PISCES PLUS (DW286 C)

• K Number: K020183
• Device Name: PISCES PLUS (DW286 C)
• Manufacturer: IVOCLAR VIVADENT, INC.
• Date Cleared: 2002-03-13 ( 54 days)
• Product Code: EJH
• Regulation Number: 872.3710
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Pisces Plus (DW286 C) alloy intended to be used for onlay, ¼ crows, telescope crowns, conus crowns, posts, short and long span bridges, PFM crowns.

Device Description

Pisces Plus (DW286 C) alloy

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) K020183 document for "Pisces Plus" does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

This document is a marketing clearance letter, which means the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This letter primarily focuses on:

• Trade/Device Name: Pisces Plus
• Regulation Number and Name: 872.3710, Base Metal Alloy
• Regulatory Class: Class II
• Product Code: EJH
• Submission Date: January 15, 2002
• Approval Date: March 13, 2002
• Indications For Use: For onlay, ¼ crowns, telescope crowns, conus crowns, posts, short and long span bridges, PFM crowns.
• General Controls: Mentions annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

It does not include:

1. A table of acceptance criteria or reported device performance.
2. Details about a sample size for a test set, data provenance, or a study.
3. Information on experts used to establish ground truth or their qualifications.
4. Adjudication methods.
5. MRMC comparative effectiveness study results or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This type of information, particularly detailed performance data and study design, would typically be found in the 510(k) submission document itself, which is often much more extensive and not usually fully included in the public clearance letter. The clearance letter confirms the substantial equivalence but does not elaborate on the specific testing performed to demonstrate that equivalence.

Regulation Number and Section

§ 872.3710 Base metal alloy.

(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.