. It is normally pre shaded, fully sintered and milled by dental technician with CAD/CAM machine for shaping artificial teeth such as crowns, bridges, veneers, inlay etc.
The Perfit FS Dental Zirconia Fully Sintered Block are zirconia oxide block made available in different versions and chemical compositions of various colors, shades and dimensions and will further process the discs by milling them to make final dental restorations such as crowns, bridges, veneers, inlays and on lays based on the anatomical rendering of the patient's teeth using CAD/CAM equipment. At the completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the Zr02 so that its final properties can be achieved.
They are available in different models that differ in various specification and color. There are white zirconia products(White) and colored zirconia products, and colored zirconia is also divided into Monolayer(A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, White) color products , Shade multi-layer(ML A1/A2/A3, A1M, A2M, A3M, A3.5M, A4M, B1M, B2M, B3M, B4M, C1M, C2M, C3M, C4M, D2M, D3M, D4M) color products.
The white zirconia is composed of Zr02+Y203+Nb205 and an additional inorganic pigment: Al203 and Other oxide. The color zirconia products are derived from the same zirconia powder as the regular white zirconia powder, with the addition of very small amount of inorganic pigments: Fe203 and other oxide. The inorganic pigments generate the color on the prosthetic dental device, after sintering at dental labs that matches natural color of patient's teeth.
The composition of the Dental Zirconia Block including the white zirconia and the color zirconia conforms to ISO 13356:2015. Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) and the performance conforms to ISO 6872:2015/Amd1:2018, Dentistry: Ceramic Materials.
Here's an analysis of the provided FDA 510(k) summary regarding the Perfit FS Dental Zirconia Fully Sintered Block, focusing on acceptance criteria and the study proving it meets those criteria:
Device: Perfit FS Dental Zirconia Fully Sintered Block
K Number: K222686
Predicate Device: K203590, "Perfit FS Dental Zirconia Blank, Perfit ZR UT Dental Zirconia Blank" manufactured by Vatech acucera, Inc.
This submission is for a dental material (zirconia blocks) used for creating dental restorations, not an AI-powered diagnostic device. Therefore, many of the typical acceptance criteria and study designs relevant to AI (like MRMC studies, human-in-the-loop performance, expert consensus for ground truth, training set information) are not applicable to this type of medical device.
The acceptance criteria here pertain to the physical, chemical, and biological properties of the material to ensure it is safe and performs as intended.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ISO Standards / Predicate Device) | Reported Device Performance (Subject Device) |
|---|---|
| Material Composition Conformity | |
| ZrO2 + Y2O3 + Nb2O5 + Al2O3 ≥ 99.0% (Regular White zirconia) | Composed of ZrO2+Y2O3+Nb2O5 and additional inorganic pigment: Al2O3 and Other oxide (white zirconia) |
| ZrO2 + Y2O3 + Nb2O5 + Al2O3 ≥ 99.0% (Pre-Shaded zirconia) | Derived from same zirconia powder as regular white zirconia with addition of Fe2O3 and other oxide (colored zirconia) |
| Conformity to ISO 13356:2015 (Material) | Conforms to ISO 13356:2015 |
| Inorganic pigments (Fe2O3, MnO2, and Er2O3 |
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.