FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The A-dec Self-Contained Water System with Antimicrobial AlphaSan" is intended for use in general dental applications by providing water to the dental syringe, various handpiece ancillary devices, and cuspidor cup-fill. When used according to manufacturer's instructions, and in conjunction with the cleaner tablet ICX", the Antimicrobial AlphaSan" contained in the bottle helps to reduce microbial contamination.

Device Description

A-dec Self-Contained Water System

AI/ML Overview

The provided text from the FDA 510(k) summary for the A-DEC Self-Contained Water System does not contain any information about acceptance criteria or a study proving the device meets said criteria.

The document is a clearance letter from the FDA, stating that the device is substantially equivalent to a legally marketed predicate device. It defines the indications for use of the A-DEC Self-Contained Water System but does not include any performance data, clinical study results, or the methodology for any such studies.

Therefore, I cannot provide the requested information based on the given input.

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K Number

K032757

Device Name

A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE

Manufacturer

A-DEC, INC.

Date Cleared

2003-12-10

(96 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

The A-dec Self-Contained Water System is intended for use in providing water to the dental syringe, various handpiece devices, and cuspidor cup-fill. The system allows for flushing and waterline maintenance to help prevent contamination and maintain clean dental unit waterlines.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental water system. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement in a study as it pertains to medical device performance evaluation.

This type of information is usually found in the 510(k) summary or the actual submission documents, which are not provided here. The letter only confirms that the device has been found substantially equivalent to a legally marketed predicate device.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on the provided text.

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K Number

K962665

Device Name

A-DEC SELF-CONTAINED WATER SYSTEM

Manufacturer

A-DEC, INC.

Date Cleared

1996-08-22

(44 days)