SPIRIT, MODEL M, U; DOCPORTMACRO, MODEL M, U, L

• K Number: K061658
• Device Name: SPIRIT, MODEL M, U; DOCPORTMACRO, MODEL M, U, L
• Manufacturer: DENTALL CORP.
• Date Cleared: 2006-09-18 ( 97 days)
• Product Code: EBZ , EIA
• Regulation Number: 872.6070
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Non-diagnostic intraoral camera used by dentists to illuminate and magnify dental surfaces.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA for a dental operative unit and accessories (Trade/Device Name: Spirit/DocPortMacro). It does not contain information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications for AI/ML-based medical devices.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It pertains to a physical dental device, not software or an AI/ML product. Therefore, I cannot extract the requested information from the provided text.

Regulation Number and Section

§ 872.6070 Ultraviolet activator for polymerization.

(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.