Zirconia Dental Ceramics

• K Number: K170894
• Device Name: Zirconia Dental Ceramics
• Manufacturer: CHENGDU BESMILE BIOTECHNOLOGY CO.,LTD.
• Date Cleared: 2017-08-01 ( 127 days)
• Product Code: EIH
• Regulation Number: 872.6660
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Zirconia Dental Ceramics are intended for crowns, multiunit bridges. Application includes both anterior and posterior bridges.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA regarding "Zirconia Dental Ceramics." It primarily addresses the substantial equivalence determination for the device and its indications for use.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this input.

Regulation Number and Section

§ 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.